PREP Course #17: Are we there yet? Achieving Enrollment Success

Transcription

1 PREP Course #17: Are we there yet? Achieving Enrollment Success Cerdi Beltre, CIP, CCRP Administrative Director, Clinical Research Service Director, Clinical Research Operations, NSLIJ , Presented by: Amanda Galvin Recruitment Coordinator Clinical Research Service ,

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planners: Kevin Tracey, MD, Cynthia Hahn, Emmelyn Kim, MPH, and Tina Chuck, MPH have nothing to disclose. Course Speakers: Cerdi Beltre and Amanda Galvin have nothing to disclose

3 Objectives and Content Review recruitment plans and resources available to conduct human subject research Discuss current state of recruitment across the health system Discuss why investigators/sites over-project on enrollment targets Review resources available to help meet enrollment goals

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5 SOP on Recruitment and Retention Subject Retention: The relationships that the research team builds with the subjects may be the most important factor in continued participation; therefore, the following will be incorporated as feasible and appropriate: take notes on subject s interests and ask about it at follow-up visits, provide helpful information about the disease and resources at the health system, provide an appreciation package, gather the team for a proper goodbye, use of debit cards for visit compensation, Make-it-Right Cards for service recovery, and provide certificate of participation when their participation is over.

6 Recruitment Plan Worksheet

7 Best Site Practices Site Performance: Study Start-Up, Recruitment & Retention SOPs Enrollment Retention IRB Approval Budget/ Contract -Document compliance -Written study recruitment and retention process/plan Meets at least 70% of enrollment goal on each study At least 70% of patient retention -Within 30 days from independent (commercial) IRB -Within 60 days from local IRB Responds within 14 days of receiving documents Society for Research Sites: Responsible Site Management, Best Site Practices. SCRS White Paper. October 2014

8 Facts and Figures 70% of research sites under-perform in the US 50% enroll zero to one patient 39% meet enrollment targets worldwide 13% exceed enrollment targets worldwide New Research from Tufts Center for the Study of Drug Development Characterizes Effectiveness and Variability of Patient Recruitment and Retention Practices, Press Release, Jan. 15, 2013 Pierre C. Recruitment and Retention in clinical trials: What works, what doesn t and why. Presented at: 2006 Drug Information Association Annual Summit; June 2006; Philadelphia, PA

9 Facts and Figures Don t Panic! NSLIJ Comparison 70% of research sites under-perform in the US 82% NSLIJ BRANY Q3 Closed Studies (overall average percentage of enrollment): 47% 50% enroll zero to one patients 40% 39% meet enrollment targets 13 out of 73 studies enrolled 70% or better 13% exceed enrollment targets 10% NSLIJ figures based on BRANY Sept enrollment report, excludes non-brany managed studies.

10 Zero Enrollment at NSLIJ (Q3 2014) Closed by sponsor Site declined to continue with the study Enrollment completed by other sites (3) Sponsor delays/late add-on site Zero Enrollment Need central service support -Assistance from Marketing, CRS -Limits on distinguishing individual site from NSLIJ/Feinstein Extension study - subjects didn't want to continue Inadequate process/plan at site Delay in Hospitalists referrals Difficult enrollment criteria (6) A snapshot

11 Why do we overestimate enrollment targets? Site: Enthusiastic and optimistic investigator Unrealistic not based on actual data (pts or time) We re doing great! Or Better than what we expected! If we didn t give those numbers, we wouldn t have been chosen Sponsor: Fear sites can t handle the truth (demoralize or ruin the relationship?) Keep performance metrics including on enrollment what does your contract say? Perception Internal and External

12 Why does zero or low enrollment matter? Uncompensated impact of lowenrolling studies: $1 million per year Exposure to risk without the scientific or longterm clinical benefit Diminished ability to achieve study objectives, scientific/clinical benefit Collaborations? Investments? Sponsorships? Cost Unethical Medical Advances Future Research Shared goal: improving health and lives Acad Med. Nov 2011; 86(11): The Prevalence and Economic Impact of Low- Enrolling Clinical Studies at an Academic Medical Center. Acad Med. Nov 2011; 86(11): Commentary: Improving Participant Recruitment in Clinical and Translational Research

13 Pause and Evaluate Feasibility/ Selection Start-up/IRB Study Conduct Address Slow Enrollment Post Study Analysis EMR data on volume Investigator and nonresearcher physician interest/ commitment Resources Evaluate study complexity, competing studies, facilities, $ Recruitment plan passive and active recruitment methods Plan A and B Track enrollment progress What is working? What s not? Issues with: -Protocol, -Site, -Investigator /physician engagement -Patient Outcome How you reached that outcome Lessons learned Changes? Strengths 1. Can J Surg. Jun 2010; 53(3): How to optimize patient recruitment

14 Performance Metrics Who is tracking performance? Sponsors/CROs from study start-up to CRF queries per patient Metrics Champion Consortium 10 objective measures from the sponsor/cro perspective Transcelerate investigator registry and shared portal Research Resonance Network benchmark performance metrics from the site s perspective Others including us

15 Performance Metrics Report Card 1. How valuable would it be for you to receive a post-study site report card for your site from the Sponsor showing your site s performance metrics against the study norms on such items as query rate, turn around time, screen failure, etc.? -Majority of respondents noted it would be Extremely valuable 2. If you received a post-study site report card would it change how you conduct your work? -Majority of respondents indicated Definitely Society for Research Sites: The Quest for Site Quality and Sustainability, Perceptions, Principles and Best Practices. SCRS White Paper. October 2014

16 Thank you!

17 Recruitment Resources and Strategies Amanda Galvin Recruitment Coordinator Clinical Research Service

18 Resources EMR Physician Communication Public Relations Recruitment Registry HealthPort E-News Bulletin Feinstein Website Community Relations

19 Use of Electronic Medical Records Leverage the health system EMR database to find out where patients with your study s specific eligibility criteria are located. Real time patient identification for recruitment Reports sent at frequency of your choice (weekly, daily, etc) Use reports to: Find inpatients in hospital Find outpatients by reviewing appointment data (and approach patients during their visit if physician approves) Contact the patient s physician to inform them of your study and ask if they would refer eligible patients Contact Annette Lee, Ph.D, Assoc. Investigator

20 Use of Electronic Medical Records Example project: Sepsis study Identify early signs of sepsis in inpatients at NSLIJ Time sensitive subject enrollment (patients enrolled within a specific time frame) Using selection criteria, generated reports (per hospital) of potential participants

21 Physician Communication Physician Lists Based on therapeutic area and geographic location Physician Liaison Team (all physicians team has visited) Credentialing Office (all NSLIJ physicians) Advertisement Distribution Physician liaison team will provide physicians with research advertisements during their normal office visits

22 Public Relations Helps to promote and publicize studies in a variety of ways Local media Internal communications across the health system Newsletters that are distributed throughout NY Contact Emily Ng, Research Communications Manager

23 Free and secure registry The Recruitment Registry Participants of any age, race, ethnicity or health status can join NSLIJ investigators with an IRB approved protocol may request lists of participants based on eligibility criteria and may contact them to see if they would like to participate in their studies Over 800 participants currently enrolled and an online portal for registration has been created Contact Amanda Galvin, Recruitment Coordinator

24 Recruitment Registry Case Study Background Cognitive cancer study in which healthy volunteers needed to enroll within 60 days of each patient. Healthy volunteers had to be the same gender and within five years of age of the patient. Recruitment Method: Feinstein Recruitment Registry 9 out of the 16 healthy volunteers were from the Recruitment Registry It has saved me so much time. I don t know what I would do without it

25 NSLIJ intranet system HealthPort Advertise on the Events page advertisements can be set to repeat throughout the year Research Coordinators Feedback I found the healthport events page extremely helpful when recruiting healthy volunteers By far our most successful method for recruitment

26 E-News Bulletin Weekly to all NSLIJ employees (over 50,000) Advertise your research study -Employees may have patients or know someone who is eligible for your study Follow Content Guidelines and submissions to by Tuesday at Noon -Make sure to include in your that language provided can not be edited

27 Feinstein Institute Website Posting Advertise research studies to the community who may be looking for studies to participate in Show fellow colleagues the research that is currently being conducted Application can be found on the Feinstein Institute website Resources for Investigators» Clinical Research Services» Application & Request Forms» Post a study on Feinstein website form Contact Amanda Galvin, Recruitment Coordinator

28 Feinstein Institute Website Posting

29 Community Relations Helps increase awareness of clinical research by engaging and collaborating with our communities. The NSLIJHS Community Advisory Board for Research Studies (CAB) can provide advice about social, ethical and communal matters to investigators conducting research, pre or post IRB approval. Researchers that are interested in making presentations to various communities about their work or at the CAB meeting are welcome to contact this department. Contact Gila Klein, Community Relations Manager

30 Other Resources Marketing Digital Strategy Call Center (receives ~52,000 calls every month) The Recruitment Core is currently engaged in a project where we plan to pilot various recruitment strategies from these departments

31 Additional Strategies Internal Communication Community Outreach Support Groups Disease Specific Organizations

32 Internal Communication Build strong relationships with clinical teams including nurses to promote clarity, understanding and support of the study PI s to meet, speak and/or present study to clinical teams and include a discussion of the importance of research and how it will impact the future Meet and educate clinical teams on a regular basis and review inclusion and exclusion criteria with them to keep them informed, and also to keep the study relevant

33 Support groups Community Outreach Access to target population to promote study Members may be seeking new treatment options Collaborate and build strong relationships with advocacy groups, foundations and other organizations Advertise study in newsletters, s, social media, and other material that organizations send to their members Participate in events, talks and other educational initiatives Attend disease-specific meetings to increase physician referrals Active community presence Have research team available to community to answer questions and give advice which helps build trust

34 Questions? Comments? Concerns?