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Subject Screening, Recruitment, and Retention Tiffany Morrison, MS, CCRP Director, Clinical Trials Rothman Institute 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 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 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. 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” 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! 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 Example of a Screening log 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 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 emails/ phone calls, letters always help keep up compliance 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 Patient enrollment and the importance of education • • • • • Medications Medical conditions/ status Diaries/ drug or device compliance Study procedures Visit requirements 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 Retention Strategies 1. 2. 3. 4. 5. Maintain Communication Listen Be Convenient Maintain a Positive Attitude Know the Protocol Tips for Patient Retention 6. Patient Stipend 7. Reminder emails, letters, calls, text messages 8. Transportation Options