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Clinical trial recruitment overview


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Challenges and opportunities in clinical trial recruitment in an age of personalized medicine.

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Clinical trial recruitment overview

  1. 1. Patient Recruitment Brief overview by InnoAction Advisory Services (
  2. 2. • The clinical trial recruitment market is estimated to be between $1.2-$1.8B • Since 2000, the number of studies being conducted has gone up from ~5K to nearly ~150K, globally, increasing complexity, as well as site & patient recruitment demand • At the same time regulatory requirements have increased the size of trials, requiring on average 3.5-4K patients per trial (and increasing shift towards PMx) • Patient recruitment remains the biggest factor in enrollment and trial delays – now taking an average of ~8 years from the start of a trial to approval • Patient recruitment costs average at ~6% of trial costs, going up to 10%, while doubling the timelines for Phase II-IV trials to meet desired enrollment levels • Further, 11% of sites end up enrolling no patients, while an additional 37% of sites chronically under enroll patients for trials • Little has changed by way of operating model or technology impact to create step- wise change in the patient recruitment model over the decades Confidential – Do not copy or distribute | 1 Executive Summary
  3. 3. • On average, less than 5% of patients in a therapeutic category are aware about clinical trials, and even fewer raise their hand to participate in a trial • Of patients that are identified, 2-3% actually make it past screening, into randomized selection, and trial completion • However, of those that do participate in trials, most have a positive experience, and ~90% would participate in trials again • There is a significant opportunity take a patient-centric approach, combined with technology, data, and analytics to grow the size of the patient recruitment pie • However, this will require a rethink to traditional processes and operating models – Leveraging data and analytics for practical protocol design – Early input from key investigators on protocol design – Use of technology and data to identify patient concentrations by geography – Selecting appropriate sites based on patient availability – Working closely with sites to attract and maintain patients throughout the trials – Patient-centric design e.g. using local infrastructure & mobile/ remote tools Confidential – Do not copy or distribute | 2 Executive Summary
  4. 4. There is significant opportunity to redefine patient recruitment Patient Recruitment Challenges Market Opportunity Very low awareness of trials by patients Digital awareness & education High fear & trust issues by patients Medical education Low patient convenience & access Patient-centric design Low awareness of trials by physicians Targeted physician education Complex (exclusionary) trial protocols Protocol feasibility assessment & investigator feedback Poor use of data & automation Digital, mobile, & big data investments Inefficient trial/ recruitment processes Redesigning some processes Privacy rules and concerns Allowing for dynamic patient consent
  5. 5. Industry will need to enhance its connectivity & engagement assets to drive more efficient & patient-centered trials Portal a. Develop patient consent-based portal b. Allow patients ability to upload personal data c. Create linkage between providers-patients d. Provide effective education & communication e. Allow for patient & provider referrals f. Provide visualization & planning tools for protocol feasibility & patient recruitment g. Enable researchers to conduct privacy/ consent-based searches h. Enable near-patient collection & virtualization of trials (smart phones, devices, data mgmt.) i. Link Lab, AP, Gx & external data sources over time for precision medicine services j. Create deeper engagement (incentives, gamification, social networks …)
  6. 6. Industry will carefully have to navigate privacy rules & regulations as well as physician and patient concerns to establish trust Key Privacy Use Cases Regulatory Feasibility Considerations Link to general clinical trials site on portal  Follow communication SOP Link to specific clinical trial based on patient lab values on portal  Allowed under HIPAA research provision Outreach to health volunteers  Follow communication SOP Outreach to patients who fit trial criteria  Allowed under HIPAA research provision Sharing identifiable patient & trial info with patient’s physician  Only data for physician’s patients Sharing identifiable patient info with third party  Requires patient consent Outreach to patient’s physician within network  No restrictions Sharing physician information with investigators (for trial recruitment)  Follow communication SOP Sharing de-identified patient info with third party  Compliance with de-identification SOP
  7. 7. The monetization model will evolve as the solution matures, leveraging various potential revenue streams Base License Fee Patient ID + Recruitment Fee Value-added Services Fee • Traditional software/ data licensing fees • Annual license based on users/ seats • Per patient fee for identified patients that meet criteria • Per patient fee for patients recruited into trial • Project fees for using “near patient” infrastructure • Potential “freemium” model for patients and providers • Potential advertising revenues on portal(s)
  8. 8. • While clinical trial protocol design and recruitment services are highly inefficient and cost sponsors billions of dollars, change to traditional models has been very slow • Historically, few data and technology driven players have been successful in shifting the clinical trials paradigm – Lack of appropriate and statistically representative data – Inability to create patient and provider scale on their platforms – Long cycle times selling to Pharma & CRO’s – Lack of pharma R&D and healthcare knowledge • One size does not fit all – the solution(s) have to be carefully designed and curated by disease area, and should align with Pharma R&D spend • No one organization can “build” the entire solution – partnerships are a critical success factor e.g. data, technology, advocacy groups, media partners, etc. • Traditional top-down models for solutions development have generally failed – Iterative approaches that use human-centered design & agile development can de-risk – Patient & provider-centricity should sit at the heart of the approach Confidential – Do not copy or distribute | 7 Risks & Challenges
  9. 9. Industry overview & challenges Confidential – Do not copy or distribute | 8
  10. 10. A 2012 Tuft’s estimate put the US patient recruitment market at $1B
  11. 11. 37% of sites under-enroll, while 11% don’t enroll at all
  12. 12. Recruitment is the biggest contributor to enrollment & trial delays
  13. 13. Lack of awareness is a significant issue in patient recruitment Source: Harris Interactive, Centerwatch 16% 84% Unaware or unsure that trials was an option Aware but unwilling Top 5 Reasons Physicians Don’t Refer Patients to Trials n = 6,000 Reasons patients did not participate in trials Of these, 75% would have enrolled had they known it was possible
  14. 14. Patient recruitment can account for up to 10% of a trial’s budget, while comprising a significant amount of economic risk
  15. 15. Reasons why patients don’t participate in clinical trial (based on physician survey) (8*, 0%) (6, 2%) (7, 1%) (1, 44%) (4, 18%) (3, 10%) (2, 17%) (5, 8%) 1. Lack of knowledge on where to look for information on clinical trials 2. Lack of knowledge about what clinical trials actually are (e.g., objectives and processes) 3. Lack of trust in the purpose of clinical trials 4. Fear of clinical trial processes, potential adverse effects, or receiving a placebo 5. Lack of patient referrals from physicians 6. Extensive inclusion / exclusion criteria that prohibit many patients from qualifying 7. Barriers to accessing clinical trials 8. Other*  A total of 169 respondents chose one of the above as the most important reason that so few patients choose clinical trials as a treatment option  The following three accounted for 79% of the total responses  Lack of knowledge on where to look for information on clinical trials (74)  Fear of clinical trial processes, potential adverse effects, or receiving a placebo (31)  Lack of knowledge of what clinical trials actually are (e.g., objectives and processes) (28) * “Other” includes lack of motivation, patient demographics, and insurance issues Total Number of Respondents 169
  16. 16. Appendix (additional industry/ market insights) Confidential – Do not copy or distribute | 15
  17. 17. Over the last 13 years, the number of registered studies has grown by 25x, with increasing complexity of patient recruitment
  18. 18. While US & EU still account for ~70% of global trials, other regions continue to make headway, especially East Asia
  19. 19. High level study management process PI reviews protocol synopsis If PI wishes to proceed, confidentiality agreement signed Full protocol with site questionnaires sent to site Questionnaires returned & reviewed, site visit conducted Final docs submitted – IRB approval, consent forms Contract negotiation and signing Patient enrollment preparations Enrollment initiated Enrollment completed Data analysis & reporting Study lock-up
  20. 20. Site challenges in patient recruitment Develop IIP and CSA Site Selection Recruitment Outreach/ Advertising Patient Follow-Up Recruitment Monitoring • Site selection strategy and patient recruitment strategies not coupled • Site evaluation and selection process not driven by a standardized set of performance metrics • Site assessment evaluation only focused on recruitment #’s and does not include assessment of other factors such as geographic location or local demographics • No clear accountability or decision rights for patient recruitment strategy & effectiveness • Lack of standardized processes for development of patient recruitment strategy • Minimal enforcement and encouragement of study teams to leverage in-house patient recruitment expertise • Lack of metrics and data used to drive outreach/ advertising strategy Key Factors Affecting Recruitment Key Issues in Patient Recruitment Process • Lack of metrics defined to capture effectiveness of recruitment practices • Lack of standardized metrics and process to track patient follow-up for all sites
  21. 21. Site challenges in patient recruitment Unfavorable perception of industry Competition for limited # patients Lack of awareness by patients Lack of awareness & support by physicians Competition for limited # sites Practical barriers facing patients Complex protocols ExplanationIndustry Challenges • 7% of public believes Rx companies care about public good • 14% of Americans believe drug companies “honest” (similar ratings for tobacco, oil and used car sales) Source: Decision Resources, ResearchAmerica!, Harris Interactive; Tufts CSDD • Even in TA’s with more “involved” patient base (e.g., breast cancer in US), inadequate number of patients to fully assess all drugs in pipeline (over 750 breast cancer trials currently recruiting, over 160 in NY alone) • Nearly 85% of patients in a survey stated they were unaware that trials were an option • 31% of physicians surveyed did not refer patients to trials due to lack of information • Also report unwillingness to “lose control” of patient care, concerns of admin burdens, concerns of patient reactions to referrals • From 2001-2005, only 8,600 new investigators compared to over 35,000 new studies • Language barriers, transportation issues, family obligations, financial barriers all cited as reasons why qualified patients do not enroll • From 2002-2006, mean number of inclusion criteria rose from 10 to 26; for exclusion criteria from 21 to 23
  22. 22. Key insights & feedback from sponsors
  23. 23. Top mentions of clinical trial recruitment services companies
  24. 24. Quintiles patient networks rank high with sponsors
  25. 25. Social and mobile trends are highly favorable in the healthcare industry and can drive innovation in clinical research
  26. 26. Myths about social and mobile solutions in healthcare …
  27. 27. Top reasons consumers chose to participate in clinical research
  28. 28. Most people who participate in studies would do so again …
  29. 29. Research volunteers by phase of research
  30. 30. Study participant experiences
  31. 31. Illustrative trial process & timelines 1. Limited marketing expertise and planning insight put sites at risk of failure 2. Challenges in patient recruiting require greater investment in more personalized emerging channels
  32. 32. Illustrative benefits of improving trial process & timelines