Subject Screening, Recruitment, and Retention. Tiffany Morrison, MS, CCRP Director, Clinical Trials Rothman Institute

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1 Subject Screening, Recruitment, and Retention Tiffany Morrison, MS, CCRP Director, Clinical Trials Rothman Institute

2 Learning objectives List two sources of potential subjects who can be screening for enrollment Explain why it would be important for the IRB to review and approve advertising for clinical trials Provide examples of ways in which patients can be engaged during a clinical trial in an effort to retain them in the study

3 Patient Recruitment Paramount in conducting a successful trial Recruitment tips: Before committing, evaluate the enrollment criteria to see if they are realist for your site Develop a recruitment plan Be sure the entire team is committed Instill confidence in research subjects

4 Sources of subjects Chart review: pulling patients from the existing schedule of patients: normal patient population Database: using a diagnosis code or billing code to pull all patients that match within a certain time frame Referrals: some physicians can send out formal letters to PCP or other physicians that might see patients that match inclusion/exclusion Advertising: must be approved by IRB: can be google ads, newspapers, radio, etc.

5 Advertising Because it s part of the informed consent and subject selection process, all direct advertising must: Not imply certainty of favorable outcome Not over-promote compensation or benefits Not be misleading Not include claims of safety, efficacy, equivalence or superiority Include investigational Can t be termed new drug, new device

6 Subject screening The steps listed below are the industry standard for screening potential subjects: Determine subjects appear to match I/E to review: Medical history Medications Test/ procedure results Lab results Physical exam results Diagnostic exam results Review screening checklist: withdraw from meds, if necessary Never perform study-specific procedures before consent!

7 Screening visit and logs Most clinical trials require updated screening logs to be completed and sent on a weekly basis to the Sponsor Screening generally refers to patients whom have sign the informed consent form but have not met all inclusion/ exclusion criteria for enrollment

8 Example of a Screening log

9 Screening visit and logs Screening of patients is usually a fluid activity and can encompass up to 30 days prior to official enrollment into a trial This is due to numerous lab values, radiographic or imaging analysis, or surgical clearance Patients who sign a consent form but are not ultimately enrolled are termed a screen failure. Many studies limit the amount of screen failures that can occur at each site for budgetary and statistical reasons

10 Scheduling subject visits Good idea to create a subject tracker in excel or calendar. This usually has the allowable windows included so it s easier to make appointments within visit windows Make sure MRIs, infusion appointments, or anything else is scheduled with a reasonable amount of time between visits Reminder s/ phone calls, letters always help keep up compliance

11 Enrollment and Patient Retention Nearly 80% of clinical trials fail to meet trial timelines Kremidas, Jim. Recruitment Roles. Applied Clinical Trials Online. Sept.1, 2011 This includes recruitment and retention of qualified subjects

12 Patient enrollment and the importance of education Medications Medical conditions/ status Diaries/ drug or device compliance Study procedures Visit requirements

13 Patient Retention A CenterWatch report stated that dropout rates of 15%-40% are not uncommon, though the average is about 25% Common Reasons for Drop Out: Difficulty complying with the protocol dosages, timelines, or procedures AE/SAE Loss of motivation Peer pressure Financial constraints Disease improvement or lack of improvement

14 Retention Strategies 1. Maintain Communication 2. Listen 3. Be Convenient 4. Maintain a Positive Attitude 5. Know the Protocol

15 Tips for Patient Retention 6. Patient Stipend 7. Reminder s, letters, calls, text messages 8. Transportation Options