BEST PRACTICES IN PREVIEW OF BEST PRACTICES IN PATIENT RECRUITMENT

Transcription

1 BEST PRACTICES IN PREVIEW OF BEST PRACTICES IN PATIENT RECRUITMENT AUGUST, 2016

2 REPORT OVERVIEW Patient recruitment is a primary concern of the clinical trial industry. Every day that a clinical trial goes beyond its intended deadline the sponsor organization could lose hundreds of thousands to millions of dollars in sales.,, and sites engage various means to reach key milestones on time and within budget. To provide the best perspective on this critical topic, ISR gathered opinions from key decision-makers at three different types of stakeholder organizations: sponsors,, and sites. Further, we explored the increasingly important role of specialized patient recruitment firms by examining their market penetration, value, and performance. 210 PAGES 304 CHARTS AND GRAPHS DATA COLLECTION IN Q1, MINUTE WEB-BASED SURVEY 103 RESPONDENTS FROM SPONSORS, CROS AND SITES VALUABLE FOR CLINICAL OPERATIONS EXECUTIVE MANAGEMENT INVESTIGATORS & SITE MANAGERS THERAPEUTIC AREA HEADS SITE RESEARCH COORDINATORS SITE PRINCIPAL INVESTIGATORS CLINICAL DEVELOPMENT PATIENT RECRUITMENT WHAT YOU WILL LEARN Which entity (sponsor, CRO or site) has the greatest potential to impact patient recruitment success and why Key drivers to successful patient recruitment, including which study characteristics impact participation Respondents insight into their approach to recruiting for a global trial, including country selection factors and challenges for which to be prepared How you can use this report Know when and how to engage a specialized patient recruitment firm to get the best value Understand the value of various patient recruitment tactics and the best sources for recruiting patients Employ best practices identified by industry peers to improve the likelihood your clinical trial will be completed on-time and within budget FOR PHARMA Shortlist strong performing and Specialized Patient Recruitment Firms for future patient recruitment needs FOR SERVICE PROVIDERS Benchmark your company against the competition in terms of meeting client expectations, satisfaction, and quality MAJOR SECTIONS: 1. Facilitators & Barriers to Patient Recruitment Success 2. Specialized Patient Recruitment Firms Market Overview 3. CRO Performance Ratings on Patient Recruitment 4. Study Data Full Table of Contents on next page.

3 TABLE OF CONTENTS COPYRIGHT AND USAGE GUIDE INTRODUCTION METHODOLOGY PARTICIPANT CRITERIA FACILITATORS & BARRIERS TO PATIENT RECRUITMENT SUCCESS Primary Findings Which entity has the greatest impact on recruitment success? Recruitment success drivers unprompted Recruitment success drivers prompted Value of recruitment tactics Current and future patient recruitment tactics Recruiting patients for global programs Patient recruitment challenges in global clinical trials unprompted Global trial country selection factors SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW Primary Findings Source of patients recruited Specialized patient recruitment firm usage Utilization strategies Importance of specialized patient recruitment firm services Specialized patient recruitment firms provide more value than adding sites Specialized patient recruitment firm use by company Specialized patient recruitment firm performance ratings Specialized patient recruitment firm scorecards Budget Capabilities Timing Scorecard performance summary Quality index performance ratings CRO PERFORMANCE RATINGS ON PATIENT RECRUITMENT Primary Findings CRO patient recruitment scorecards Budget sponsors Capabilities sponsors Timing sponsors Capabilities sites Timing sites Quality index performance ratings STUDY DATA Entity with the most power to impact recruitment success Recruitment success drivers unprompted Recruitment success drivers prompted Recency of using patient recruitment services Patient recruitment services meeting expectations Recruitment vendor structure for global programs Challenges faced in recruiting patients into global clinical trials unprompted Global trial country selection factors Value of recruitment tactics Current and future patient recruiting tactics Source of patients recruited Specialized patient recruiting firm use Specialized patient recruitment firm performance Value of specialized patient recruitment firms recruiting efforts Strategies for specialized patient recruitment firm use Importance of specialized patient recruitment services Most important aspects of specialized patient recruitment firm services Specialized patient recruitment firms offer more value than additional sites CRO PATIENT RECRUITMENT DRILL-DOWNS Accell Accelovance Accenture BioClinica Bioskin Celerion Chiltern (including Theorem) Clinical Research Services (CRS) Clinipace Clinlogix

4 TABLE OF CONTENTS Clinsys Cognizant Covance DaVita Clinical Research DCRI-Duke Encorium Eurofins Eurotrials Frontage HungaroTrial ICON Inamed INC Research inventiv Health Clinical KCR Lambda Medpace Medsource NAMSA Novotech PAREXEL Pharm-Olam International PPD PRA Premier Research ProTrials QPS Quintiles Rho SanaClis SGS Life Sciences Southern Star SPRI Clinical Trials Symbio SynteractHCR Tata TKL Research West Coast Clinical Trials Worldwide Clinical Trials SPECIALIZED PATIENT RECRUITMENT FIRM DRILL-DOWNS Academic Network (a Stericycle company) Acurian (a PPD company) BBK Worldwide CAHG Trials Clariness Clinical List America Clinical Site Services Clinical Trial Media DAC Patient Recruitment Services MediciGlobal MMG PatientsLikeMe Patient Recruiters International Praxis Communications Resolutions Rapid Enrollment Solutions Synexus The Patient Recruiting Agency Threewire RESPONDENT PROFILE Organization type Responsibilities Interaction with functions ABOUT INDUSTRY STANDARD RESEARCH 304 CHARTS AND GRAPHS SAMPLE PAGES

5 SAMPLE PAGE: RECRUITING PATIENTS FOR GLOBAL PROGRAMS This page shows how sponsors and differ in their approaches to patient recruitment for global programs. The full data is available in the report, which can be downloaded from FACILITATORS & BARRIERS TO PATIENT RECRUITMENT SUCCESS Recruiting patients for global programs and differ in their approaches to recruiting patients for global programs. are more likely to engage one recruitment vendor for the entire program than (64% vs 47%). More than half of the respondents from report they engage multiple firms in some form to recruit for global programs. For a global program, do you most often? (n=58) (n=19) Use one recruitment vendor for the entire program Industry Standard Research 47% 64% Select one company for the home country and another for all other countries 11% 22% Select one company for each country or region included in the study 10% 26% Mix methods/case by case decision 3% 16% 0% 20% 40% 60% 80% % of Respondents DATA IN FULL REPORT Best Practices in Patient Recruitment 18

6 SAMPLE PAGE: UTILIZATION STRATEGIES Among, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm. SPECIALIZED PATIENT RECRUITMENT FIRMS MARKET OVERVIEW Utilization strategies use specialized recruitment firms for a variety of reasons, with no single strategy standing out as a primary motivation for engaging a specialized recruitment firm. Among, use of specialized recruitment firms to accelerate timelines (27%) stands out as the most popular strategy for engaging a specialized recruitment firm. On what percent of your studies do you utilize a specialized recruitment vendor for the following strategies? (n=60) (n=18) Speed from the onset (use additional resources to increase recruitment from the start of the study) 11% 15% Rescue (bring in a vendor mid-trial when you anticipate or are experiencing lower-than-anticipated site enrollment rates and delays) 11% 14% DATA IN FULL REPORT Acceleration (in a highly competitive scenario where you need to shorten enrollment timelines with the same number of sites) 14% 27% Industry Standard Research Risk Mitigation (using your same number of sites, use the recruitment company's "reserve of patients" as a buffer in the event of a site enrollment fall off) 12% 15% Unknown therapeutic area (when a study is in a TA you have little experience in) 6% 12% High efficiency (reduce the number of sites to achieve the same # of patients) 11% 18% 0% 10% 20% 30% % of Studies Best Practices in Patient Recruitment 25 Acceleration (in a highly competitive scenario where you need to shorten enrollment timelines with the same number of sites) Risk Mitigation (using your same number of sites, use the recruitment company's "reserve of patients" as a buffer in the event of a site enrollment fall off) Unknown therapeutic area (when a study is in a TA you have little experience in) High efficiency (reduce the number of sites to achieve the same # of patients) Industry Standard Research 6% 12% 12% 11% 14% 15% 18% 27% 0% 10% 20% 30% % of Studies CLOSER LOOK << were least likely to cite an unkown therapeutic area as the reason to engage with a specialized recruitment vendor. Data available in the full report, which can be found at:

7 SAMPLE PAGE: CRO PATIENT RECRUITMENT SCORECARDS This page shows how 16 were rated by sponsors on their patient recruitment capabilities, enabling readers to quickly identify leaders in the industry. The full data is available in the report, which can be downloaded from CRO PERFORMANCE RATINGS ON PATIENT RECRUITMENT Capabilities sponsors Ability to provide transparency of recruitment performance throughout the process Ability to support patient retention throughout the trial Number of patients who pass the screening criteria Quality of referred patients that pass the screening criteria Company Accenture #1 (n=16) Company BioClinica #2 (n=14) Chiltern (including Company Theorem) #3 (n=13) Clinical Research Services Company (CRS) #4 (n=14) Company Cognizant #5 (n=15) Company Covance #6 (n=28) Company DCRI-Duke #7 (n=11) Company Eurofins #8 (n=10) Company ICON #9 (n=29) Company INC Research #10 (n=14) inventiv Health Company Clinical #11 (n=18) Company PAREXEL #12 (n=33) Company PPD #13 (n=28) Company PRA #14 (n=20) Company Quintiles #15 (n=37) Worldwide Company Clinical Trials #16 (n=15) Ratings Key: Clear leadership Better than most About average Falling a bit short Likely deficiency Best Practices in Patient Recruitment 44

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10 THE ISR DIFFERENCE act with confidence ISR S REPORTS VS. THE COMMON SYNDICATED REPORT ISR S HEALTH PANEL The industry s fastest growing panel of health care and pharmaceutical professionals, with nearly 1,500 members worldwide. Other 6% CRO 6% Research Site 10% RESEARCH METHODS Mostly primary research; always appropriate for the topic BY COMPANY TYPE One size fits all; usually publically available data Sponsor 78% DATA COLLECTION ISR s proprietary data tools and channels support fast, high quality data collection Struggle to recruit the right targets and enough of them C-level 13% Manager 29% BY JOB LEVEL RESPONDENTS Sophisticated screening ensures genuine decision-makers make up respondents VP 10% Undisclosed methodologies and respondent demographics Director 46% SAMPLE SIZE Robust sample sizes that instill confidence Often insufficient industry representation that leaves you defending results 3-5 years 5% 6-10 years 11% 20+ years 37% BY EXPERIENCE IN YEARS ANALYSTS Decades of experience means more insights that are immediately usable Junior analysts capable of reporting numbers years 24% years 23% Preview of: Benchmarking the Pharma Industry s HEOR Functions 10 To learn more, visit