ClinEdge - The EDGE Magazine

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THE

EDGE pr

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Recruited over 100 patients in just 2 weeks for an osteoarthritis campaign, pg. 38 Pioneering a new patient portal, pg. 74

SEE OUR WORK INSIDE: THERAPEUTIC AREA ALIGNED PORTFOLIO // MARKETING AND PATIENT RECRUITMENT TACTICS // INTRODUCING BLUETHEORY CLINICAL TRIALS & MORE


48 Have you or your child been diagnosed with a

Primary Immune Deficiency? (PID) Find out more about a clinical study

34

IMMUNOe is conducting a clinical research study of an investigational drug for Primary Immune Deficiency (PID).

WHO CAN PARTICIPATE IN THIS STUDY? 2 years of age or older

INTERNATIONAL HEALTH & RESEARCH CENTERS

Diagnosed with a primary immune deficiency condition

Currently receiving IgG therapy

IF QUALIFIED, YOU CAN BE COMPENSATED UP TO $$.

74

Insurance is not required and there is no cost to participate

303-771-9000 $ $

www.IMMUNOeResearch.com

SOURCES

4 http://www.brandwatch.com/2012/12/how-we-use-social-highlights-from-the-social-media-report-2012/ http://www.seguetech.com/blog/2012/12/19/where-do-you-find-health-information-internet-course http://www.fathomdelivers.com/13-stats-every-healthcare-marketer-should-know-in-2013-and-why/ http://www.healthcaresuccess.com/articles/six-ways-market.html http://www.smashingmagazine.com/2009/02/03/clear-and-effective-communication-in-web-design/ Harris Interactive, 2005 National Survey in Sept 2012

26 National Survey by the Pew Research Center’s Internet & American Life Project: http://pewinternet.org/Commentary/2011/November/Pew-Internet-Health.aspx http://www.hschange.com/CONTENT/1260/ http://thechart.blogs.cnn.com/2011/03/04/patients-use-facebook-twitter-to-get-health-information/ Beasely, “Recruiting”. 2006 www.ciscrp.org Getz, Philadelphia Survey


Contents 2 4 6 8

Who we are Marketing Business Development Tier One Sites

Therapeutic areas portfolio 10 14 18 22 26 30 34 38 44 48 52 58 62 66 70

Cardiology Dermatology Endocrine/Metabolic Gastrointestinal Infectious Disease Neurology Ophthalmology Pain/Inflammation Psychiatry Pediatrics Respiratory Systems Sleep Urinary Symptoms Vaccines Women’s Health

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BlueTheory Clinical Trials


Who We Are ClinEdge is a business development and marketing company dedicated to the success of clinical trials.

2


BUSINESS DEVELOPMENT

MARKETING

ClinEdge represents a network of experienced, highly-qualified research sites. Through our established relationships with Sponsors and CROs, ClinEdge assists our network of independently-owned sites in developing a strong pipeline of study opportunities. At no cost to the sponsor or CRO, ClinEdge presents adept PIs/Sites which best fit the qualifications for each study. Utilizing ClinEdge’s established network accelerates the site selection process & ultimately amplifies the success of clinical trials.

ClinEdge’s marketing team offers a range of branding, traditional / interactive marketing, and patient engagement services. Our evocative marketing techniques are designed to increase patient engagement and market presence, while enabling site staff to remain focused on what matters most: excellence in research and patient care.


Marketing // Patient Engagement The Challenges and Bottleneck of Clinical Research Delays in patient recruitment result in an average of over four months lost per trial.

$ $

For the average company, a cumulative loss of 26 years is attributed to such delays.

We create new interest and enthusiasm for participation in clinical trials. For us, the standard participant profiles--those who are very sick and those who want to make money--are just the beginning. Our outreach goes much further than that.

Consumer engagement The clinical research industry is a fast changing business environment. Marketers need to rapidly identify and react to new growth opportunities.

4

>100%

>70%

>50%

increase in driving YouTube traffic directly to the hospital sites.

of patients used search prior to booking an appointment.

of healthcare marketers use blogs (vs. 74% of all marketers).

90%

>80%

>50%

of adults aged 18-24 value social media and the influence of their social network.

of people click on a sponsored link when looking for health information.

of people say they’d feel more valued as a patient when multiple channels are used to reach out to them, e.g. mobile, email, and blog.


fusing science and creativity Our Services

Integrated marketing campaigns specific to patient recruitment and retention.

The ClinEdge marketing and patient recruitment team can analyze your protocol and identify key enrollment barriers before they become a problem. We leverage our operational strengths on a site-by-site basis to achieve the most effective enrollment success.

50% of clinical research sites enroll one or no patients in their studies

< 5% of Americans know where to find info about clinical trials.

Increase patient engagement and market presence Increase overall impact on the medical industry

Advertising

Branding

Reach out to new prospective patients. Through media buys, radio/ tv, traditional print ads and more we design, launch and manage.

STAND OUT from the crowd. Express meaningful and effective messages at the right time.

Public Relations & Community Outreach

Graphic Design

Generate healthcare publicity. This tactic requires careful planning, good timing, and a clear message.

75% of the general public state they have little to no knowledge about clinical research and the participation process.

Our services help direct potential patients to clinical study opportunities.

Effectively merge images, words, and ideas to convey information to an audience.

Online Marketing

Internal Marketing

Build personable relations with prospects and patients via regular low-cost communication. Websites, social media tools, mobile apps.

Communicate with people who already know you, mainly current and previous patients.

Web Design, Development & Management Interactive and search engine optimized. Communicate clear and effective information through valuable content and appealing design.

Newsletter Marketing Reach a target audience through cost effective and highly successful newsletter campaigns.

What is a “Landing Page” anyway? “A landing page can be defined as a single web page a potential customer arrives at after expressing interest in one of your online ads.”

Why do we use them? The goal of a landing page is to quickly convey brief study details and prompt users to submit their information in order to be contacted by site staff.

1.

3.

You don’t have much time to capture the attention of a potential patient. A landing page streamlines the information submission process, and to add, they are cost effective!

2.

A brief form with limited fields won’t overwhelm users looking to submit their contact information. It’s quick, to the point, and takes only seconds to complete.

Bold graphics and headlines capture the attention of the user and display only the most important information

4.

Who wants to submit personal information through an untrustworthy or unbranded page? A branded, welldesigned layout adds to the credibility of the page and captures users attention quickly.


Business Development ClinEdge 2013 Quarterly Progress ClinEdge represents an elite multispecialty network of research sites across the United States and Canada. By leveraging our relationships and Business Development strengths we are able to offer our sites a large number of study opportunities.

Expediting the Site Selection Our Pipeline Strategy: Thorough Vetting Process and Assessment ClinEdge connects sponsors and CROs with highly-qualified sites. Check out the diagram on the right for more details.

279

101

Total study opportunities in Q1 2013

Study opportunities that came from CRO/Sponsor partnerships in Q1 2013

-

We see a minimum of one new study lead per day.

-

Each site within our network has been awarded a minimum of two studies per quarter.

-

Some of the multi-therapeutic sites in our network have been awarded upwards of six studies in a two month period.

This is a 15% increase from Q4 2012

The ClinEdge network sites have achieved their patient recruitment goals on Our average site has been awarded four study opportunities in Q1 2013

93% of the clinical studies completed in Q1 2013

Two of our sites received seven awarded study opportunities in Q1 2013 6


your reputation is our reputation

Studies

Sponsor/CRO and ClinEdge discuss available study material (blinded synopsis or protocol where applicable).

Selection

Sites that may be a good fit for the study are selected using the ClinEdge Site Matching Process. Criteria for the ClinEdge Site Matching Process includes, but is not limited to: PI experience, patient population, site equipment, and marketing strategy.

Consideration

A list of potential sites is submitted to the Sponsor/CRO contact via phone or email for consideration.

Documents

Review

Completion

Sponsor/CRO sends documents directly to ClinEdge network site. Site acts as main point of contact, OR Sponsor/CRO sends documents to ClinEdge for distribution. ClinEdge acts as main point of contact for proposed sites.

Site candidates review information. ClinEdge discusses trial needs with site representatives and ensures all questions are addressed before feasibility is completed.

Site sends completed documents to ClinEdge before designated deadlines. The information is reviewed and then forwarded to Sponsor/CRO. Any other requested information is available to the sponsor through ClinEdge, including: CVs, enrollment metrics, and site equipment.

Communication

Contracting

Recruitment

ClinEdge continues to monitor communication with sponsor and site until study is either awarded or unawarded.

Research Sites individually manage contracting and budgeting.

ClinEdge assists sites in patient recruitment if necessary.


Our Tier One Sites Within our network of sites, ClinEdge is proud to introduce and spotlight our therapeutic-specific Tier One sites. All sites within the ClinEdge network are

By categorizing top tier sites based upon

held to rigorous standards of excellence.

therapeutic area, ClinEdge will be able to

Each adhere to strict SOPs and regulations

provide site qualification details prior to

designed to uphold consistent and

receiving study information.

successful study execution. Our sites’ SOPs and operations are listed in more detail to

For each indication, we will be able to

the right. In order to further streamline the

immediately produce data for each Tier One

site selection process, ClinEdge will now be

site, such as:

offering a “Tier One” grouping of sites for each therapeutic area. Tier One sites

PI and Site location

are guaranteed to be the top performers

Specialty

within the noted therapeutic area. The Tier

PI years of experience

Study experience within specified therapeutic area

Size of patient database

Patient demographics

Type of site

Although all ClinEdge network sites have

Competing studies

been selected based upon their proven

Site capabilities/ equipment

One label is determined on an indicationspecific basis and denotes sites within our network that have extensive experience and continued success within the specified therapeutic indication.

abilities, the Tier One sites achieve this elite status by consistently exceeding study goals and timelines. The Tier One label describes the sites that consistently go above and beyond during the entire study process, and come with ClinEdge’s highest recommendations.

The Tier One sites are thoroughly vetted. We hope adding this status level will highlight the rigorous standards of ClinEdge, and the clinical research facilities we proudly represent.

8


ClinEdge represents a network of highly-qualified clinical research sites across a variety of therapeutic specialties. Each site within our network is carefully vetted and must adhere to strict quality standards. Through this rigorous vetting process, ClinEdge is able to ensure that each and every site within our network guarantees the following:

Minimum of three trained study coordinators Successful 483 response letter or improvement Dedicated regulatory document specialists at each site

Onsite Clia Waived lab Ability to conduct PK draws and access to daily dry ice Extra space for long PK visits (A Majority of our sites) Backup Generators

Startup regulatory documents completed within five days Patient recruiters at each site QA program in place at each site

Double locked drug rooms, Onsite refrigerated centrifuge, ambient centrifuge, -20 freezer, -70 freezer Onsite diagnostic equipment, or local relationship

Electronic Data Entry Capabilities Emphasis on investigator and coordinator training Ability to use central IRB

Yearly collaborations of all equipment, and collaboration records kept on site Daily temp. recording of ambient drug room, lab fridge, and all freezers. Triggered to alarm upon excursions

Detailed site SOPs Contracts/budgets turn within 3 business days PIs maintain a minimum 30 hours of trial oversight per week, and have a detailed SOP regarding P.I. oversight

Documented training documents for all research staff Sufficient Insurance Limits for professional liability, general liability, and malpractice


Due to the abundance of currently available cardiovascular treatments and medications, finding patients willing to participate in a trial that may require a cessation of previous treatments can be difficult. Using online recruitment tactics allows ClinEdge’s team to directly target patients who fit a specific treatment profile. This method decreases the screen fail rate and increases the return on investment for recruitment budgets. Additionally, employing newsletters to patient databases is a cost-effective method for targeting patients who are more willing to participate in trials. The ClinEdge recruitment team has noted a 32% conversion rate through newsletter outreach. 10


cardiology


12

CARDIOLOGY


1.

Landing Pages

ACUTE CORONARY SYNDROME CAD ATRIAL FIBRILLATION ANGINA PECTORIS ANGIOPLASTY HEART FAILURE HYPERTENSION ClinEdge creates a branded landing page for each online campaign. These landing pages are used to quickly convey the most important facts about a study and capture potential patient information. The most successful landing pages use simple and user-friendly design and content.

HYPERLIPIDEMIA HYPERCHOLESTEROLEMIA MYOCARDIAL INFARCTION PAD, PVD



DEERMATOLOGY Surprisingly, one of the most difficult audiences for recruitment is young men 18 to 21 years old窶田ausing acne trials possible delays in recruitment. Success can be found by engaging this audience in a precise targeted manner, such as through universities, online advertising, ESPN radio, etc.


DERMATOLOGY

HE LP FI G HT FA CI AL AC N E!

Are you between the d re e th o b d n a 0 4 & ages of 12 by

ACNE?

study, cipating in a research rti pa is ch ar se Re l stigational If so, Omega Medica edication versus inve m l ca pi to d te ke ar m comparing a t of acne. ebo for the treatmen ac pl to d re pa m co l topical ge 16

-739-3573

ll at: 401 fo please give us a ca

1.

Landing Page


IMMUNOE HEALTH Physician Office Poster

CENTERS

2.

1. Friendly faces on ads can ensure a relatable and approachable feel that patients will be more receptive to.

IMMUNOe Welcomes Dr. Marc Serota IMMUNOe will be adding a new service to their clinic this March. Dr. Serota who specializes in Dermatology will begin practicing on March 4th 2013. Originally from Long Island, NY, Dr. Serota attended the accelerated 6 year combined B.A//M.D. medical school program at the University of MissouriKansas City. He then completed his Pediatrics Residency at Cohen’s Children’s Hospital on Long Island and his Allergy/Immunology Fellowship at Children’s Mercy Hospital in Kansas City, MO. He holds board certifications in both Pediatrics and Allergy/ Immunology. In addition he has a strong interest in Dermatology and is currently completing a second residency in Dermatology at the University of Colorado Denver. As one of the only Physicians in the United States with training in both these specialties, he is very excited to be able to combine these two backgrounds to give patients the best possible diagnostic and treatment options for both allergic and dermatologic conditions. In his spare time he loves playing soccer, performing magic and traveling. I treat the following dermatologic conditions in pediatric and adult patients:

Specialty: Dermatology Location: Centennial

• Skin Cancer

• Moles

• Rashes • Psoriasis • Eczema • Warts

• Acne • Rosacea • Dermatitis • Vitiligo

Please call our office to schedule an appointment:

3. Direct mailer postcards are a cost-effective way to recruit patients from a site’s database, especially for studies recruiting an older population. This landing page features background imagery that relates to the indication without being too graphic. For studies that involve potentially unattractive indications, choosing appropriately sensitive images is important.

303-773-9000

• Concerns regarding growths • Concerns regarding cysts

Living with scaly age spots

on your face or scalp?

ACNE

Contact Omega Medical Research to learn if you may qualify for a clinical research study examining a topical cream treatment. Contact Omega Medical Research to learn if you may qualify for a clinical research study examining an investigational topical cream.

Adults experience actinic keratosis (age spots) may qualify. There is no cost to qualified subjects, and you may be reimbursed for time and travel.

ALOPECIA ATOPIC DERMATITIS DERMATITIS HEAD LICE IMPETIGO ROSACEA

3. Mailer

PSORIASIS WRINKLES


endocrinology


Although it may seem counter intuitive, we have found that internists are able to recruit patients for Type II Diabetes studies better than many endocrinologists. Therefore, many of our Type II Diabetes recruitment campaigns are internist-focused and utilize physician outreach. Capitalizing on expert knowledge has assisted ClinEdge’s patient recruitment team in recruiting more than 200 patients for six recent Type II Diabetes trials.


ENDOCRINOLOGY

1.

Mailer

Do you have Type 2

Diabetes?

Find out about a clinical re search study

You may be eligible to part icipate in a clinical research trial of an investiga tional medication.

20


LEARNING ABOUT

2.

Newsletter

Diabetes WHAT IS DIABETES? Diabetes is a medical condition in which the body is unable to properly process or produce insulin, a hormone required in order to effectively convert food into energy. Diabetes is the seventh leading cause of death within the United States, and can cause serious health complications such as heart disease, blindness, kidney failure, and diabetic neuropathy. Fortunately, the condition can be managed through blood sugar control, lifestyle modifications, and medication.

WE CAN HELP

QUICK FACTS

KRK Medical Research’s team of dedicated and caring medical professionals is committed to researching new treatment options for individuals with diabetes. For over ten years, we have given patients the opportunity to participate in the latest medical studies in a professional and comfortable environment. To learn more about ongoing diabetes studies, call or email one of our patient specialists.

In the U.S. alone, a new case of diabetes is diagnosed every 30 seconds; more than 1.6 million people are diagnosed each year.

2. Diabetes requires constant management and care. Diabetic patients are one of the most active patient populations when it comes to seeking health management information. Providing diabetes care and management tips is a great way to engage with patients on a personal level, and build report by sharing expertise. Newsletters and flyers proving health tips are a proven tactic for engaging with potential patients and presenting new studies in an appealing light.

Diabetes currently affects over 285 million people worldwide and is expected to affect 435 million by 2030.

TALK TO US Toll Free: 1-888-KRK-TODAY Local: (972) 907-1333 Fax: (972) 907-1336 Info@KRKMedicalResearch.com

Warning signs of diabetes include frequent urination, unusual thirst, extreme hunger, unusual weight loss, extreme fatigue, blurred vision, and tingling or numbness in the limbs.

6750 Hillcrest Plaza Dr. Suite 215 Dallas, TX 75230

DIABETES MELLITUS LIPID DISORDERS TRIGLYCERIDES OBESITY DIABETIC FOOT ULCERS

3.

Landing Pages

GROWTH HORMONES HYPOGONADISM


60 to 70 million people affected by all digestive diseases


Gastrointestinal Overall, Crohn’s Disease studies are arguably one of the toughest GI indications in terms of patient recruitment. Recruitment campaigns must target potential patients, as well as physicians who are particularly devoted to and enthusiastic about helping advance medicine. Site selection is critical in these studies. It takes the right site to find the right patient.


GASTROINTESTINAL

1.

24

Landing Pages


The use of arrows and directional shapes help subtly direct a user’s eyes to the information submission portal. Subtle design elements that refocus attention on the submission portal are shown to increase conversion rates and result in a higher volume of leads.

Newsletter Want to help us

May 2013

advance medical research?

ABOUT BEACON PHYSICIANS OUR OFFICE SPONSORS

Sign up for a study today!

ENROLL NOW

CURRENT / UPCOMING STUDIES

Article title here

Chronic Lower Back Pain Diabetic Neuropathy, DPN

Throughout the past ten years Beacon Clinical

Gout

Research has conducted clinical trials for pharmaceu-

Irritable Bowel Syndrome, IBS

tical companies such as Abbott, Amgen, GSK, Merck,

Shingles (PHN)

Pfizer and others. Beacon aims to enroll high numbers of eligible, compliant subjects, while generating

Constipation

and maintaining high quality source documentation

Fibromyalgia

and entered into EDC within 24- 48 hours. Beacon

Osteoarthritis of the Knee

Clinical maintains continual diligence and compliance

Opioid Induced Constipation, OIC

of GCP Guidelines, an important factor in both patient

High Cholesterol

safety and industry standards. Throughout each trial,

High Blood Pressure

Beacon ensures it provides full execution of protocol with complete and accurate data. The site has established long-term relationships with multiple pharmaceutical companies and CROs. Beacon Clinical Research is conveniently located in Brockon, MA, a racially diverse community about 30 minutes south of Logan Airport.

Beacon Clinical Research is a multi-specialty clinical research facility specializing in Phase I-IV clinical trials. In 2000, Beacon Clinical Research was established to offer patients the opportunity to enroll in clinical pharmaceutical trials. Participants are significant in contributing to the development of new innovative medications. Study participation potentially benefits the individual patient and contributes to the advancement of health care in our society.

Call us at: 508.584.2030 ext.210 Email: info@BeaconClinical.com Visit: www.BeaconClinical.com

ANAL FISSURES CONSTIPATION CROHN’S DISEASE

2.

Newsletter

DIARRHEA NAUSEA

{ WE HAVE SEEN AN AVERAGE 32.03% CONVERSION RATE FOR NEWSLETTER CAMPAIGNS}

HEMORRHOIDS GERD, IBS, ULCERS, UC OPIOID INDUCED BOWEL DYSFUNCTION




INFECTIOUS DISEASE

April is STD Awareness Month

April 2013

Each year in the United States, there are 20 million new cases of sexually-transmitted disease (STDs) resulting in $16 billion in annual treatment costs. What's the best way to reduce these numbers? Education. Knowing how to prevent, recognize, and treat STDs is the best way to keep yourself and your community healthy. The goal of STD Awareness Month is to educate and increase the visibility of STD facts, treatments, and risks. Take control of your health and protect yourself against STDs. Effective methods of STD prevention include vaccination, abstinence, mutual monogamy, and condoms. Knowing your STD status is another critical part of reducing the spread of disease. Make sure you and your partner are tested. Ask your doctor to make sure you are getting the right tests. Certain STDs are not always accompanied by observable symptoms, and regular testing can prevent the progression of undetected diseases. Many STDs can be treated with early detection, so regular testing is a key part of staying healthy. Know the facts and stay healthy! Continued...

28

1.

Newsletter


Capitalizing on public awareness campaigns is a great way to increase the visibility of infectious disease studies. Certain indications are also best recruited using materials without graphic imagery. Creating appealing imagery is important, as potential patients can be turned off by unpleasant visuals.

STD/PA P Testing

Subjects: • Must be females only • Age 16 and over

(17 years of age and under need to have parent at visit)

• Provide urine sample, Pap test and vaginal swabs Screening Site: 1065 NE 125 Street, Suite 219 North Miami, FL 33161

• One day study visit conducted by BoardCertified Gyneco logist • Confidential Chlamydia, Gonorrhea and Trichomonas • Pap test pro vided at no cost for subjects 21 and older • $50 after visit is completed All info rmation in conf idential!

Code#___________

COMMON COLD HERPES GENITAL WARTS CABP CSSSI INFLUENZA HCV, HIV, STDS

2.

News Graphic

ONYCHOMYCOSIS MENINGITIS TINEA PEDIS


S

Neurolog Regarding studies and new treatments for Alzheimer’s disease, we determined that recruitment efforts should not only motivate patients, but also their caregivers and families. Since Alzheimer’s affects the life of the patient, and his or her entire family, our campaigns address the full spectrum of practical and emotional concerns for caregivers, families and patients.


gy


NEUROLOGY

1.

Landing Page

2. Social Media Graphics

3. Event Invitation

32


Suffering from

relapsing remitting multiple sclerosis? WHO CAN PARTICIPATE IN THIS STUDY?

• Must have relapsing remitting MS diagnosis • Be 18-55 years of age • One relapse within 12 months , but relapse free within two months prior to randomization If qualified, You can be compensated up to $1,320 for your time and trave l. Insurance is not required and there is no cost to participate

4. Study Posters INTERN ATION AL HEALT H & RESEA RCH CENTE RS

Contact IMMUNOe today to see if you may qualify for this clinical research study

303.771.9000

IMMUNOeResearch.com

1. Color choice is also an important part of landing page design. Using a splash of red across a primarily white background will catch user’s eyes and help a landing page stand out amongst a sea of competing pages. Red is also commonly associated with pain, thus reflecting the pain of migraines. 2. Displaying posters within waiting rooms, local clinics, and doctor’s offices can be a cost-effective way to promote a study to patients already actively seeking treatment. Highlighting aspects of the investigational treatment that may appeal to patients (such as a new investigational tablet to replace an injection, or an investigational treatment that may have fewer side effects) will elicit a stronger response across the most qualified potential patients. 3. Planning educational events can be a great way to promote a study and cultivate credibility within your community. Dinner presentations are a personal way to educate physicians and potential patients as to the potential benefits of a study treatment. Events are most successful for studies that rely heavily on physician referrals, or target populations for whom effective treatments are limited.

ALZHEIMER’S DISEASE DIABETIC NEUROPATHY EPILEPSY PARKINSON’S DISEASE MULTIPLE SCLEROSIS MIGRAINE, HEADACHE PERIPHERAL NEUROPATHIC PAIN


OPHTHALMOLOGY


One of the key tactics we used to get enrollment back on the right track for a Diabetic Macular Edema (DME) study was developing a message that resonated with this patient population. “Tablet for DME� was a branded phrase that sparked interest in the study and prompted potential participants to learn more about a novel oral treatment option. As of today, the only approved drugs on the market for DME are injections.


OPHTHALMOLOGY

2. Appointment Cards

1. Logo

3. Brochure

5. 4. Decal

Tablet Medication for Diabetic Eye Disease

36

Mailer


ClinEdge’s centralized campaigns are uniquely customizable and branded. ClinEdge’s marketing team created a comprehensive centralized package, while working with each site to determine what tactics will be most effective in their area. Sites appreciate the ability to choose recruitment tactics, as well as the ability to focus on conducting a successful study while ClinEdge handles the recruitment!

6. Website

7. Poster

MACULAR DEGENERATION OCULAR HYPERTENSION DRY EYE DIABETIC EDEMA UVEITIS CATARACTS



N I A P ClinEdge recently was tasked with selecting sites and recruiting for a 320 patient Osteoarthritis of the knee study. This study was far from ordinary, and included extremely aggressive study start up and recruitment timelines. ClinEdge handpicked nine sites to recruit these patients in just two weeks. Our centralized campaign focused on the prep-work, prescreening and scheduling of patients prior to the start of the study. Our recruitment campaign referred over 100 patients in just two weeks. [reference page 42]


PAIN

1. Landing Pages

40


ACUTE PAIN BACK PAIN CHRONIC PAIN LUPUS FIBROMYALGIA OSTEOPOROSIS

2. Social Media Graphics

OSTEOARTHRITIS POST HERPETIC NEURALGIA FIBROMYALGIA TENDONITIS

1. Pain studies recruit well through online and television advertisements, as many patients suffering with chronic pain are homebound.

2. In addition to creating traditional recruitment materials such as posters and brochures, ClinEdge also creates websites for each centralized campaign. This website provides more in-depth study information and is a great resource for potential patients.

NECK PAIN NEUROPATHIC PAIN GOUT BURSITIS


PAIN

2. Poster

3. Website

42


{ AVERAGE OF 18 LEADS PER ONLINE PAIN CAMPAIGN } 4. Online Ads

6. Contact Card 5. Brochure

Each centralized campaign is given a unique and memorable brand, which creates cohesion across all advertisements.


ps

r y t a i h c y


W

e devote a large percentage of our recruitment dollars to online advertising for a Major Depression Campaign. Most depressed patients tend to browse the internet in search of solutions. Through our online campaigns, we have successfully recruited an average of 20 potential patients for each depression study.


PSYCHIATRY

1.

2. Poster

46

Brochure


Sites that distribute monthly newsletters to their patient database can see a 30% conversion rate on each newsletter sent. This conversion rate equates to 10-30 new leads each month (depending on database size) acquired at no cost!

Depression & the Holidays: Tips for Coping As the holiday season approaches, feelings of festive cheer can be

3. Poster

November, 2012 NEW STUDIES N OW E N R O L L I N G • ADHD (adolescents) • Bacterial Vaginosis

accompanied by feelings of

• Binge Eating Disorder

stress and depression. The

• Birth Control Gel

stress of holiday demands— parties, gifts, decorating, cooking, yikes!—coupled with the pressure to spend the holidays with loved ones, can be overwhelming. The coping tips listed below can help lessen the potential impact of holiday depression. Especially if you have experienced depression in the past, be aware of signs of depression and seek help if necessary.

Coping Tips: Acknowledge your feelings. It’s okay to take time to be sad, cry, and express your sadness. Forcing yourself to be happy won’t help, and ignoring depression may even prolong its symptoms. Reach out. If you’re feeling lonely or isolated, don’t hesitate to seek help through community, religious, social, or medical resources. Volunteering can be a great way to spend time with others and help a good cause. Be realistic. The holidays aren’t perfect. Focusing on perfection can lead to disappointment. Instead, enjoy the happy moments and

• Bipolar Depression • Bipolar Disorder (adolescents & adults) • Chronic Pain Due to Postherpetic Neuralgia (PHN) • Depression with sexual dysfunction • Depression • Endometriosis • Fibroid-related Anemia • Low Sex Drive • Low Back Pain • Opioid Induced Constipation • Acute Schizophrenia or Mania • Schizophrenia • Psychotic Disorders - ALL (Children & Adolescents) • Yeast Infection

VISIT:

celebrate the accomplishments of the past year. Continued...

ADHD ALCOHOLISM EATING DISORDERS OPIOID ADDICTION

4. Newsletter

OCD ANXIETY BIPOLAR DISEASE

{ AVERAGE OF 20 LEADS PER ONLINE PSYCHIATRY CAMPAIGN }

DEPRESSION SCHIZOPHRENIA SMOKING CESSATION


Pe diaT rIcs


As with many pediatric studies, they offer a challenge in recruitment, and Pediatric Type ll Diabetes is no exception. To meet the challenges of these studies, we purposefully use a multi-pronged approach in our initiatives to see success. Our tactics include utilizing Radio, TV advertising, as well as direct mail to homes, schools, and advocacy groups in neighboring communities. Efforts need to urge parents to consider screening for their children, and leverage access to expert care through study participation.


PEDIATRICS

Have you or your child been diagnosed with a

Primary Immune Deficiency? (PID) Find out more about a clinical study

IMMUNOe is conducting a clinical research study of an investigational drug for Primary Immune Deficiency (PID).

WHO CAN PARTICIPATE IN THIS STUDY? 2 years of age or older

INTERNATIONAL HEALTH & RESEARCH CENTERS

Diagnosed with a primary immune deficiency condition

Currently receiving IgG therapy

IF QUALIFIED, YOU CAN BE COMPENSATED UP TO $$. Insurance is not required and there is no cost to participate

303-771-9000

AB OU T US

www.IMMUNOeResearch.com

At 2. IMMU NOe we focus Brochure on your immune health IMMUNOe has been an international leader in conducting clinical research trials since 1992. With multiple sites within the United States, Central America and Europe, we conduct research studies for pharmaceutical companies and independent investigators seeking to gain valuable knowledge about

INTERN ATIONA L HEALTH & RESEAR CH CENTE RS

new compounds and treatment options.

PRIM ARY IMM UNE DEF ICIEN CY (PID )

Call: 303-771-9000 As within our clinical practice, we believe

www.IMMUNOeResearch.com the immune

system may be either directly or indirectly many disease processes. That is why we

involved in

have made it

our mission to conduct research that examines the most important, complex and compelling issues surrounding the full spectrum of immune related disorders. At each of

50

INTERN ATION AL HEALTH & RESEAR CH CENTE RS

6801 S. Yosemite St. Centennial, CO 80112

FIND OUT MORE ABOU T A CLINI CAL STUD Y.

1. Poster


3. Landing Page

Has your child been diagnosed with

Autism, Asperger’s, or Pervasive Developmental Disorder Not Otherwise Specified (PPD-NOS)?

Find out more about a clinical research study

Intern atIona l HealtH & resear cH center s

Your child may be eligible to participa te in a clinical research trial for an investiga tional drug.

Study Volunteers must meet the follow

Study Visits:

ing criteria:

6-12 years of age Child must meet the DSM-IV criteria for autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

50 week study including a 2 week screening.

Must have a knowledgeable caregiver capable of providing reliable information about the patient’s condition Other criteria apply

Participants must be willing to travel to the study site in Centennial, CO.

Costs:

There is no cost to participate. Patients who qualify will be compensated for time and travel.

CALL: 855-IMMUNOE (855-466-8663) EMAIL: research@immunoe.com

www .IMM UNOe .com

4. Brochure

5. Landing Page

1. Using printed advertisements, such as posters and brochures, throughout local pediatric offices and clinics is a costeffective way to target families of potential patients. Families are much more likely to consider participating in a study if referred by a trusted physician, so working with referring physicians to highlight the potential benefits of the study and communicate these benefits to patients is especially important. 2-4. Pediatric study recruitment materials must incorporate youthful imagery and colors while conveying a sense of security and minimal risk to the guardians of potential patients. Pediatric studies often recruit well through television and radio.


Patients with mild to moderate asthma have several available effective treatment options – inhalers, capsules, injections, and more. Patients want to participate in daily activities with a minimal amount of disease management interfering with their lives. This must be taken into consideration when developing an effective recruitment plan.



Is your child living with RESPIRATORY

year-round allergies? WHO CAN PARTICIPATE?

• 6–11 years of age - diagnosis of Perennial Allergic Rhinitis (PAR) for at least one year • 4–5 years of age - diagnosis of Perennial Allergic Rhinitis (PAR) for at least 6 months is sufficient

1. Poster

If qualified, You can be compensated for your time and travel. Insurance is not required and there is no cost to participate

IMMUNOe International Research Centers are conducting a study examining the realworld effectiveness of an investigational aerosol nasal spray for year-round allergies.

INTERNATIONAL HEALTH & RESEARCH CENTERS

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ALLERGIC RHINITIS

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ited

303.771.9000

QUICK FACTS ALLERGIC RHINITIS

INTERNATIONAL HEALTH & RESEARCH CENTERS

Allergic Rhinitis

INTERNATIONAL

HEALTH & RESEARCH

utical

CENTERS

ors

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IMMUNOeResearch.com

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6-11 years of age - diagnosis of Perennial Allergic Rhinitis (PAR) for at least one year 4-5 years of age - diagnosis of Perennial Allergic Rhinitis (PAR) for at least 6 months is sufficient 9 study visits 13-16 week study

303.771.9000

INTERNATIONAL

www.IMMUNOeResearch.com

CENTERS

HEALTH & RESEARCH

Please call Leah at 303-771-9000 ext. 1235

S. Yosemite St. 2. 6801Brochure

une

Centennial, CO 80112

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FIND OUT MORE ABOUT A CLINICAL STUDY.

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54

PA N A M A

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3. Quick Facts Reference Card


Many patients suffering with allergies or asthma are currently using prescription medications to treat their condition. Working with area pharmacists and placing study advertisements in area pharmacies, can help reach patients who may be looking for alternative treatment options.

ASTHMA ALLERGY COPD

4. Landing Pages

RHINITIS SINUSITIS

{ AVERAGE OF 15 LEADS PER ONLINE CAMPAIGN FOR ASTHMA/ALLERGY }

EMPHYSEMA BRONCHITIS CYSTIC FIBROSIS


RESPIRATORY 5. Website Study Video

6. Infographic

56


5. Incorporating videos into your website is a great way to capture patients’ attention and convey new information in an engaging format. Videos are versatile, and can be posted across a variety of online platforms including social media sites and blogs.

6. Infographics offer a creative alternative to presenting data in a chart or graph. ClinEdge is able to create custom infographics that include relevant health and clinical research information in an accessible and interesting format.



sleep For those who have trouble sleeping at night, many sleepless nights are spent either watching TV or browsing the internet, nothing works better to recruit patients than online advertising.


SLEEP

1. Landing Pages

60


Patients suffering sleep disorders are best targeted through online and television campaigns. Many potential patients who are able to sleep consistently spend late hours browsing the internet or watching television. Sleep study campaigns should be structured to catch these patients when they are most likely to be searching for new treatments.

INSOMNIA NARCOLEPSY SLEEP APNEA RESTLESS LEG SYNDROME SHIFT WORK SYNDROME


urinary s ystems



URINARY SYMPTOMS

WHEN

NATURE CALLS...too often You may be eligible to participate in a clinical research study for a new investigational therapy for Overactive Bladder

INTERNATIONAL HEALTH & RESEARCH CENTERS

Study Volunteers must meet the following criteria: Females between the ages of 40-75 years If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study History of overactive bladder symptoms for at least 3 months.

Costs:

Study Visits:

There is no cost to participate. Patients who qualify will be compensated for time and travel.

Participants must be willing to travel to the study site in Centennial, CO.

CALLS... E R U T A N N E H W303.771.9000 oo often

t

www.IMMUNOeResearch.com

1. Poster l pate in a clinica ible to partici y ig ap el er be th l ay na m You vestigatio y for a new in research stud e Bladder for Overactiv

2. Mailer

64


These online and poster tactics immediately capture the target audience by using imagery specific to the indication at hand. These campaigns also as deliver an eye-catching light-hearted message to individuals suffering from urinary complications.

3. Landing Page

ED INCONTINENCE OVERACTIVE BLADDER BPH UTI MALE FERTILITY INTERSTITIAL CYSTITIS


vaccines



VACCINES

1. Facebook Ad

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Vaccine trials often recruit healthy volunteers. Potential compensation, as well as a desire to contribute to healthcare research, are primary motivators for health volunteers. Highlighting these elements in recruitment materials will increase the success of recruitment tactics and generate more interested leads.

Are you a healthy adult between the ages of 18 and 40? Contact Omega Medical Research to learn if you may qualify for a clinical research trial examining a vaccine for smallpox disease. QualiďŹ ed participants may be compensated up to $575 for time and travel expenses. There is no cost to qualify, and insurance is not required. To learn if you may qualify, please contact Omega Medical Research:

omegastudies.com

401-739-3573

A clinical trial is un derw the safety and effect ay to test iveness of a new, in vestigatio nal Smallpox vaccine. Yo type of u have th option to e help med ical develop a vaccine fo research to r Smallpox .

Help us res

We need he al

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2. Mailer

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3. Poster


WOMEN’S HEALTH


Menopause can be potentially embarrassing for some woman. Creating appropriately sensitive marketing materials that encourage women to talk and discuss this condition is one of the many ways that can significantly boost recruitment.


1. Poster

72

WOMEN’S STUDIES


Many women’s health issues studies can be effectively recruited by working with women’s support groups. ClinEdge has worked with many clients in order to plan events and create materials to be distributed at women’s groups and health fairs. This proactive and hands-on approach not only helps recruit patients into your studies, but also helps build your reputation within the community.

2. Online Ad AMENORRHEA

3. Mailer

DYSMENORRHEA HPV

CALLS... E R U T A N N E WH oo often

t

BREAST PAIN CONTRACEPTION ENDOMETRIOSIS HRT OSTEOPOROSIS OVERACTIVE BLADDER HOT FLASH FEMALE SEXUAL DYSFUNCTION

l pate in a clinica igible to partici ational therapy You may be el ig st ve in y for a new research stud e Bladder iv ct ra ve O for

UTERINE DISORDERS VAGINAL ATROPHY VULVOVAGINITIS


74


Pioneering a new patient portal Coming July 2013! As patients become more active in managing their healthcare online, the tools that they access must be easy and effective. Blue Theory Clinical Trials is a website portal which allows patients to actively manage their health through local clinical research opportunities.

Study notifications that apply to you BlueTheory allows patients to browse studies in their area and set up a Patient Profile that will send relevant studies recruiting in your area to you based on communication preference. Members can browse studies based on location, health condition and other criteria. Your customized Patient Profile lets you save settings, indicate study focus, and connect with healthcare professionals in your area. The online forums also allow patients to correspond with each other on a variety of topics. Don’t forget to stop by our blog for health tips and clinical research news.

A customized experience BlueTheory groups trials by location—providing a quick and easy way for potential patients to browse trials in their area. Each city page will feature a comprehensive list of local studies in your area, which can then be filtered based upon indication and other criteria. Potential patients can also filter search results based upon their health care needs, thus allowing patients to play an active role in their care.

Please contact info@bluetheoryclinical.com to learn more


ClinEdge, LLC // The EDGE // Vol. 1 Issue 1 138/139 Lewis Wharf Boston, MA 02110 857.496.0054 // www.clin-edge.com


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