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Charles Rathmann, Director, REC ICTS Regulatory Support Center

3 rd Annual Clinical Research Management Workshop " The Recruitment Enhancement Core " Innovative Recruitment Strategies for Washington University School of Medicine. Charles Rathmann, Director, REC ICTS Regulatory Support Center Washington University School of Medicine June 22nd, 2010.

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Charles Rathmann, Director, REC ICTS Regulatory Support Center

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  1. 3rd Annual Clinical Research Management Workshop"The Recruitment Enhancement Core"Innovative Recruitment Strategies for Washington University School of Medicine Charles Rathmann, Director, REC ICTS Regulatory Support Center Washington University School of Medicine June 22nd, 2010

  2. Enrollment Enhancement Project (EEP) • Began in early 2006. • Identify root causes of WUSM enrollment problems and develop potential strategies for improvement. • A streamline & efficient enrollment process to: • Include thousands more participants into leading-edge trials by using a systematic & data-driven approach; • Support the answering of revolutionary research questions • Offset the labor costs involved in getting trials up and running; • Accelerate the clinical research process to bring useful treatments to patients.

  3. Enrollment Enhancement Project (EEP) • In 2005, clinical trials at Washington University were enrolling at 60% goal on average – numerous issues identified for this.*** • The EEP showed: By creating a more efficient enrollment process, this increased subject enrollment will help off-set the tremendous amount of labor & start-up costs incurred by the sites before the trials are up and running and during trial execution. • The Recruitment Enhancement Core (REC) was developed in late 2006 as a direct result of this EEP as well as the need for a Participant Recruitment Core (CTSA)

  4. Enrollment Enhancement Project (EEP) • The REC focus was a systematic, data-driven and strategic approach in the clinical research environment – very metrics driven and customer oriented (corporate mindset in an academic setting). • Strategic Recruitment Plan Development and implementation. • REC Pilot was developed and implemented – 25 trials over 3 therapeutic areas - enrollment was at 125% for studies in the pilot after 12 months.

  5. Participant Enrollment PILOT PROJECT METRICS (Enrollment and Randomization Update – Final Pilot Numbers)

  6. The Recruitment Enhancement Core (REC) The Vision • The REC takes responsibility for enhancing recruitment by passing a steady stream of pre-screened participants to PIs and study coordinators for more predictable and timely enrollment. • The REC also provides assistance with creating targeted, comprehensive strategic plans for participant recruitment, which maximizes recruitment efforts for targeted clinical trials (which includes creative solutions to rejuvenate the execution of difficult-to-enroll trials)

  7. The Recruitment Enhancement Core (REC) The Vision (cont.) The goal of the REC as a centralized resource, is to free up the time of study coordinators and PIs, so they can focus on consenting and enrolling participants, while we spend the time trying to get interested, pre-screened participants to the studies that they desire to be included in.

  8. The Recruitment Enhancement Core (REC) • Recruitment Enhancement • Systematic, Data-driven and Proactive Approach • Strategic Planning and Implementation • Recruitment Services Menu – Levels of Service • Volunteer for Health (VFH) Office and Program • Space in South BJH Lobby • VFH Program is still focused on customer service • Research Participant Registry (RPR) powered by VFH • Database with Potential Participants • Queriable to specific inclusion and exclusion criteria

  9. The Recruitment Enhancement Core (REC) Levels of Service – Support is cumulative • Level 1 • RPR Db query and referrals, Web registration and posting, Flyer creation for office (recommended for all studies). • Level 2 • Media Development and Placement Support (print – free or paid, radio, TV, e-mail blasts, etc.)

  10. The Recruitment Enhancement Core (REC) Levels of Service – Support is cumulative • Level 3 • Strategic Plan Development/Accountability (3 minimum avenues of recruitment per phase) , Staff meeting collaboration/Roundtable support • Level 4 • Strategic Plan Implementation - Level of support , enrollment

  11. Participant Recruitment Strategic Recruitment Planning Meeting • Development of Strategic Recruitment Plan. • Team consists of PI,CRC, and study staff as well as a REC Director and Recruitment Specialist. • 1 Hour session to identify study patient population, past recruitment methods, potential barriers and creative idea sharing (ad creation and placement ideas). • Discuss primary and secondary recruitment avenues to be utilized.

  12. Participant Recruitment Strategic Recruitment Planning Meeting (cont.) • Identify KEY inclusion and exclusion criteria to query the Research Participant Registry(Over 10,000 queriable) • Discuss and develop pre-screening tools for Recruitment Specialists. • Submit and secure necessary IRB approvals for techniques and materials.* • Ideally, to occur before enrollment period officially begins.

  13. The Recruitment Enhancement Core (REC) (For ICTS Reporting Purposes – REC impact)

  14. Successful Strategies • Utilize the REC – if only for a consult – as well as the Research Participant Registry to see if we can help jump start recruitment – it is all we do! • Before agreeing to execute a trial, perform a Front-End Feasibility Analysis to see if the trial is feasible and funded appropriately. • Budget adequate? Potential population of participants available? Competing trials? Will you need outside support? Have a form that you can fill out as a guide – Have the REC involved with the Pre-Site visits to ask recruitment questions. • A focused, targeted recruitment specialist and strategic plan that is implemented and adjusted for return on investment can have a HUGE impact on clinical trial recruitment – a couple trials or a portfolio of trials. • Develop the plan early – be willing to review and update it for effectiveness – REC can help.

  15. Successful Strategies • Clinic and/or Hospital Database queries to identify potential participants. • Could be from PI’s (specialty) clinic or target population clinic – HIPPA considerations • Takes time and resources (All Scripts screening). • Always ask for advertising and recruitment support funds in your budget process – for grants, this can be partial or full FTE support – for Industry, ask for a flat dollar amount as a line item. • 20 -40% FTE or $5000/$5000 Recruitment and Advertising Support

  16. Successful Strategies • Have numerous avenues of recruitment going at once – waiting for the PI to identify patients may not always be the most efficient way to recruit. • Not all cost money – group info sessions, campus media and print, e-mail blasts to different groups, employee shuttles, clinic post cards, Medical Public Affairs collaboration, etc. • Collaboration with PI’s who do similar research – At Washington University or at other Academic Medical Centers on the protocol. • Seek out high enrolling sites for feedback • Be willing to set up monthly calls to collaborate, focused on recruitment • Experienced PI’s with targeted patient populations (media suggestions)

  17. The Recruitment Enhancement Core (REC) • Where are we going: • Young investigator focus – “JIT” funds from ICTS • Supplement recruitment efforts not budgeted for • Strategic partnerships with Industry Sponsors and CRO’s • Trial Placement from Sponsors (Quintiles and INC Research) • Clinic and Hospital Db reviews – • Medical Informatics and All Scripts • FTE support from PI’s and study teams • Billable Rates for selected services

  18. The Recruitment Enhancement Core (REC) • Where are we going (cont.): • Physician Referral networks – study by study • In the community or on campus • Intra Departmental Roundtables (Diabetes, Psychiatry) • NIH Low Enrolling Trial Support • RPR Database Upgrade • Retention Strategies and Surveys

  19. The Recruitment Enhancement Core (REC) • Facilitates more predictable and timely recruitment and enrollment • Allows for hypotheses to be tested most completely and most efficiently • Provides for attractive site selection to external sponsors knowing that recruitment is a priority in the competitive landscape of trial placement or grant awarding

  20. AcknowledgementSupported by theClinical and Translational Science Award (CTSA)program of theNational Center for Research Resources (NCRR)at the National Institutes of Health (NIH)Grant Numbers UL1 RR024992, KL2 RR024994, TL1 RR024995

  21. The Recruitment Enhancement Core (REC) Any Questions? Contact Information: Charles Rathmann 362-0897 rathmannc@wusm.wustl.edu 362-1000 (VFH Office)

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