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MediciGlobal 2013

‘A Clear Partner’

‘A Clear Difference’

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MediciGlobal 2013

TABLE OF

CONTENTS 4

Introduction

6

Headstart to Recruitment

8

Leaky Pike

10 12 14 16 18 20 22 24 26 28 30 31 32 33

Case Studies: Major Depression Disorder Epilepsy Renal Anemia Partial Onset Epilepsy Alzheimer’s Disease Chronic Idiopatic Constipation Pediatric Sickle Cell Disease Interstitial Cystitis Pediatric Growth Hormone Skin Lupus Rheumatoid Arthritis Von Willebrand Disease Gout

35

Meet The Experts

39

Advocacy

40

Supersite Support

42

Access to Patients

44

Email Marketing

46

Patient Communities

48

Lost to Follow Up

50

Going Glocal


MediciGlobal 2013

USING AN ARRAY OF SUCCESSFUL RECRUITMENT TOOLS WE HAVE PERFECTED THE PATIENT RECRUITMENT PROCESS OF FINDING THE RIGHT PEOPLE FOR THE RIGHT STUDY.

US Office King of Prussia, PA, TEL : +1 484 674 6800 UK Office London, TEL : +44(0)20 8834 1447

www.PatientRecruitment.com

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Introduction MediciGlobal

WHERE OUR PEOPLE COUNT * INNOVATION NEVER STOPS AND OUR METRICS MAKE OUR PROGRAMS TRANSPARENT


MediciGlobal 2013

MediciGlobal is in the business of making a meaningful difference to patient health by identifying and engaging patients for clinical trials, and by building deep and lasting connections with our many stakeholders. Our clinical trial recruitment practices are guided by global standards and by our concern for the lives of the patients who put their trust in us. We’re also making certain that those who participate in these trials fully understand what clinical trial participation means, and that their participation is guarded by strict privacy policies. Headquartered in Philadelphia, USA and London, UK, MediciGlobal meets BBB OnLine® and WBENC accreditation standards and is certified as a Safe Harbor company. Visit www. mediciglobal.com and follow the company on Facebook at www.facebook.com/MediciGlobal.

THE PATIENT RECRUITMENT REVOLUTION

‘Patient recruitment has seen more change in the past 3 years than in the previous 20 years. Today we reach patients directly without a media filter. The speed of change is unprecedented’ Liz Moench, President & CEO MediciGlobal

In our niche area of clinical trials, change has been swift; driven by patients, technology, the internet, and changing health systems. We have rapidly adapted to this change. As leaders in the new eRecruitment environment, we have prepared this magazine to provide highlights of our achivements over the past six months. We aim to demonstrate how strongly we are positioned for continuous innovation through our people, our products, and our success. Strategic partnerships among CROs and sponsors, and niche providers are part of the new clinical development model today, and we welcome the opportunity to forge a deep and lasting connection with you.

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HEADSTART TO RECRUITMENT A GLOBAL DIRECT-TO-PATIENT APPROACH TO RECRUITMENT


MediciGlobal 2013

Today in clinical research the focus is on speed: Speed to initiate sites, speed to launch recruitment, speed to randomize patients and speed to complete the clinical trial on or ahead of schedule. But speed must be balanced with quality and this means enrolling the right patients; those most likely to be evaluable.

Through Head Start to Recruitment™ we know what it will take for patients to enroll in a study: Patient recruitment succeeds when all stakeholders know what it will take for patients to enroll. We do this by asking them. From patient advisory panels and eFocus Groups as part of our Head Start to Recruitment™ program, we rapidly gain feedback and insight from more patients than ever before, and through the Internet we can achieve this faster and cheaper as well. Through Head Start to Recruitment™ speed is balanced with quality. Our patient centric approach ensures rapid patient recruitment success. Head Start to Recruitment™ combines direct-to patient surveys, target marketing and an invitation to be considered for an upcoming clinical trial. Head Start to Recruitment™ sets our recruitment programs up for success on a country by country basis. Getting a Head Start to Recruitment™ Head Start to Recruitment™ combines essential planning and patient feasibility with early recruitment implementation. The result - we ensure recruitment success of quality patients with speed to completion. A focus on “evaluable patients” - We balance our focus on speed to recruit with a focus on quality and recruiting the right patients into our clients’ studies.

DYNAMIC PATIENT DATA BASES Importantly, Head Start to Recruitment™ offers unique advantages; • ‘Living database’ of specific patients interested in clinical trials identified in advance of study launch; our databases are current. They do not contain data that’s aging and no longer relevant. This is important since medical databases can date themselves rapidly. • Patients are located within the proximity of study sites, so the numbers you see are local not national on a country by country basis. • Patients have opted-in, so we have access to patient contact details. • Patients become part of patient advisory panels offering important insight throughout the study.

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MediciGlobal 2013

INBOUND CONTACTS

NON VIABLE CONTACTS

- Web terminates - Not interested in taking investigational product - Information only calls - Calling for someone else - Fact finding - Repeat contacts LE AB S VI CT N- TA NOON C

- Excluded medical conditions - Age/Gender exclusion - Protocol exclusion criteria

STUDY SITE FAIL TO FOLLOW UP

- Resource limitations (time and personnel) - Study competition at site - Site location - Site closure - Change in study staff

NG

I NE EN O RE PH E-C SS PR PA EB W

- XY%

PRE-SCREENER DISQUALIFIED CONTACTS

G

IN

RM

FO

R PE N NO TES SI

- XY%

- Further health history screening - Referral does not respond - Not responsive to contact - Referral does not schedule or postpones indefinitely - Investigator discretion

T

OW ISI SH V & NG LE NI DU EE HE CR SC R S FO

- XY%

SUBJECT FAIL

SCREEN FAIL

- Study specific Inclusion/Exclusion criteria not met. - Other baseline phase failure

M DO

N RA

- XY%

ED

IZ

Leaky Pipe is a forecasting tool that projects where and why the dropout will occur; the story of a subject’s journey in a clinical trial.

- XY%

- Declined Informed Consent - Problem with commitment to schedule E ET EN PL E M SCR CO TE SI

%

SCREENING VISITS


MediciGlobal 2013

The goal is to turn data into information, and information into insight. –Carly Fiorina, Former CEO of HP

LEAKY PIPE The Business Analytics team is responsible for the accuracy and report generation of project specific metrics. Each team member is assigned to a specific study and is responsible for compiling and normalizing data for use in the metrics package and leaky pipe. Their focus then shifts to the accurate portrayal of the study specific to both sites and sponsors via the use of interactive dashboards that are both created and updated by the team.

The Business Analytics team prides itself on being able to accurately provide perspective on the various stages of a study and benchmark future goals and targets. Doing this provides MediciGlobal with a starting point for study expectations, and gives us the opportunity to plan accurately based on data projections. The importance of this team is paramount in that it would be extremely difficult to predict future activity for a study without knowing history or having enough perspective to benchmark and set reasonable expectations. For these reasons, the Business Analytics team is very much the backbone of MediciGlobal.

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case studies


MediciGlobal 2013

Patient recruitment requires both direct marketing to reach patients using internet advertising and social media, as well as indirect marketing that involves the site kits, and reaching ‘organic patients in sites’ databases.

78%

SUPPORTING STUDY SITES

lift with the use of site kit materials on a global scale

Even in a shifting digital age for patient recruitment, study site kits are still a fundamental part of the recruitment process. Our site kits are based on the input from patients and from sites. Clinical trial sites like to choose which tools they want to use depending upon their environment. No two study sites are alike.

36%

Our award winning design team will create award winning designs. For global studies our site kits are glocal, global in branding and content, local in customization and implementation. The team can be assured that MediciGlobal will develop site kits that deliver a competitive advantage… they never sit on the shelf—they’re used—they deliver results!

lift with the use of site kit materials in the United States

B

APPRO

D

IRB

VE

IR

Our site support goes beyond site kits to supporting sites in a digital environment - from building site Facebook pages to promoting speaking event. We help study sites engage with patients.

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MediciGlobal 2013

RECRUITMENT GLOBAL SITE KIT: • Wall Posters • Study Brochure • Appointment Reminder Card • Informed Consent Flip Chart • Protocol • Study Protocol Cards

WEB

• Study Website • Thank You Card • Newspaper Ads

RETENTION SITE KIT: • Website • Retention Booklets • Birthday Cards • Thank You Cards

PRINT


MAJOR DEPRESSION DISORDER

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CASE STUDIES: 2012/13 project scope:

Develop a site kit and retention program for use in a global Depression study.

challenge

solution / result

• Develop a campaign across many cultures and customs in support of four global studies. • Find areas for synergy in material development across the 4 protocols involved in this global study.

• Developed a digital recruitment campaign with printed site kit that included Wall Posters, Brochures, Appointment Reminder Cards, Informed Consent Flip Charts, Mini Protocol Books and handy Inclusion/Exclusion criteria cards. Developed and executed a diverse Retention program focused on patient engagement. The program included study booklets for each site visit along with e-Newsletters, tokens of appreciation for patient study milestones, and a patient website with online resource library.

Up to 300 Study Sites in 15 Countries


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EPILEPSY

CASE STUDIES: 2012/13 project scope:

Recruitment and retention support to engage, educate, and retain patients in a challenging monotherapy study for patients with partial epilepsy who continued to have uncontrolled partial on-set seizures despite taking Antiepileptic Drugs (AEDs). Market research findings indicated that epileptic patients were afraid to titrate off their current AEDs to only the study medication.

solution

result

• MediciGlobal leveraged its very own Team Epilepsy, the largest online Epilepsy community, by providing IRB approved educational materials through social postings and targeted advertisments around study sites. Study related videos, PI and enrolled patient interviews, along with field-tested advertisments explained the inclusion and exclusion requirements associated with a monotherapy clinical trial, and ensured that all enrolled patients would receive the study medication.

• Overwhelming response to digital advertising with over 11,000 viable contacts • Over 85% site screens were MediciGlobal referrals • Team Epilepsy Facebook page ‘likes’ grew from 30,000 to 200K+ from project launch to close • MediciGlobal’s contributions of randomized patients saved the sponsor more than 6 months delay and approximately 8 million dollars.

MediciGlobal utilized digital marketing strategies to reach Recruitment Support: • Translated site kit materials (Spanish & French) • •

Team Epilepsy support at local/ national events Online video & photo contests to spread study awareness

the growing online epilepsy community: •

Hyper-targeted digital advertising for each study site individually

Mobile phone mini pre-screener

Customized micro-site (landing page) in conjunction with USA Today a major US newspaper that provided access to PI interviews, study information, epilepsy news and advocacy events


MediciGlobal 2013

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RECRUITMENT

SITE KIT: • Wall Poster / Flyer • Study Brochure • Study Visit Invitation • Appointment Reminder Card • Study website

PRINT

WEB


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RENAL ANEMIA

CASE STUDIES: 2012/13 project scope:

Develop study branding and recruitment site kit for a Phase II end-stage renal disease study.

challenge

solution / RESULT

• Raise the profile of the study site at dialysis treatment centers with well designed recruitment support aids. Site kit materials were designed for use by potential patients as well as physicians and staff in hemodialysis centers and hospitals. Physician-facing materials had to stand out against other studies’ materials that would be posted in staffonly areas of centers and hospitals.

• The site kits that included a brochure, wall poster, note pads and magnets with messaging for patients as well as a separate wall poster, Informed Consent Flip Chart, clip board and other materials were well received by physicians and medical staff resulting in meeting recruitment timelines.


MediciGlobal 2013

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RECRUITMENT

SITE KIT: • Wall Poster / Flyers • Study Brochure • Study Protocol • Study Flow Chart • Study Inclusion / Exclusion Chart • Radiology Punch Card • Informed Consent Flip Chart • Magnet / Pens / Pins / Clip Board

THE ACE 011 STUDY

PRINT


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PARTIAL ONSET EPILEPSY

CASE STUDIES: 2012/13 project scope:

MediciGlobal contribution centered on providing expertise, strategies and a customized recruitment for a 35-week recruitment campaign.

challenge

solution

result

• Challenging Protocol Design: an extremely high rate of drop out during pre-screening occurred due to difficult Inclusion/Exclusion criteria. • Site Activation: study sites were slow to gain approval and activate for the study. Only up to 48% of study sites originally forecasted were active during recruitment.

• Medici’s highly targeted digital marketing campaign significantly increased number of potential subjects to study sites. • More patients were required to visit the study website and take the pre-screener to offset the high pre-screen fail rate. Medici’s site performance team engaged study sites to achieve a 70% performance rate insuring each patient referred received follow-up.

• The project ended early due to drug safety issues. However, up to study conclusion MediciGlobal was 5% ahead of timelines. • Over 29,563 “clicks” on advertisements, and over 5,405 subjects initiating engagement with the study pre-screener.

The use of online marketing methods to reach the study population was very effective, exceeding the forecasted numbers.


MediciGlobal 2013

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RECRUITMENT PRINT SITE KIT: • Poster / Flyer • Study Visit Invitation • Appointment Reminder Card • Study website

WEB


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MediciGlobal 2013

RECRUITMENT GLOBAL SITE KIT: • Study Brochure • Wall Poster with Tear Pad • Appointment Reminder • Alert Card • Informed Consent Flip Chart • Study Reference Cards • Study Protocol

RETENTION GLOBAL SITE KIT: • Retention Booklets • Thank You Card • Happy Birthday Card • Wall Calendar • Bookmark • Milestone Awards

PRINT


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ALZHEIMER’S DISEASE

CASE STUDIES: 2012/13 project scope:

Provide Global Recruitment and Retention programs for over 141 sites in 10 countries, and support in additional countries via global website.

challenge

solution

result

• Site Activation & Low Site Performance Rates: MediciGlobal lost 21% of its recruitment weeks due to delay in site activations. In addition to the delay in site activations, site performance rates of 54% were well below the forecast of 75%.

• MediciGlobal focused recruitment investment on performing ‘supersites’. • Rapid study awareness included a global scientific webinar, the support of a global Alzheimer’s Facebook page, and ongoing active communications with study sites.

• Despite the delays in site activations and lower than forecasted site performance rate, MediciGlobal has been able to track to a recruitment rate commensurate with its original projections contributing over 50% in total of randomized patients to the entire study.

TIME - WEEKS SAVED 24

40

7

17 WEEKS SAVED

109/7 = 15.6 Study sites without MG randomize approximately 7 subjects per week. Medici randomized 109 subjects in total.

WEB

17 WEEKS TRANSLATES INTO SAVINGS OF 21 MILLION DOLLARS


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CASE STUDIES: 2012/13

CHRONIC IDIOPATHIC CONSTIPATION

project scope: Central online recruitment campaign in US and Canada to deliver quality patient referrals for two chronic idiopathic constipation studies over 26 weeks, with the addition of a customized site kit to support all countries.

challenge

solution

result

• A high rate of referrals were disqualified at the site. A tighter pre-screener was recommended. • Rapid recruitment in a study with delayed site activations, less than engaged study sites and a competitive market place.

• Collaboration between MediciGlobal and PRA focused on site performance, targeted advertising to performing study sites and reinforcing the message that sites were receiving high quality referrals.

• With momentum and marketing increasing, large number of quality referrals are now being sent to sites, with a positive trend in screening and randomization numbers.

Up to 184 Study Sites in 14 Countries

As site confidence increased, so did site performance, with pull-through of referrals increasing as weeks went on.


MediciGlobal 2013

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RECRUITMENT

GLOBAL SITE KIT: • Wall Posters / Flyers • Study Brochure • Study Protocol • Study Reference Booklet • Study Check List • Informed Consent Flip Chart • Study Website

PRINT

WEB


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MediciGlobal 2013

RECRUITMENT SITE KIT: • Wall Poster / Flyer • Study Brochure • Rapid Access Card • Magnetic Reminder • Microsite

PRINT

WEB


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SICKLE CELL

CASE STUDIES: 2013

project scope: US based traditional recruitment campaign targeting pediatric patients with sickle cell disease (SCD) at 40 US centers to deliver quality patient referrals over a 12 month period.

challenge

solution

result

• Pediatric patient population with SCD become eligible to participate in this clinical trial only at the time of hospitalization for acute pain during an acute vasoocclusive crisis (VOC) requiring treatment with a parenteral opioid analgesia. The pediatric population along with their caregivers must be aware of the clinical trial prior to a VOC event occurring so that they are able to contact the clinical staff during the VOC event to determine eligibility.

• Customizing site kit materials to ensure that the pediatric patients and caregivers are provided with all the necessary information regarding the trial and clinical staff contact information in order to enable a connection to occur at the time of hospitalization during an acute vaso-occlusive crisis (VOC).

• By providing the sites with detailed and customized advertising materials, sites are able to share this clinical trial information in a timely manner with all families where a child or children may suffer with sickle cell disease to afford them every opportunity to participate in the clinical trial.


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INTERSTITIAL CYSTITIS

CASE STUDIES: 2013 project scope:

Goal: to take the study out of “rescue” status and deliver patients for a rare therapeutic area. Conducted a national campaign for Interstitial Cystitis/Bladder Pain Syndrome across 43 study centers. challenge

solution

result

• A challenging protocol. A rare condition with low incidence rate. Due to painful symptoms from their condition, travel to study site visits was challenging for women. High pre-screener failure rate due to key protocol inclusion/exclusion criteria. Reinvigorate study sites who were fatigued from recruitment over the past year before Medici’s involvement.

• Provided a unique retention strategy to encourage screening and site visit attendance by patients. • Prescreening of study candidates by web and phone, to reduce the time burden on study sites. • Provide metrics-driven and detailed support to study sites through our Site Performance team. Created healthy competition between sites through a study coordinator recognition program and newsletters.

• Rapidly increased referral rate and site screening visits through Medici’s online marketing campaign. • Our real-time metrics allowed continuous evaluation of site performance and targeting of eMarketing resources. • By tracking trends we were able to adjust strategies on an on-going basis.

TIME - MONTHS SAVED STUDY IS CURRENTLY IN THE MIDDLE OF ITS CYCLE

2.5 12 / 2.5 = 4.8 Study sites without MG randomized approximately 46 subjects in 19 months Medici randomized 12 subjects in total.

PRESCREENING OF STUDY CANDIDATES BY WEB AND PHONE

5

REDUCED THE TIME BURDEN ON STUdY SITES


MediciGlobal 2013

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RECRUITMENT

SITE KIT: • Poster / Flyer • Study Brochure • Study Website

RETENTION SITE KIT: • Gas Card Voucher

PRINT

WEB


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MediciGlobal 2013

RETENTION GLOBAL SITE KIT: • Welcome Brochure • Opt-In Card • Appointment Reminder • Anniversary Card • Birthday Card • Holiday Card • Milestone Catalogue • Milestone Certificates • Magic Calculator • Topical Brochures • Change of Address Card • Annual Wall Calendar

PRINT


PEDIATRIC GROWTH HORMONE

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CASE STUDIES: 2012/13 project scope:

Deliver and maintain a retention programme for a long-term study following patients from childhood to adulthood in 6 countries

challenge

solution

result

• Engaging sites to adopt the retention programme and be engaged in the process. The sites participating do not have English as their first language and have a limited command of the English language .

• A clear and simple retention portal was created for the sites, to enable them to track the participants’ journey through the retention programme, including appointment reminders and contact information maintenance. MediciGlobal arranged 3 webinar training sessions with a live demo, with CRA support. In addition, a simplified user guide was created and used as a training manual for sites that were unable to attend the webinar sessions.

• By providing a user guide that sites can digest at their own pace and convenience, and through email blasts and reminders to maintain contact and keep the portal at the forefront of their minds, MediciGlobal has seen an increase in site update of the portal, measured by logins.


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SKIN LUPUS

CASE STUDIES: 2012/13 project scope:

Recruitment campaign for Systemic Lupus (SCLE/DLE) patients in 20 study sites across the US over a period of 26 – 30 recruitment weeks in 3 separate study cohorts. MediciGlobal’s market research found a low awareness of clinical trials within the community. Therefore, the recruitment program entailed study and clinical trial awareness materials, micro-targeted advertising, site support, and a dedicated call center staff to match and retain qualified referrals. challenge

STRATEGY

• Get the study out of rescue. Bridge the communication gap between patients and sites. Enroll pre-qualified referrals with the contact details of their assigned study site. Encourage study sites to contact and schedule screening visits with their matched referrals.

• Focus on push-pull strategies to establish and maintain referral/site relationship. Medici’s site relations team contacted each study site via e-mail or phone about 4 times for Cohort 1 & 2, and 11 times for Cohort 3. Increased callcenter attention to referrals via phone and mass mailings to ensure that contact has been made with the study site.


MediciGlobal 2013

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RECRUITMENT

SITE KIT: • Patient Brochure • Website • Online Marketing

PRINT

WEB


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ONLINE CAMPAIGNS

RHEUMATOID ARTHRITIS CASE STUDIES: 2012/13 RHEUMATOID ARTHRITIS STUDY for WOMEN project scope: Develop an exclusively online campaign in Canada for recruiting women suffering from Rheumatoid arthritis. Clinical research study in rescue. A high rate of drop out during prescreening occurred due to difficult Inclusion/ Exclusion criteria. Create an exclusively online campaign using targeted, cost effective strategies including online study website, pre-screener and strategic online advertisements. RESULTS: • Significant interest was generated with over 70,000 “clicks” on advertisements • Over 9,900 subjects initiating engagement with the study pre-screener. Received an extension that doubled length of original contract.

PRINT


MediciGlobal 2013

VON WILLEBRAND CASE STUDIES: 2012/13 project scope: Recruitment through online interactive strategies in 10 medical centers in US and Canada

CHALLENGE:

• As Von Willebrand is a rare disease that is under-diagnosed, identifying the right patients was a challenge.

SOLUTION:

• Raising awareness through the specially designed website and social networking page assisted in identifying suitable and interested candidates for the study. MediciGlobal partnered with 3 study sites to develop their own online presence, thus increasing the sites visibility and that of the study.

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GOUT

CASE STUDIES: 2012/13

MediciGlobal brought in the LASSO study for Ardea 5 weeks ahead of time even though the client switched CRO mid stream. The recruitment for subsequent 4 studies produced patient referrals and randomized patients at such an efficient rate that metrics showed it took another recruitment company 6 months to achieve what MediciGlobal delivered in 2 months.

Pre-screened online (Total Contacts)

98,605

Pre-screen to referral ratio

7.4:1

Pre-qualified for an Ardea Phase 3 gout study

1281

Pre-qualified but no study site is nearby

666

Pre-qualified for 301/302 study and referred to study site

775

Pre-qualified for 301/302 study but no site is available nearby

151

Pre-qualified for 303 study and referred to study site

60

Pre-qualified for 303 study but no site is available nearby

71

Pre-qualified for 304 study and referred to study site

828

Pre-qualified for 304 study but no site is available

491

Pre-screened by phone (Total Contacts)

298

Fans to Gout Study Facebook page

70,189

Study sites with Facebook pages that have partnered with Medici on Gout

40

Study sites to be supported by local advertising

98

Site local media campaigns with metrics pending

79

Site local media campaigns with metrics collected

19

Site campaigns launching by end of this month

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Postings made on Gout Study Facebook page Feb28 – Jun7

46

Pre-qualified for 304 study but no site is available

120


MediciGlobal 2013

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RECRUITMENT GLOBAL SITE KIT • Patient Brochure • Wall Poster / Flyer • Informed Consent Flip Chart • Study Invitation • Appointment Reminder • Newspaper Ads • Study Website

Banner ads designed

59

Print ads designed

5

TV ads produced

4

Radio ads in production

4

Retention booklets pages written

48

Recruitment & retention patient/ site-facing documents prepared

15

PRINT

WEB


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MediciGlobal 2013

MEET THE EXPERTS

Our campaign for Gout Awareness effectively drove more than 20,000 readers to the customized site. Positioned on the most trusted news sites around the country, the News Feed’s headlines and images become part of the web reader’s natural editorial selection process, catching their interest and encouraging them to click-through to the custom site. Our technology allows our web editors to change content in real time to attract different interests–that’s why our News Feed has a higherclick through rate than any display advertising.

Custom site Our in-house team interviewed more than 13 leading medical professionals to create the content, including experts from the Gout & Uric Acid Society, Arthritis Foundation and Mayo Clinic, and included exit links to the client’s website and Facebook page. News Feed To bring readers to the Platform, we ran headlines on our News Feed placed in rotation on USAToday. com’s News section. To maximize traffic, our web editors changed headlines in real-time, and despite the niche subject matter, managed to cover a wide range of topics—from diet and fitness to medical developments The Results We drove more than 20,000 visitors to the custom site. Readers spent more than 2 minutes with the content and more than 8% of visitors clicked on exit links, proving once again the power of effective content marketing.


MediciGlobal 2013

Dr. N. Lawrence Edwards, professor of medicine at the University of Florida and chairman and CEO of Gout & Uric Acid Society

Dr. Patience White, vice president for public health at the Arthritis Foundation and professor of medicine and pediatrics at George Washington University School of Medicine and Health Sciences

Dr. Alan Friedman, board of directors, American College of Rheumatology, Research and Education Foundation

Dr. John Pappas, medical director and principal investigator at Kentucky Medical Research Center in Lexington, Kentucky

Dr. Gregory M. Gottschlich, CEO of New Horizons Clinical Research

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Dr. Yuqing Zhang, Professor of Medicine & Public Health at Boston University’s School of Medicine

Dr. William P. Jennings, medical director at Radiant Research, San Antonio

Dr. Clement Michet, consultant in rheumatology in the Mayo Clinic in Minnesota

Dr. Jeffrey J. Cain, president-elect of the American Academy of Family Physicians

Partnership with

www.USAToday.com


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advocacy 2012 - 2013


MediciGlobal 2013

Within the past months, the role of patient advocacy has increased on a global scale. Through our work with advocacy groups we have created patient recruitment models based on equitable exchanges that meet the needs of the patient organizations. At MediciGlobal patient advocacy has been an integral part of recruitment programs for many years, and the company’s inroads into advocacy organizations further enhance the PARS – Medici recruitment team. Interest in advocacy has increased in parallel with the rise in social media. Developing a level of patient engagement offers us the opportunity to capitalize on the value that patient communities possess in providing patient support, fostering patient dialogue, and sharing information about clinical trial opportunities. ALZHEIMER’S DISEASE INTERNATIONAL

LUPUS FOUNDATION OF AMERICA

INTERSTITIAL CYSTITIS NETWORK

NATIONAL FOUNDATION FOR CELIAC AWARENESS

NATIONAL HEMOPHILIA FOUNDATION

EPILEPSY FOUNDATION OF AMERICA

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MediciGlobal 2013

We bring hyper-targeted patient recruitment Over the past 18 months our recruitment programs have undergone a metamorphosis. Today eMarketing and social media strategies account for ~80% of our recruitment outreach initiatives. As a result, our in-house marketing, project management and IT teams have increased in strength, size and dominance.

50 STATES * 50 CONCERTS CANDLELIGHT CONCERT SERIES In 2013, MediciGlobal was proud to sponsor the 50 Concerts in 50 States for Epilepsy Awareness concert series; helping to bring a unified voice to epilepsy awareness across the United States. The series was born out of the tragic passing of Candlelight Concert founder Eric Miller’s wife, Carolina, as a result of an epileptic seizure which she suffered in 2011. From the humble beginnings of small shows hosted in Eric’s New Jersey home, the concert series grew to feature more than 100 performers in all 50 states. During the course of several weekends in March, the series worked in collaboration with several major epilepsy awareness groups to raise awareness and collect donations for epilepsy research. Eric Clapton, Imagine Dragons, Macklemore & Ryan Lewis, Garbage and Colbie Caillat were just a few of the performers to participate, turning their shows into opportunities to inform people about epilepsy. MediciGlobal is excited to support Eric and the Candlelight Concerts for Epilepsy Awareness once again in 2014, as they hope to bring the word on epilepsy to an even larger audience.

With digital strategies continuously changing, it is critical that we have our key team members connected with developers of the key search engines and social networking sites. Our direct relationships and advisory roles mean that we stay abreast of digital change. It drives our continuous innovation! Medici Global knows our recruitment strategies must continuously connect and innovate in the ever evolving world of social media and eMarketing. Additionally, through our collaborations with our client’s regulatory, legal and compliance teams we are implementing social media and eMarketing campaigns within existing regulatory and IRB guidelines.


MediciGlobal 2013

SUPERSITE SUPPORT

LOCAL NEWSPAPER

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access 2 patients


MediciGlobal 2013

SOCIAL MEDIA AND E-MARKETING

“Innovative companies are leveraging the online social networks of physicians, patients and scientists to explore unprecedented opportunity to collect information and collaborate externally.” Terry Hisey, life sciences sector leader at Deloitte

Access to Patients (A2P) is a global marketing company in charge of providing clinical trial recruitment support through collaborative marketing efforts. With experience in recruiting for global clinical trials in areas ranging from Alzheimer’s disease to epilepsy, A2P combines awareness and community building with digital, traditional and social media marketing strategies to guarantee recruitment results.

“At MediciGlobal social media and e-Marketing are at the core of our recruitment feasibility, planning, marketing and advocacy activities” Nick Halkitis, Vice President Global eMarketing and Digital Strategies

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MediciGlobal 2013

EMAIL MARKETING

110 EMAILS

12%

CLICKTHROUGH RATE

36%

OPEN RATE

5.7%

CLICK TO OPEN RATE

4.9%

INDUSTRY STANDARD

35.5%

81

INDUSTRY STANDARD

Emails included a call to action button. These emails performed 16% better than those without AND 16% better than the industry standard.

UNIQUE EMAIL OPEN RATE

UNIQUE EMAIL CLICKTHROUGH RATE

36% 35%

21% 5%

People who receive the email are both opening and clicking through

4% INDUSTRY STANDARD


MediciGlobal 2013

WordPress

Yahoo Health

BlogSpot

Yelp

Google Local LinkedIn

Blogging

Social Networking

Podcasting Media Casting

Vimeo YouTube Instagram

Facebook

Peer Reviews

Tumbler

Google Picasa

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Flickr

Social Bookmarking

Peer Knowledge

Pinterest

Digg StumbleUpon

Twitter

Wikipedia

Yahoo Answers

Our social media campaigns are integrated with eMarketing. Our programs include the following: Pay per click (PPC) advertising: Our eMarketing experts get our studies found on search engines. They drive patients to the study website, and with careful PPC Management they take the guess work out of internet marketing and let study sites and the study teams focus on conducting the study. Our efforts and priorities are devoted to your success through online marketing, reaching the target-patient, and ‘pushing’ patients to get involved with the study and take the online study pre-screener Search Engine Optimization (SEO) Our eMarketing team called Access to Patients™, specializes in online advertising and getting our study website found online even when competition is fierce! By combining SEO (Search Engine Optimization) and PPC (Pay Per Click) strategies MediciGlobal’s eMarketing division is leading the industry in creating highly targeted and effective online advertising campaigns. How does Access to Patients™ know this? ... This year alone we have taken on 2 clinical trials from other recruitment companies. The results achieved were significant! We saved clients time and costs. Social Media Marketing We are leading the way in Social Media Marketing for patient recruitment. Our team gets our studies in front of specific study target-audiences on the fastest growing social network, Facebook, and on other social networking sites (SNSs), such as Twitter and Pinterest, that reach different ethnic populations.


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patient communities


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Developing a level of patient Launched a pro-bono marketing campaign for The Epilepsy Foundation of Florida resulting in winning a grant from the Chase Charity to send 300 kids with epilepsy to summer camp.

engagement that offers us the opportunity to capitalize on the value that patient communities possess in providing patient support, fostering patient dialogue, and

Built the largest epilepsy community on Facebook worldwide.

sharing information about clinical trial opportunities.

Team Epilepsy (260,000+ fans)

Alzheimer’s Team (105,000+ fans)

Gout (70,000+ fans)

Celiac Team (14,000+ fans)

Endometriosis Team (9,500+ fans)

Chronic Constipation (4,200+ fans)

Liver Cancer Team (2,000+ fans)

Sickle Cell Team (1,800+ fans)

Von Willebrand (1,600+ fans)

Completed a survey of cancer patients; their views and perceptions on participating in clinical trials for therapeutic vaccines, stem cell and gene therapy.

Lupus Team (20,000+fans)

Built a unique patient community for Gout which is now the largest on Facebook.

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lost to follow up


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A A P HI NT A I L P COM

RECOVERING MISSING PATIENTS A NEW APPROACH TO LOST TO FOLLOW UP Regulatory bodies around the world are requiring pre-market submissions to be inclusive of all patient data. All subject data must be accounted for and companies must demonstrate diligence in recovering missing data. Additionally, pre-market reviews take longer when clinical trial data issues arise resulting in extensive back and forth with FDA (and other regulatory agencies) during the review process. As a result, the recovery of patients and the accountability of missing data is becoming an emerging issue. In 2011, MediciGlobal launched a first-of its kind online portal for the recovery of missing patientsdeemed ‘lost-to-follow up’ (LTFU).

L2FU is an affiliate of MediciGroup, Inc, and for over three years, this team has quietly been finding patients in the US and Canada. Starting with a major health care system in the US, (Kaiser Permanente) and expanding globally in 2010. In 2011, after 3-years in planning and development, a unique L2FU internet-based portal was launched. Importantly, this portal centralizes all the key aspects of lost to follow up: the transfer of patient data, the upload of critical documentation, death records, photographs, medical release forms, and other documents. The portal is secure and information access is determined by the role each person plays in the lost to follow up process; physician investigators, study coordinators, CRO / ARO team members, patients, study sponsors and our L2FU team that includes internet investigators and field investigators in more than forty countries.

www.L2FU.com


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GOING GLOCAL Global Planning Local Implementation


MediciGlobal 2013

apt® ADapt is a unique web based system that fuses together editorial, design and translation into one single process. Designed specifically with the goal of optimizing patient recruitment and retention, and personalizing patient facing materials regardless of the scale of the clinical study; from thousands of patients to only a few, from many countries to just one or two. Here’s how ADapt is streamlining the patient recruitment-retention planning and development process…

Metric

Traditional Approach of Materials Design for Patient Recruitment and Retention

Automated Approach: ADapt

Labor

Labor intensive: significant design time is required to manually lay out each translated/customized piece.

Design costs are reduced by at least 30%.

Speed

Slow process: Word files go through translation, back into design, and then back to countries for final review.

Up to 4 weeks shorter by country/customization, since content, translation and design are ‘fused’ together in one system.

Ethics generally reviews Word documents,

Ethics reviews designed materials. Changes are made in the system – and fast. Files are print-ready once approved by ethics, so there is no need for another design step.

Faster Recruitment Launch

review, which can add several weeks to the process.

Efficiency

Multiple people, layers and steps make the process inefficient.

There are fewer people and layers, as translation, design and cultural adaptation are all housed in one place.

Project Management

Significant project management requirements to coordinate translators, designers, timelines, etc.

Minimal project management time needed.

Tracking of Materials Development

Manually tracking of the development and review of recruitment materials for each country.

Real time-paperless tracking of the development and review of recruitment materials for each country.

Accountability

No formal “agreement of accuracy”: Final sign-off is obtained on a systematic basis.

Formal agreement of accuracy: all copy, design and translation are signed off by designated country representative, to ensure acceptance of accountability and ownership.

Control

Version control can be hard to maintain with a manual process.

Version control is ensured, as reviewers make edits to a single, centrally housed document.

Quality

Comparable.

Comparable.

Scalable

Scalability is limited, dependent on labor and resources.

Limitless scalability – can incorporate large number of countries and individual sites at low cost.

Glocal: Global Planning – Local Implementation

Time and cost constraints to involve input from local country level do not make this process feasible.

Local input is encouraged. Ability to adapt down to the individual site level if desired, not just in terms of text, but also graphics.

Flexibility

Restricted to hours of operation in a given country.

No time zone restrictions – accessible globally, 24/7.

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Š Copyright 2013, MediciGroup, Inc. d/b/a MediciGlobal

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