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

2. 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

3. 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.

4. 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”

5. Determine subjects appear to match I/E to review:
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!

6. 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

7. 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

8. 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

9. Retention Strategies Maintain Communication Listen Be Convenient
Maintain a Positive Attitude
Know the Protocol

10. Tips for Patient Retention
Patient Stipend
Reminder s, letters, calls, text messages
Transportation Options