Johns Hopkins Institute for Clinical & Translational Research OFFICE OF RECRUITMENT AND RETENTION

1. Johns Hopkins Institute for Clinical & Translational ResearchOFFICE OF RECRUITMENT AND RETENTION Cheryl Dennison Key Features of a Recruitment Plan. Lessons from Marketing. October 16, 2009

2. “…the majority (nearly 80%) of clinical trials conducted in the US must extend enrollment by at least one month beyond the study completion period.” Getz, K. “Meeting and Extending Enrollment Deadlines.” PAREXEL Pharmaceutical R&D Statistical Sourcebook 2000. p. 104. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

3. Ensuring positive moments of truth Developing brand value Key Features of Recruitment Process. Lessons from Marketing. Gaining legitimacy/ prestige Providing frequent positive reinforcement Facilitating standard operating procedures I. Building brand values IV. Maintaining engagement Signaling worthiness III. Making the sale II. Product and market planning Engaging active sponsors, champions & change agents Providing simple, complete processes Devising strategies for overcoming resistance Delivering a multiaudience, multilevel message Achieving buy-in Adopting an explicit marketing plan The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009 Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48.

4. 5 Stages in “Marketing” a Trial • Set-up • Gaining prestige • Building robust systems • Market planning • Segmenting markets • Devising marketing story • Signaling • Conveying message • Enrolling patrons and sponsors • Learning • Developing market knowledge • Redirecting strategy • Reinforcing • Maintaining and renewing commitment The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009 Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48.

5. Where to Start???? • Critically review protocol with emphasis on enrollment criteria / participant burden • Identify possible sources of participants and strategies to engage them • Develop marketing message(s) / plan • Develop outreach plan • Prepare materials • Recruit and train staff • Plan to evaluate plan The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

6. Reviewing the Study Design / Protocol • Length of Study • What is the minimum duration necessary to see an effect? • Choice of Control Group • Use of placebo typically increases difficulty • Number and Type of Tests Performed • Blood draws • Procedures [colonoscopy, pelvic exam, x-ray, biopsies, surgery] • Medication withdrawal The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

7. Sampling Target Population Accessible Population Study Samples The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

8. Ideal Accessible Population • High risk for disease • Candidates for treatment • Representative of target population • Ethical considerations • Feasibility considerations • recruitment • follow-up • high quality data The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

9. Enrollment Criteria • Inclusion Criteria • Characteristics of accessible population • Exclusion Criteria • Considerations related to: • adherence • follow-up • safety • ethics The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

10. Potential Nonadherence Indicators At Enrollment • Concerns about randomization • Expectation for specific treatment • Concerns about medication side effects • Concerns about study task demands • No-show or rescheduled assessment appointments • Scored positive on blood alcohol concentration (BAC) on breath analyzer test at baseline interviews • Problems with detoxification • Unexpected social, occupational or health event The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

11. Developing a Recruitment Plan • Know your resources (human/financial) • Estimate # / month needed to achieve recruitment goal • Information needed • Start and stop dates, e.g., 12 months • Sample size, e.g., 240 • Yield from initial screening visit, e.g., 10% • Number of screening visits, 2,400 = 240/.1 • Number of screening visits per month, 200=2,400/12 The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

12. Developing a Recruitment Plan • Establish “brand” for study • Use multifaceted “marketing” approach • Select acronym and logo for easy id • Good Acronym (e.g., HERS, COACH) • Bad Acronym (e.g., ORP, BIRP) • Prepare key informational materials • Brochures, fact sheets, posters, pocket reference cards, video, podcast, stories, advertisements • Prepare or purchase other promotional materials • Pens, bags, coffee mugs, memory sticks, …. The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

13. Developing Recruitment Materials • Make materials appealing • Large fonts, interesting graphics, eye-catching message • Items to include • Major inclusion and exclusion criteria • Potential benefits and incentives • Contact information • Educate and engage potential referrers • JHMIRB guidance The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

14. Five Levels Of Potential Participant’s Commitment • Uninformed (inform and persuade with targeted stories) • Unconvinced (address concerns point-by-point; get to yes) • Laggards (enroll, cajole, facilitate and target) • Steady performers (reward, renew, upgrade and recognize) • Stars (honor, learn from, exploit and nourish) The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009 Campbell et al. Health Technology Assessment 2007; Vol. 11: No. 48.

15. Ongoing Recruitment Activities • Track and evaluate progress • Drop and add new strategies based on performance • Maintain rapport with referring physicians • Avoid perception that you are competing for patients • Refer participants back for medical care • Report abnormal findings and medical issues to primary care doctors The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

16. Tracking Recruitment • Record activity (contacts, visits) • Track the process in detail by • recruitment source or strategy, if possible • recruiter or staff person • time to return calls • Use flexible database software (e.g., Access) • Use reports routinely to guide decisions and allocate resources • Review progress frequently The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

17. Measuring Success • Recruiting method • # calls in / out • # appointments scheduled • # eligible • # enrolled • # trial completers • If possible, estimate: • Total costs of the method • Cost per enrolled participant The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

18. Office of Recruitment & Retention, 10/16/2009

19. Staff Recruitment and Training • Planning • Budget adequately for personnel and training • Hiring • Focus on interpersonal skills (phone, in-person) • Customer service • Strive for diversity (race-ethnicity, gender) • Training • Study disorder and its implications • Trial marketing message(s) • Recruiting goals, procedures, and regulations The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

20. Staff Retention • Motivate • Set personal recruitment goals • Acknowledge challenges and interim progress • Check in formally (e.g., staff meetings) as well as informally (e.g., view from the trenches) • Celebrate • Interim goals and end of recruitment The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

21. Advertising Your Study at Hopkins • Hopkins Ink • Kara Yeager, editor, 5-1396 • hopkinsink@jhmi.edu • Deadline is noon on Thursdays • Like electronic submissions • http://www.insidehopkinsmedicine.org/hopkins_ink/ • The JHU Gazette • 443-287-9900, gazette@jhu.edu • Free listing in notices • Deadline is noon on Mondays, 1 week prior to publication date • www.jhu.edu/~gazette • Digital TV ads • Melissa Schmelick, Content Manager, 4-6610 • Broadcasts your message on plasma TVs across the university • $50/month • Runs for 15 seconds each cycle The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

22. Office of Recruitment & Retention, 10/16/2009 Marketing Your Study Kathy Smith Director Market Development ksmith19@jhmi.edu 5-0088 (please state that you have been referred by the ORR) The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

23. Office of Recruitment & Retention (ORR) • ORR Consult Service (ORRCS): • Expert guidance to assist PI’s and Study Coordinators with: • Developing recruitment & retention plan • Troubleshooting plan that is not working • Boosting recruiting & retention rates • Contact us through ICTR Connection Request system at: http://ictr.johnshopkins.edu/connection • Select ORRCS to complete the form, which will be forwarded to us immediately The Office of Recruitment and Retention Lunch Lecture Series October 16, 2009

24. Office of Recruitment & Retention (ORR) • Contact Us: •  http://ictr.johnshopkins.edu/ORR •  5-9872