SUBJECT RECRUITMENT AND RETENTION AT THE TRIAL SITE

Pharma Admission

pharma admission

 

ABOUT AUTHORS:
Raj Kishor
Avigna Clinical Research Institute
Bangalore
raryan859@gmail.com

ABSTRACT:
Achieving clinical trial research participant recruitment and retention is essential for conducting a successful trial. Adequate enrollment provides a base for projected participant retention, resulting in evaluative patient data. Obtaining final evaluative data is dependent on successful patient and principal investigator retention. Patients cannot be retained without an initial pool of enrolled volunteers.

REFERENCE ID: PHARMATUTOR-ART-2027

INTRODUCTION:
Motivate the patient in participating the study? It has to be learned first, that is the challenge in clinical research industry. Here neither the sponsor, CRO nor the site staffs are taking the time to understand the patient. We eat food we like because it tastes good. Has the Sponsor, the CRO or the Site has ever asked the patient how the protocol tastes? One strategy or one size does not fit for all.


Differences in how effectively site enrolls or follow patients can skew the results and overly reflect the sites with the most data.

(NOTE): Despite more than two decades of focused attention and improvement efforts, patient recruitment and retention are among the largest challenges in clinical research enterprise is facing today and among the greatest contributors to delays in drug development.

RECRUITMENT: Is getting the attention of, and attracting potential research participants, i.e., “casting a net.”

RETENTION:  Research participants remaining in the study for its duration, to provide valuable data and attain study objectives.It is also referred to as “Attrition” (participants leaving the study prematurely and/or being “lost to follow up”).

VARIOUS STEPS INVOLVED IN RECRUITMENT PROCESS

  • Inclusion/Exclusion criteria
  • Adequately explaining the study
  • Recruiting an adequate and representative sample
  • Obtaining true informed consent
  • Maintaining ethical standards
  • Retaining participants until study completion
  • Minimizing cost-benefit ratio  and Compensation

THE VARIOUS METHODS OF PATIENT RECRUITMENT

  • Advertisements
  • Honest Broker System
  • Recruitment letters and/or scripts
  • Research registry
  • “Dear Doctor” Letters to encourage clinician referrals
  • General public interest news items on diseases or conditions -not study specific
  • Recruitment advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study
  • Newspapers, local papers, publications for parents, etc.
  • Television and radio
  • Posters, flyers: post around campus, in public spaces with permission if necessary.
  • Random digit Dialing (RDD) used in surveys and polling
  • Pop-Ups, banner Ads with required IRB approval

What after recruitment?
Once participants are recruited to participate in the trial, retaining them becomes a key to success.  All of the factors identified as important for recruitment are important for retention as well. A critical factor in retention is delivery on promises made during recruitment (e.g., that the burden of participation is low). Many factors need to be considered in developing a retention plan, including how long the patient is likely to return to the enrolling site. Maintaining ethical incentives for patient participation (ranging from newsletters to payments) is also important.The resources available for patient retention efforts should also be clear. Follow up rates can often be improved with more efforts; such as more attempts to contact the patient,but these efforts add cost.

STRATEGIES TO FACILITATE RETENTION:

  • Inquire the patient about barriers to participation “Why…and is there anything we can do?”
  • Flexible visit schedules like early morning, evenings and weekends
  • Access visit windows
  • Atmosphere of visit length of time spent in clinic
  • Diversions–magazines, DVDs and refreshments
  • Study staff and clinic staff interaction
  • Develop tools for your team and make it as easy as possible to conduct the study procedures especially for clinical staff
  • Communication with participants:  honest and frequent education enables an informed decision
  • Develop trust with the patients
  • Reminder phone calls and e-mails
  • Appreciation cards like –birthday cards, study anniversary cards and study tokens
  • Thank you letters at study close and share results if allowed

PITFALLS IN RECRUITMENT AND RETENTION:
Pitfalls abound in recruitment and retention.The most important of these pitfalls is the risk of selection bias.Targeting hospital or academic-based physicians and excluding community-based physicians.This is tempting because the former are often more accessible and is frequently more open to involvement in, and more experienced in, research projects.Another major pitfall is confusing terminologies.Materials that are translated into other languages must undergo strict quality assurance measures to ensure that terms are translated properly i.e. as it is in simple terms.

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