Transcript Subject Screening, Recruitment, and Retention

Subject Screening, Recruitment,
and Retention
Tiffany Morrison, MS, CCRP
Director, Clinical Trials
Rothman 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:
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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!
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
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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