INFORMING THE PUBLIC ON CLINICAL TRIALS
VICE REPORT- POSSIBLE CURE FOR CANCER?
CLINICAL TRIALS & MOBILE HEALTH APPS
SUMMER 2015
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www.clin-edge.com
137A Lewis Wharf Boston, MA 02110
MESSAGE FROM THE DIRECTOR
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Our mission is to facilitate every stage of the clinical trial process, from site selection to staff support, to patient engagement i
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In 2010, ClinEdge was a small, local newcomer to the marketing industry for clinical trials. We are now a respected firm, providing business development and patient recruitment services for clients across the globe. We operate through two distinct but complementary divisions, ClinEdge Network and ClinEdge Engage. Our mission is to facilitate every stage of the clinical trial process, from site selection, to staff support, to patient engagement.
BUSINESS DEVELOPMENT & PATIENT RECRUITMENT ClinEdge Network, our business development division, now comprises a database of over 200 top-notch investigators across North America. We vet all Network sites based on our own high standards of clinical excellence and send them competitive trials suited to their specific strengths. This allows us to boost efficiency for our sponsor clients and expand pipelines for our sites. ClinEdge Engage, our full-service patient recruitment and marketing division, has the technical expertise to overcome any enrollment challenge. Our patient recruitment specialists draw from a vast array of online, traditional, referral, and community outreach services. We customize each marketing strategy to the individual needs of the study or site. We aim to maximize study budgets and grow our sites’ local brands. As the President of ClinEdge, I never lose sight of the three guiding principles that have defined us so far:
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TALENTED PEOPLE: What we do energizes us. All the members of the ClinEdge team are experts, and our staff’s commitment to high-quality study and site support has consistently distinguished us from our competitors.
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FOCUS ON SITES: Sites are at the front line of clinical research. That is why we concentrate on boosting site efficiency and preparedness. Through persistent collaboration, we identify and implement service packages designed to achieve each site’s individual goals.
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HONEST PERSPECTIVE: We continue to manage our business around the evolving needs of our clients. We are always looking to deepen our partnerships with candid, consistent communication.
To all our clients: ClinEdge’s success would not have been possible without you. Thank you for your ongoing confidence. We look forward to what the future holds and pledge to keep exceeding expectations.
Sincerely,
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CONTENTS
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Message from The Director
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The Future of Clinical Trials
Message from Christian Burns, President of Clinical Operations and Marketing at ClinEdge
A look into upcoming industry trends and expectations
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CLINEDGE CULTURE
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THE POWER OF THE PHONE: Clinical Trials & Mobile Health APPS
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A look back at ClinEdge’s accomplishments and memorable moments with the team
Featuring Apple’s new ResearchKitTM and addressing how mobile use will affect the clinical research industry
25 Things to Know About ClinEdge Do you know how close ClinEdge is to the Boston Harbor? Find out with our fun facts
Industry Q&A with Nick Zanotta Nick Zanotta, Director of Clinical Operations, shares his take on the industry and ClinEdge
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17 Informing the Public on Clinical Trials
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Vice Special Report: Killing Cancer
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CISCRP: Informing the Public on Clinical Trials
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Employee Spotlight: Lauren Fopiano
A possible cure for cancer? Vice explores the possibilities of a new method for treating cancer patients
Knowledge is power in the clinical research industry ; Find out how CISCRP keeps patients informed in clinical trials
Lauren Fopiano, Associate Director of Business Development, and her background in the industry
Contributions
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CREATIVE PROCESS: BRaNDING A CLINICAL TRIAL See inside ClinEdge Engage’s design process for branding clinical trials
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OUR PORTFOLIO: ClinEdge EngAGe
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THE RISE OF WEB DESIGN: INFOGRAPHIC
Our portfolio displays work from site and sponsor projects. See more online at www.clin-edge.com!
In this graphic see how web design, along with technology, has grown exponentially over the past decade
Design & Direction
Sources
Ashley Eldridge Georgia Ward Jamie Reddish John Hawley
https://www.ciscrp.org/
Copywriting & Editing Sarah Yau Kelly Leatherman Karly Domsky Doug Cavers Nicole Stratton
http://www.clin-edge.com/ http://csdd.tufts.edu/files/uploads/TCSDD_Social_Media_Final.pdf http://www.appliedclinicaltrialsonline. com/future-clinical-trials-are-here-andhow-they-may-succeed
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INDUSTRY UPDATE
THe future of clinical trials
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crucial
...it is to keep reinventing the way we conduct studies for greater success.
a result of skyrocketing research and
Patients sign an electronic consent form, which includes a
development costs, biopharmaceutical
video of a physician explaining trial details. Throughout the
commercialization and approaches to clinical
clinical trial, each patient is able to access physicians either
trials are shifting to maximize success.
virtually or at nearby medical centers. Nurses visit the subjects at home to collect study samples.
These days, many therapeutic areas in clinical trials are experiencing market saturation, which forces
The benefits of this strategy include reduced site initiation fees,
biopharmaceutical companies to focus on patients with rare
fewer subject visits, remote access to study subjects, accurate
diseases. Moreover, this shift in focus has coincided with the
medical data, the elimination of source document verification,
rise of electronic consenting and virtual clinical trials.
lower subject dropout rates, and higher patient retention.
Consequently, selecting feasible sites for rare disease
The biggest challenge for virtual clinical trials is building
studies has become more difficult, because patients
the level of trust required to engage remotely with patients.
with such disorders often live in remote regions, far
Pharmacies and doctors’ offices typically build this trust in
away from a participating research site. Therefore, many
person, not on social media and the Internet.
biopharmaceutical companies have starting conducting virtual clinical trials to increase patient recruitment and retention.
Here’s how a virtual clinical trial works: Sponsors engage potential patients through online avenues, such as social media and email updates. Once a patient agrees to learn more about a trial, the sponsor mails the patient a package of mobile health devices that collect diagnostic data. This data is sent back to the sponsor and automatically uploaded to its EDC database.
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ClinEdge Culture Our team is continuously growing together through hosting events, attending conferences, and collaborating on projects. See some of our recent highlights below.
Valentine’s Day Baking
NAMI Walk
Engage Launch Party
CLINEDGE COOKOUTS
The ClinEdge team spread the
The ClinEdge team proudly
We recently launched our
The ClinEdge team enjoys
love with baked goods this
supported Mental Illness
division for patient recruitment
fabulous Fridays by the water in
Valentine’s Day. These chocolate
Awareness Month at the NAMI 5K
and marketing, ClinEdge
the summer, enjoying the harbor
cupcakes were a fan favorite!
Walk at Artesani Park. The team
Engage. The event was hosted
views and great food!
was out in full force, including
at the Revere Hotel Rooftop
some help from official ClinEdge
and was a great success!
mascots: Sloan, Vinny, and Lulu.
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97% ICE BUCKET CHALLENGE
1st annual Site Meeting
CONFERENCES
Enrollment Goals Met
The ClinEdge team accepted the
ClinEdge Network hosted its first
The ClinEdge team attends
By December 2014, ClinEdge
ALS Ice Bucket Challenge and
site meeting in Boston with almost
many conferences throughout
Network sites had met enrollment
raised $750 for the Pete Frates
all sites in attendance. Stay tuned
the year, including MAGI
goals on over 97% of studies.
for details about our next site
West, OCT New England, Site
meeting !
Solutions Summit, and the CNS
#3 Fund.
Summit among others. Stop by our booth and connect with the team!
As a full service business development and marketing company , we know that collaboration is a vital part of our success. Every day we grow and work together as part of a team. What makes the ClinEdge team unique? Our dedication to success, unique ideas, and forward thinking help to create the culture of ClinEdge.
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Recent years have seen a rapid proliferation of smartphone applications that aim to improve their users’ mental and physical health. Apps can now analyze workouts, monitor sleep patterns, track diet and nutrition, and connect patients to expanding healthawareness communities. In short, personal health is “going mobile.� Therefore, leaders in the medical research industry are now asking an essential question: how can researchers use mobile apps to improve patient recruitment and retention for clinical trials? 5
ResearchKittm Storms onto the Scene On March 9th, Apple publicly announced ResearchKit™, its open-sourced mobile platform designed specifically for clinical research. The apps created with technology on ResearchKit™ allow investigators to manage all aspects of a clinical study remotely. Here’s how it works: researchers and developers use the tools available on ResearchKit™ to create an app suited to the specific parameters of their study. Then, anyone with access to the platform can apply to participate. For applicants who meet protocol criteria, the app provides patient-education resources and electronic consent forms. Once the trial is underway, the ResearchKit™ app tracks relevant medical information and relays it directly to the study team. These data may come in the form of patient questionnaires on the app’s interface; an app can also collect information via the iPhone’s builtin sensors, GPS locator, or external Bluetooth devices. The early results have been promising. When ResearchKit™ launched, it featured study apps in five indications: asthma, Parkinson’s, diabetes, breast cancer, and cardiovascular disease. In just a few weeks, the five apps had accrued a combined total of about 60,000 patient leads. The cardiovascular study saw over 11,000 patients apply in the first day alone. And these leads weren’t dead-ends; in just one day, researchers at Mount Sinai’s Icahn School of Medicine in New York enrolled 25 patients through their asthma study app.
“To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country,” Alan Yeung, a researcher in the cardiovascular study, explained to Bloomberg News.
“That’s the power of the phone.”
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ResearchKit’s™ big data capabilities make it particularly attractive to large cohort studies. Having more information
The Promise of Training Apps
improves accuracy; in one study, Google found that
Health and fitness trainers constitute by far the largest
crunching colossal data sets through an artificial intelligence
market of all mobile health apps. According to market
system could more accurately predict drug efficacy across a
research firm Research2Guidance, there are over 100,000
variety of indications. ResearchKit™ may be the only tool out
training apps in what is now a multimillion-dollar industry.
there now that can collect such quantities of data in a short
Training apps provide a diverse range of services. Some
period of time. However, the platform does have its limitations. For one, study apps on ResearchKit™ will only be able to recruit patients who own iPhones, which many people cannot afford. Therefore, the data gathered by ResearchKit™ will tend to over-represent affluent, Western populations. Moreover, since ResearchKit™ gathers all data remotely, investigators cannot verify the information their patients submit. What if a patient misunderstands something in a questionnaire? Or simply hits the wrong button on the app interface? Such accidents could throw the validity of a study’s findings into doubt.
seek to inform users about the consequences of certain lifestyle choices. Such apps include MyFitnessPal, which provides nutritional information on eating habits, and FitStar Personal Trainer, which crafts personalized exercise routines based on user input. Other training apps aim to coach patients within a specific indication, such as The COPD Navigator app, which tracks COPD patients’ symptoms and adherence to treatment. The average smart phone has several capabilities that training apps use to collect data. GPS locators can track a person’s activity levels, measuring distances walked each day. Motion sensors can track how much someone tosses and turns at night. Cameras can monitor when a person makes mistakes during a workout. But medical research often requires more in-depth information about a person’s health. That’s where thirdparty devices come into play. The asthma study app on ResearchKit™ has already demonstrated their utility; in that study, participants were given a Bluetooth-connected inhaler that allowed the research team to track their medication use. What if, instead of an in-patient brain scan, clinical researchers let participants stay home with a headband that records neurological activity? If that sounds like science fiction, think again: the wearable tech company Muse is already offering such a headband to help with
There are also privacy concerns about ResearchKit’s™
meditation. Other wearable third-party devices include
access to sensitive health information. For its part, Apple
a shirt that detects muscle movements, a mattress that
has claimed that it cannot view users’ medical data, which
adjusts to sleep patterns, and wristbands that monitor
routes directly to the research team. Apple has also required
heart rate and blood oxygen content.
that all ResearchKit™ apps get IRB approval before going
However, the technology behind training apps is not yet
live. But in an age of growing mistrust about the role of big data, these concerns could prove a flashpoint for controversy.
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on par with the high standards of clinical research. In too many cases, the sensors they use are unreliable, which has sparked some debate about their safety. For the time
being, the medical research industry should remember the case of Health Discovery Corp, which the FTC fined almost $18,000 for making inflated claims about its app’s ability to evaluate melanoma risk. But if medical researchers should be cautious about training apps, they can also be hopeful. Given the current rate of tech innovation, these apps and their third-party devices could be viable for clinical trials sooner rather than later.
Building Bridges with Patient Networks There’s another type of platform that could play a growing role in patient recruitment for clinical trials: patient networks. These are online communities where patients can interact with each other and reach out to doctors. Calling these networks ‘apps’ is a bit of a misnomer, because they can exist anywhere on the Internet. Nevertheless, patient networking pioneers, such as Panoply and FirstLine, have opted for the greater convenience of going mobile. Let’s start with Panoply, a new networking app for psychiatric patients. Here’s how it works: users post their negative thoughts, feelings and reactions to events, much as one would post a status on Facebook. Other users then leave comments, in which they point out possible thought-distortions and provide constructive criticism. Administrators monitor these postings and eliminate any abusive language. Tapping into these patient-to-patient networks could benefit clinical trial recruitment considerably. They provide self-segmented populations of active, interested users who are prime targets for clinical trial outreach. Conceivably, research companies could even create their own patient networks, which could increase the users’ investment in their studies and brands. The other networking app, FirstLine, connects patients to doctors ‘on-demand.’ It’s pretty simple: for a fee of $15 per month, users can text, video message or call doctors to ask for medical advice. For $200, they can call a doctor for an at-home visit. Would this not be a great way to make clinical trial participants feel more connected to research site teams?
Obviously, much of this is conjecture. But in our tech-focused times, research leaders should look to the future of clinical trials. Mobile health apps could be an exciting opportunity to get more patients involved in trials, especially since their growth shows no signs of abating. Apple. Press. Apple Announces ResearchKit Available Today to Medical Researchers. Apple.com. Apple Inc., 14 Apr. 2015. Web. 12 May 2015. Cortez, Michelle F. “Thousands Have Already Signed Up for Apple’s ResearchKit.” Bloomberg.com. Bloomberg, 11 Mar. 2015. Web. 12 May 2015. Taylor, Nick P. “Google Applies Large-scale Machine Learning to Drug Discovery.” FierceBiotechIT. Fierce Markets, 9 Mar. 2015. Web. 12 May 2015. Cruz, Emmelyn. “Apple Requires ResearchKit Apps to Get Ethics Board Approval.” Headlines Global News RSS. HNGN, 30 Apr. 2015. Web. 12 May 2015. Wanjek, By Christopher. “Are Health Apps Harmful or Helpful? Experts Debate.” LiveScience. TechMedia Network, 14 Apr. 2015. Web. 12 May 2015. Bartlett, Jessica. “FirstLine’s Doctors on Demand Is the Uber for Health Care.” Widgets RSS. American City Business Journals, 23 Mar. 2015. Web. 12 May 2015.
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Over 70% of ClinEdge employees commute to work on public transportation…living sustainably, always!
ClinEdge is split into two divisions—Network and Engage. ClinEdge Network is a unique, exclusive and geographically diverse network of high-performing research sites across North America. ClinEdge Engage is a marketing, design and patient recruitment agency.
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ClinEdge has strong partnerships with over 36 major sponsors and CROs. Through these relationships ClinEdge assists our network of independently owned sites by developing a strong pipeline of study opportunities.
Our headquarters are located at Lewis Wharf in Boston’s North End only 40 feet from the beautiful Atlantic Ocean. It is the city’s oldest residential community and known for its delicious ItalianAmerican fare.
8 ClinEdge Engage supports studies across the globe, from North America to Europe to Asia.
ma ch
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ClinEdge has a growing team of motivated professionals, comprised of expert marketing personnel and a dedicated business development and clinical operations team. As a lean, medium sized company, it’s just small enough to cater to every client need.
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Jamie, our Senior Web & Graphic Designer, created the artwork showcased in the office. There are multiple paintings representing ClinEdge’s divisions in beautiful vibrant colors.
Our Espres so
ClinEdge is a full-service business development and marketing firm dedicated to the success of clinical trials. We represent a network of highly qualified research facilities and pharmaceutical industry professionals. We also manage individualized marketing and patient recruitment strategies.
in
ys running ! lwa a s ei
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Having worked with over 60 pharmaceutical and biotech companies, we understand the importance of the relationships we make and the flexibility needed to work within a wide range of therapeutic indications.
Summer cookouts by the harbor are a favorite at ClinEdge. We have a surprising number of grill masters in the office!
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Many of ClinEdge’s educated staff speak at over 12 conferences throughout the year, and attend nearly 35 in the US and internationally.
11 ClinEdge Engage develops a best-fit recruitment strategy including tactics such as community outreach, media buying, email blasts and newsletter campaigns to provide you with only the services you need to ensure optimal results.
90%
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ClinEdge Network sites have successfully enrolled, or over-enrolled, over 90% of the studies they have been awarded.
A typical Network clinical research site has been conducting research for an average of 13 years.
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As a child, Christian Burns, President of Clinical Operations and Marketing for ClinEdge, spent his time enjoying a good fox hunt in the rolling hills of Philadelphia.
17 By maintaining partnerships with technology development companies, ClinEdge is able to stay on the forefront of marketing trends and technological advancements to reinforce our marketing services.
staffs a full 18 ClinEdge in-house Call Center
of experienced study coordinators.
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ClinEdge Engage utilizes extensive experience across a wide variety of therapeutic areas to analyze a study protocol and develop a customized, costeffective recruitment strategy to drive enrollment.
20 ClinEdge’s headquarters is surrounded by the most highly saturated area of biotech and pharmaceutical companies–with over 180 companies in a 40 mile radius!
22 Over 35% of our employees have prior experience running and/or working at a clinical research site. We have an insightful perspective into the inner workings of clinical research.
Want to learn more about ClinEdge?
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Visit us Online
www.Clin-Edge.com Meet Sloan, the office mascot!
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B
ig changes are on the horizon for clinical research, and ClinEdge is readily adapting. ClinEdge’s own Nick Zanotta comments on the Research & Development Industry, life at ClinEdge, and the future of clinical trials. Feature by: Kelly Leatherman & Douglas Cavers
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Industry Q & A Q: What is your definition of a successful research site? A: Successful research sites, we’ve found, are those that are starting to vary the indications and therapeutic areas in which they specialize. There are quite a few research lulls that occur in multiple therapeutic areas, and the sites that have varied their indications are able to make it through those lulls. And it’s not that you have to be experienced in all the different therapeutic areas and indications. But having a decent range, such as employing an internal medicine practitioner, Nick Zanotta
Director of Clinical Operations
dermatologist, or neurologist, can be helpful. Those specialists would be able to bring a very large array of different study opportunities to the table. In addition, I would say the following characteristics have also been shown by some of the most successful sites I have had the privilege to
STATS Joined ClinEdge: 2012 Division: ClinEdge Network Location: Boston Office
work with:
1. High Communication Skills 2. Ability to Meet Deadlines 3. Declining the wrong studies quickly with reasoning
Q. What advice would you give to a site that wants to break into new therapeutic areas so they can ride out those lulls? A: It’s definitely tough out there, because there are so many competitive sites currently established in the research fields. So it’s really about the right place and the right study opportunities. Now,
“ I oversee the ClinEdge Network division which offers very personalized business development services to a network of sites across the US and Canada. With that business development service we’re bringing high quality study opportunities to the right sites.” -Nick Zanotta
getting your foot in the door is really about following up with the contacts you have at CROs and pharmaceutical companies and making sure their notes are up-to-date in the database about your site’s capabilities. That’s especially true if you are making new partnerships out there in the surrounding community with additional specialists in order to access those different patient populations.
Q. Elaborate on that. What advice would you give to a less experienced or new research site trying to break into the field or get awarded their first study? A: For new sites, I always say it’s great to make connections with established sites to ensure you have a knowledgeable mentor who can help you make the right decisions for your site or an experienced staff from within the industry that knows the ins and outs of site selection. Also, this will help to make sure you are taking the right steps to get awarded study opportunities, and when you are awarded those study opportunities, always identify appropriate budgets for your site. You have to be able to negotiate those budgets. Evaluating contract language is one of the biggest issues for new sites right now, I would say, in the research industry. Unfortunately, new sites are taking a lot of blame for creating low-fare market value because either they are not negotiating budgets at all
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or they are not able to negotiate budgets adequately. At the end of the day, these research sites are businesses and they need to feed families, but by accepting very low budgets, they are not just hurting themselves but everybody else in the research industry. BlueTheory Clinical Trials, our sister company, offers a great BSA program that is extremely transparent and helps new sites with budget and contract negotiations as well as handling receivables, completing competitive feasibility questionnaires, and identifying the best study opportunities for new sites’ pipelines.
Q. What are some new developments in research that you feel would be beneficial to general public or something that you’ve seen in the pipeline that will be exciting? A: There is always a lot that is going on to benefit the patients and general public; for instance, the FDA is starting to look more at biomarkers as a means of identifying patient populations and drug efficacy at an earlier stage of the clinical research process. The biomarkers help with earlier kill times on therapeutics. In the sense of research, biomarkers can show whether your study program is actually affecting your pre-identified endpoints, so you can close down the programs that do not work before spending thousands or millions of dollars on larger clinical trial opportunities. It was discussed pretty in-depth at the Early Phase Clinical Trial Development conference I attended in Philadelphia this year.
Q. What are some other issues that you think are important for the research industry right now?
on the same page, but there is a stigma against saying that your site is not doing as well. That’s when we see the communications being mishandled or misinterpreted. One of the biggest reasons communication is an ongoing hurdle is because everyone in the industry is overworked, having a thousand and one things to do on their plate every day. So that really can take a big toll if somebody needs you to turn something around immediately and you are not able to. That’s some of the processes that ClinEdge and BlueTheory are working to identify to improve the communication process.
Q. Just one more question. What do you think makes ClinEdge unique in the industry? A: We are definitely a leader when it comes to communication. We have a good solid team set up that not only works with our sites to find them study opportunities, but also makes sure to encourage consistent and accurate communication. By accurate I mean, rather than asking a lot of questions that may or may not impact the site’s study opportunities, we are looking to identify the situations that really require getting on the phone and talking through the issues between the sites, sponsors and CROs. We are also working very closely with many major CROs and crafting more streamlined approaches to site management. There are a lot of great companies out there, and many of them do things differently than we do, but I would say that ClinEdge has the highest quality of communication of our competitiors in the industry today.
CONNECT WITH NICK! Nick@Clin-Edge.com | 857.496.0054 ext. 511
A: Communication is one of those issues that kind of permeates everything. Like when sites do not meet the enrollment goals that they had initially stated. Communication plays a role because we often see CROs and sponsors are looking to help sites that are not doing as well on study opportunities, but the sites aren’t forthcoming with information. Sites are really trying to figure it out on their own, but they could take advantage of the help offered by sponsors and CROs. At ClinEdge, that is something we are working on by opening up lines of communication for when sites are struggling with study opportunities. We identify what the CROs and sponsors can do to help them bring up those enrollment numbers. Everyone has deadlines to meet, everybody makes those promises to CROs or sponsor; but we’ve got to remember it’s more about working together, not against each other. I think everybody is striving to get
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: t r o p e r l a i c e p s Vice ancer
I
C g n i l l i K
n “VICE Special Report: Killing Cancer,” VICE goes inside cutting-edge cancer research labs to explore
Dr. Stephen Russell at the Mayo Clinic is using an
how injections of HIV, measles and other viruses
engineered measles virus to fight bone cancers. Measles
can treat cancer and save lives.
therapy is many of these patients’ last hope. One week after the infusion, the study participants are optimistic.
Dr. John Bell, from the Center for Innovative Cancer Research at the Ottawa Hospital in Canada, was the first
Stacy, who was selected for the 2nd phase of the measles
to identify the viruses that attack cancer cells without
therapy study, has multiple myeloma. Myeloma is an
hurting surrounding body cells.
aggressive cancer that causes bones to become so brittle that they break. Most patients die within 5 years.
These viruses act like a cancer-seeking smart missiles;
“ 15
once they’re in the bloodstream, they target and attack
Stacy’s myeloma had spread throughout her body and
proteins exclusively found in cancers. First the virus
a tumor on her head had grown to the size of a golf
enters a cancerous cell and replicates itself until the
ball. She had taken every available treatment without
cell explodes. Then the virus stops the cancer from
lasting results. A single injection of measles changed all
suppressing the immune system, which alerts the body to
that. Despite intense headaches, Stacy’s tumor shrank
tumors. The immune system then eradicates the exploded
dramatically, and she has been in remission for 18
cancer cells.
months. Her case was the first in history where a virus had reversed cancer all over the body.
My life, like most people’s, has been negatively affected by cancer, and the thought of my young children living in an age where this is no longer humanity’s No. 1 health fear was simply overpowering. – Shane Smith, founder of Vice Media
”
Dr. Juan Fueyo at MD Anderson Center in Texas is also using a virus to target cancer. Specifically, he is hoping that Adenovirus, which is responsible for the common cold, will attack brain tumors. In a mice study, he found that Adenovirus completely eradicated brain tumors. Mike O’Connor has a malignant brain tumor and received an Adenovirus injection as a part of the study. Six weeks after the injection, Mike’s brain scan showed that his
tumor had stopped growing. Experts are working to fasttrack the Adenovirus therapy through the FDA. The measles and Adenovirus treatments are both in the early stages of testing; they may or may not succeed. However, one treatment has proven consistently effective for leukemia: HIV.
I feel confident saying to people now, we are going to treat people and they’re going to get cures from these diseases and it’s going to happen in our lifetime. – Dr. John Bell, Cancer Researcher Five-year-old Emily Whitehead has acute lymphoblastic
Despite the amazing results of the trials, a lack of funding is
leukemia. In 2012, after two years of chemotherapy she
blocking further research from moving forward. Ever since
relapsed for the second time.
the Great Recession, philanthropic support has dried up and obtaining government funding is near impossible.
Even though doctors assured Emily’s parents the treatment would not infect her with HIV, they were understandably nervous. Three adults had undergone the therapy, and their reactions were severe. Emily’s turned out even worse. She suffered from a 106-degree fever and spent 14 days in a coma.
She went from 85-90% chance of survival to under 30%” –Tom Whitehead, Emily’s Dad
Fortunately, she survived the infusion. 28 days later, a bone marrow examination showed there were no signs of leukemia and three and a half pounds of the tumor
Dr. June predicts that the drug will be FDA-approved
had been eradicated. Two to four weeks later, Emily was
by 2016. If similar response rates hold across a wider
in remission. Her case was the first pediatric test of HIV-
population and viruses can be manipulated to attack
based therapy for cancer. Since then, 39 children have
other cancers, it would be a paradigm shift in treating this
been treated so far and an astonishing 90% have gone
devastating disease.
into remission.
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Informing the Public on Clinical Trials Why participate in a clinical trial? What are the benefits and risks of participating in clinical research? The Center for Information and Study on Clinical Research Participation (CISCRP) is the first nonprofit organization dedicated to educating and informing patients, medical research communities, the media, policy-makers and the public about the clinical research process.
FOR PATIENTS, FAMILY MEMBERS, AND THE GENERAL PUBLIC CISCRP offers a public Education Center with resources about clinical trials and what it means to be a research patient. CISCRP can also help you locate ongoing clinical trials through its free service called SearchClinicalTrials.org.
FOR PROFESSIONALS CISCRP also helps professionals better understand study volunteers with polls, surveys and other data. The CISCRP store offers materials that you may order for your clients and patients to help them understand clinical research.
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The Edge interviewed Ken Getz, the creator of CISCRP, to find out more about the organization, its mission, and the role ClinEdge has in educating the public about the clinical research process. THE EDGE: Could you please introduce yourself and tell us a bit about your organization? KEN: I’m Ken Getz, a member of the faculty here at the Tufts School of Medicine. I am the Director of Sponsored Research and an Associate Professor. About 11 years ago I started a nonprofit called the Center for Information and Study on Clinical Research Participation (CISCRP). Its mission is to educate the public and patients about clinical research and the role participation plays in advancing public health. As I mentioned, it is 11 years old and has a staff of 10 people, and we have a massive volunteer community today that helps CISCRP implement a variety of initiatives. We have live educational events that we run around the country called AWARE for All, conducted throughout major cities. We have digital and print materials that we offer for free to research centers and patient advocacy groups that are looking to educate their communities about clinical research and what it means to be a participant in the research process. We also gather a lot of data used by research professionals to understand how they should be communicating with the patients and public communities, so they have data to help them understand patients’ experiences as study volunteers. THE EDGE: CISCRP has a huge impact on volunteer comprehension as compared to competitors. What do you think contributes to this success? KEN: I think the bottom line is that we’re all about being a service to the public and patient community. Everything we do we want to translate into language that is easily comprehended and easily used by the patient community. It’s all about patient engagement and creating ownership for the things that we do among the public and patient community. We want patients to feel that CISCRP is really advocating for them. Competitors have a wealth of information, but this information is tailored toward the research community with the sense that patients may refer to that information through their research connections or healthcare provider. We’ve always taken the opposite approach: the public always comes first and that’s how we’ve developed all of our material. THE EDGE: Interesting, so how do you approach outreach to the public? How do you spread that information when research studies are ongoing?
KEN: It’s such a great question because every individual clinical team or study team wants to engage with patients. They want to fill a clinical trial and raise awareness of a study. That naturally creates a narrow focus and a bias. The bias is that communication’s purpose is to stimulate interest in participating in “my study.” CISCRP believes it’s all about raising awareness and informing people. By educating people, they will readily make the choice to participate in a study that makes sense to them. We try to create what some have referred to as the “ground cover.” We want to raise awareness and provide context so patients understand the connection between research and their own healthcare options, as well as the greater benefit their participation brings. By doing that, patients will ultimately respond to the very narrowly focused outreach efforts. THE EDGE: What does it mean to educate the public? KEN: It means being sensitive to cultural preferences. We have to be aware of learning styles. Some people love print, some people love short messages pushed through social media, and some people love in-depth videos. We have to be remarkably sensitive and flexible to accommodate different learning styles and ways to build awareness. We also really work hard to engage a grassroots volunteer community. The best way to do outreach is to reach people who are physically in a specific community. These people can interact directly with subpopulations and special needs of individual communities. We do a good job of building that out-reach army! We have a lot of patients who have been in trials who’ve become our ambassadors. Some of them go out to local libraries and community centers and talk about their experiences. They are people who are so committed to providing education. That is a critical way that we engage the community. It’s really at the grassroots level. THE EDGE: You touch on an important point. The truth helps foster dialogue about the benefits and risks of clinical research trials. What do you think is the greatest challenge to educating the public? KEN: Your suggestion is a good one. I think that there is a lot of misperceptions, some of which date back to over 25 years ago. This misinformation has been so ingrained in so many people that you have to work hard to correct the myths. In the early 2000s, for example, a national magazine had a cover of a patient in a hospital gown sitting in a dog crate. The title of the publication was inferring patients were being turned into guinea pigs. It’s that kind of misperception that we’re combatting all the time. The good
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news is that the public is just as distrustful of the media that they receive. When a person is really motivated to learn people are willing to suspend their misbeliefs to try to get at the truth. For us it’s all about balance and being there when people are ready to receive more information. We have people in our volunteer community who send us notes all the time. A local paper in Arizona, for example, sent out a paper with a headline about clinical trials. All the facts presented were incorrect, so we then sent a letter to the editor of the paper and the journalist who wrote the story, providing them with a list of facts to take into consideration next time they communicate with the public. We are trying to make the journalistic community more responsible. We have people who pay attention to social media conversations, and We’re already when someone tries to starting to see posi- engender a level of fear tive movement in the that is not based on we try to provide public view on the fact, references and links research enterprise. for people to find out This means a much more information on smaller percentage of their own. It’s a huge There is a lot of people are thinking battle. misinformation that that volunteers are we have to undo, but being used as guinea we’re starting to make some strides. We are pigs than before. starting to do some research on perceptions. We’re already starting to see positive movement in the public view on the research enterprise. It’s taken 10 years, but we’ve moved it 7 percentage points, so we keep working at that.
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THE EDGE: What do you think has been your most successful education initiative and why? KEN: Our AWARE for All program is the most successful and is now expanding to Europe. We receive more requests to do this program every year than we did in prior years. We get about 300 to 500 attendees from the public and patient communities. As part of the AWARE for All event, people who’ve participated in clinical trials are recognized with a certificate. THE EDGE: Are there any upcoming initiatives? KEN: One that I’m really excited about which hasn’t fully launched is our museum initiative. We’re going to be doing a science museum program where we educate children through high school-aged young adults about what it means to be a study volunteer. We will rotate through 12 museums
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throughout the country with a traveling exhibit. Most people don’t realize that museums are the best way to reach a younger audience. More people in that age group attend museums every year than go to Walt Disney World and sporting events combined. That’s going to be a big outreach program for us. We will tie it in with local curricula and science classes to reinforce what they’re learning. THE EDGE: That sounds like a great way to target a younger audience. KEN: We are trying to take one of these stations that would be set up in a museum and bring it to our AWARE for All events. That way people can interact with the exhibit and we can use that feedback to inform the museums that are interested in running the program. THE EDGE: Where do you see CISCRP in several years? KEN: I am just so proud of everything it has accomplished. I see us continuing to expand and grow. Western European demand for our education and outreach has skyrocketed. We’re getting requests in Asia, which is very exciting for us. Being international will be one of the largest changes that you’ll see. Research centers are giving out our materials all around the world. We’ll often get a company or a government agency that needs material translated and we will do it, and oftentimes they will donate that material back. That is how we get our library of information translated. THE EDGE: How will volunteers play a part in this expansion? KEN: Another big part of what we do is engage our volunteer community. We have very passionate ambassadors who focus on a specific disease, and others who have made themselves broadly available. Some get involved with planning our events. As we expand internationally, managing that vast army can become even more challenging, but just as exciting for us. THE EDGE: What do you think are the most important trends in informing the public on clinical trials? KEN: One of the trends that also helps explain our growth and success is the patient-centricity movement. It’s a fascinating concept. Historically, drugs and devices have been developed in a more product-centric approach, in which you have several scientists in a company review literature on basic research and define a research program. Then, they would guide that program through various stages of research and development, where you have clinical research teams conduct trials where they would recruit patients. The patient-centric approach, which is a movement gaining traction, says that instead of using the science alone
to define a research program, why not let patients define the research program? Yes, use the scientific evidence, but let patients talk about what the critical needs are based on their experiences.
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Sometimes research focuses on a specific The patient centric objective that is not approach, which is a the greatest priority movement gaining to the patient. Letting traction says that inpatients provide instead of using the sciput into the process will allow patients to ence alone to define a be more engaged and research program, why have more ownership not let patients define of the research. This the research program? will be more relevant to them, and it could attract more volunteers when patients are partners in the research process. It’s such a simple concept, but it is a complete reversal in how drugs have been developed. With the advent of social media and big data, you’re collecting data from patients that is unstructured: when patients are talking on social media sites about how a drug makes them feel, for example. Taking that information and cycling it back into the pharmaceutical companies and device companies give them even more feedback. The technology today can collect this all in real-time. The patient-centricity movement is the convergence of patient engagement and empowerment, big data, and the use of electronic medical information that can be collected in real-time. This includes more open innovation platforms where you’re now collaborating with people within and outside of the company. It’s making it appropriate for patients to be a part of the research process.
INTERVIEWEE BIOGRAPHY Ken Getz, Founder and Board Chair Ken Getz is the director of sponsored research programs and an associate professor at the Center for the Study of Drug Development, Tufts University School of Medicine, where he studies R&D management and operating models, investigative sites, outsourcing, and study volunteer trends and policies. Ken is also the founder and owner of CenterWatch. A well-known speaker at conferences, symposia, universities and corporations, Ken has published more than 200 articles and chapters in peer-review journals, books, and in the trade press. He is the author of two nationally recognized books for patients and their advocates titled, Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and the recipient of several awards for innovation and scholarship. Ken has held a number of board appointments in the private and public sectors, including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative.
Learn More at www.ciscrp.org
THE EDGE: How do you think ClinEdge can help CISCRP’s mission? KEN: Believe it or not, many pharmaceuticals and contract research organizations (CROs) forget that the best way to engage patients is through engaging sites. No patient should ever go through a clinical trial experience without having a strong rapport with the site study staff. In fact, there have been direct patient pilot programs that have shown that it is very difficult to recruit and retain study volunteers because they don’t have that relationship with the site study staff. ClinEdge can play an invaluable role in helping sponsors engage study sites more effectively and efficiently to be more successful. That is probably one of the most essential areas in the whole patient-centricity movement. We need better performing sites and sites whose success is supported so that patients can have the most positive experience in a clinical trial. I applaud what ClinEdge is doing in building a network of better sites.
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STATS Joined ClinEdge: 2013 Location: Boston Office Title: Associate Director of Business Development Education: Studied Business and Marketing at the University of New Hampshire Received her Master’s in Public Health at Boston University
Employee Spotlight:
Lauren Fopiano Lauren Fopiano began her career at ClinEdge back in 2013. She believed working for ClinEdge would be a great opportunity to combine her passion for the healthcare industry and her skills in business and marketing. Before working at ClinEdge she held various business-related positions within healthcare organizations and clinical research trials. What is an average day like for Lauren? There is no average day here at ClinEdge because there are always new projects. However, she would say her most typical day involves reaching out to potential clients, devising patient recruitment and marketing strategies, and working with the project management team to ensure existing client projects are running smoothly. Lauren oversees the proposal and strategy processes for patient recruitment and she regularly attends meetings with business development and marketing team members. What makes Lauren most excited to go to work? Her coworkers. It’s a great collaborative environment that allows everyone to pitch in on a project if needed. She has never felt like she couldn’t approach someone on a project, whether it’s for assistance or just general feedback. She enjoys how her coworkers
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have such different backgrounds. Joanne, her desk mate, was a pre-med major in college, whereas other employees’ backgrounds include everything from neuroscience to graphic design. This diversity in experience is extremely helpful when it comes to collecting information for and collaborating on projects. Lauren feels like the open floor plan in ClinEdge’s Boston office maximizes this collaborative environment. Not to mention, it makes it easier to share a funny story with coworkers! What is Lauren’s most memorable achievement at ClinEdge? Her most memorable experience has been pioneering the business development process for ClinEdge’s division of patient recruitment and marketing, ClinEdge Engage. Since she started in her current position, three additional employees have been added to the BD team to help support ClinEdge Engage. This team utilizes the process that Lauren helped set up. As the team grows, there have been changes to the process, but it’s been a great opportunity to watch the business develop.
How does she like being on the BD side of ClinEdge? She loves it! Lauren still uses her marketing background in terms of planning strategies when pitching different proposals and campaigns. Since ClinEdge is a smaller company, she can easily step back in to the marketing side of things by taking on additional marketing-related projects. She enjoys traveling to conferences and networking with colleagues, which is a big part of her position. Lauren likes that her role is so dynamic and that she has the opportunity to pursue her interests at ClinEdge. What is Lauren’s advice for people interested in getting into the Research and Development industry? Her main advice is that you shouldn’t be intimidated if you don’t have significant experience working in the industry. She thinks having people who come from different backgrounds is important to striving for change in clinical research. People sometimes overemphasize the importance of having hands-on experience in pharma or clinical research, but Lauren thinks having the passion and willingness to think outside the box is far more important. Having more business-minded people and creative-minded people definitely benefits the industry.
Lauren, a Boston native, loves to explore the city on the weekends with friends. She enjoys trying new restaurants, traveling, supporting animal rescue and walking her two rescue dogs!
Lauren, a Boston native, loves to explore the city on the weekends with friends. She enjoys trying new restaurants, traveling, supporting animal rescues and walking her two rescue dogs! When she retires she wants to be remembered for her passion and tenacity. She’s always been very committed to her career and things she cares about, which she believes translates into her work style. She also hopes to be remembered as someone who was always honest, fair, and willing to put others before herself.
Meet Vinny & Lulu, Lauren’s rescue dogs!
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An inside look into the process of branding a clinical trial. From sketches, to logos, to entire campaigns, the branding process is an extensive and exhaustive task. Check out what our design team has done.
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Our Creative Process
1. Brainstorm The first step in tackling any design project is brainstorming. Together we are able to come up with names, concepts, and various ideas by comparing our thoughts with our team members.
2. Sketch Ideas 3. Explore OPTIONS A typical logo design for a study will go through multiple rounds of revisions. We pride ourselves on being able to create exactly what our clients envision.
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Sketches are a great way for our team to translate our thoughts into tangible and thought-provoking designs. Through simple sketches our ideas have room to grow, especially on the computer screen.
4. Collateral Design Here at ClinEdge we take care in creating all aspects of the campaign, not just the study logo. A complete study brand is cohesive among all facets of the campaign. A study website, brochure and transit ads should all work together in one cohesive campaign.
5. COmpletion Once the final designs are complete and approved, we handle all the production and printing for a study. Once the materials are printed we distribute them wherever necessary. Additional materials can be printed per request.
See more of our creative portfolio
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Our Portfolio:
WEBSITES built for ultimate compatibility.
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COHESIVE Campaigns Our branded campaigns feature cohesive pieces designed to catch attention. The ClinEdge Engage marketing and design team is able to brand a trial from start to finish, starting with logo designs and content creation, all the way to completion and printing.
through Advancing medicine . clinical research trials future Improving the lives of generations.
Our greatest asset: Our
People.
Research’s team of Segal Institute for Clinical and Gynecologists Psychiatrists, Neurologists, ares of psychiatry, conduct studies for most and addiction. neurology, women’s health and grave these conditions We understand how sing in nature, they disorders can be. All-encompas why our people are so can destroy lives. That’s treatments and innovative committed to finding staff are among the new medications. Segal field. their leaders in
We are currently enrolling including : BACTERIAL VAGINOSIS BIRTH CONTROL COLD SORE DEPRESSION FIBROMYALGIA GAD
for a variety of studies
HOT FLASHES HEAVY VAGINAL BLEEDING MEMORY LOSS MIGRAINES OPIOID DEPENDENCE SCHIZOPHRENIA
Quality collateral
tailored to your audience.
Our design team creates cutting-edge posters, brochures, flyers, direct mailers, and any other collateral your site may need. Our designs can help you stand out among competitors, increase business, and create a cohesive brand for your study or site.
Visit Us at www.clin-edge.COM to see more! 28
THE RISE OF WEB DESIGN 2003
2004
2005
2006
778.5 million people have internet access
Facebook launches
6.6 billion minutes spent on social networking sites
Only 3.2% of mobile users own smartphones
PERCENTAGE OF AMERICANS WITH MOBILE DEVICES E-readers
32%
Tablets
42%
Laptops
Smartphones
52%
64%
HOW RESPONSIVE DESIGN REWARDS YOUr WEBSITE Mobile web use has surpassed desktop use, so reaching your mobile client base is no longer optional, it’s essential. In fact, Google is now rewarding sites with responsive web design by bumping up their search results rankings.
Companies that had their website designed for mobile saw a 62% increase in conversions.
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52% of users said that a bad mobile experience made them less likely to interact with a company.
48% of users said that if a site didn’t work well on their smartphones, it made them feel like the company didn’t care about their business.
2007
2009
30 million Americans connect to the Internet on a mobile device
Social networks and online blogs surpass all other online destinations
2008
On a daily average, Americans viewed 1hr50m worth of web video content
2011
2013
64% of time using mobile phones is spent on apps
2010
2012
2014
Morgan Stanley analysts predict web use to overtake desktop use by 2015
465 million active Twitter accounts worldwide
Mobile web use surpasses desktop web use for the first time in history
HOW CONSUMERS ARE USING THE WEB ON MOBILE DEVICES READING
2015
15%
Today, over 3 billion people have access to the internet. That’s over 40% of the world population!
SHOPPING 15% DOWNLOAD/USE APPS
41.7%
GAMING MUSIC EMAIL ACCESS INTERNET
Nearly 200 million tablets were sold in 2013 alone
46% 49.2% 62.1% 63.1%
ACCESS CONTENT/INFORMATION
MORE THAN HALF OF SMALL BUSINESS DO NOT HAVE WEBSITES
99.5%
SOURCES: 1. http://www.internetlivestats.com/ internet-users/ 2. http://searchenginewatch.com/sew/ opinion/2353616/mobile-now-exceedspc-the-biggest-shift-since-the-internetbegan
55% of small businesses are without websites. The two leading claims for not having a website are that it would take them too much time and money to create.
3. http://www.smartinsights.com/ mobile-marketing/mobile-marketinganalytics/mobile-marketing-statistics/ 4. http://www.inc.com/associatedpress/small-businesses-have-nowebsite.html 5. http://www.kunocreative.com/blog/ responsive-website-design-higherconversion-rates 6. http://trendyminds.com/blog/ article/talking-shop/using-responsiveweb-design-to-improve-customersatisfaction/
However, small businesses with websites have experienced a boost in sales, brought more people into their business, and reduced the amount of time spent on phone calls that a website could have handled.
7. http://blog.marginmedia.com.au/ Our-Blog/bid/87385/10-Mobile-WebDesign-Statistics-All-MarketersShould-Know-About 8. http://localvox.com/resources/ small-business-marketing-statistics/
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THE EDGE • SUMMER 2015 www.clin-edge.com 137A Lewis Wharf Boston, MA 02110