Subject Screening, Recruitment, and Retention

Subject Screening, Recruitment, and RetentionTiffany Morrison, MS, CCRPDirector, Clinical TrialsRothman Institute

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 resultsReview screening checklist: withdraw from meds, if necessaryNever perform study-specific procedures before consent!

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 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. Maintain Communication2. Listen3. Be Convenient4. Maintain a Positive Attitude5. Know the Protocol

Tips for Patient Retention

6. Patient Stipend7. Reminder emails, letters, calls, text messages8. Transportation Options