Hidden Causes of Clinical Trial Retention and Compliance Issues

by Dan McDonald

This is the last in my three-part series revealing hidden causes behind delays in clinical studies. Part one is here, and part two is here. This final installment explores clinical trial retention and compliance.

Are you waiting too long to begin planning patient retention and compliance in your trial? We often say that retention starts with recruitment. How you recruit–more specifically, how and what you communicate and how you educate during the recruitment period–will directly impact your retention results.

Successful clinical trial retention and compliance are directly affected by the decisions you make very early–during the planning phase, while the protocol is still being drafted. It is critical to weigh the data desired against the patient burden right from the start.

Carefully consider these key participant concerns while planning your trial:

  • Number of visits
  • Frequency of visits
  • Length of visits
  • Procedures and their frequency
  • Education and justification to the participant so they understand why lengthy and/or painful procedures are necessary and vital for the research
  • Support available from additional individuals in the patient’s life
  • Impact of the study on the participant’s home and work life
  • Impact of the study on the participant’s loved ones

Understanding patient needs is an essential first step. While site personnel who run day-to-day practices for the target condition will be able to shed some light on the patient experience, you may have to go further. Hosting patient panels and conducting surveys of the target population can yield useful findings on what patients need so they will consent to participate and remain in the study on an ongoing basis.

Expectations: make them realistic

Once you begin recruiting and promoting your trial, fully educating potential study subjects is paramount. Let them know exactly what to expect by fully discussing the points in the list above. Even though this information is routinely covered during informed consent, patients sometimes underestimate the commitment, and once enrolled, their motivation to continue wanes.

Clinical trial retention

Retention is a constant effort, and even the most committed participants will benefit from retention tools to keep them motivated. These tools range from simple to more complex and commonly include:

  • Patient panels and focus groups to review and comment on study details surrounding their involvement
  • Comfort and activity items—a world of options are available. Examples of items Imperial has sourced for our clients and their patient volunteers include blankets, insulated bottles, cooler bags, slippers, note pads, tote bags, hygiene kits, and many more. While small in cost, these items go a long way to show your study volunteers that you care, that you’re aware of the challenges of trial participation, and that you’re listening.
  • Communication with participants through:
    • Patient newsletters
    • Technology, such as appointment reminders sent via text and study apps with study information
  • Appointment reminder cards
  • At-home study visits as an option (I say an option because many participants will tell you they prefer visits at the study site)
  • Meal provision during extended study visits
  • Reimbursement to cover travel costs for attending study visits

Keeping study participants informed, letting them know they are appreciated, and reducing cost burdens improve the participant’s willingness to stick with the clinical study.

Additional considerations for clinical study retention

Remember to budget for retention. More clinical operations professionals are building recruitment budgets, but retention is often not included. Consider allocating about 5 percent of your site per patient grants for retention strategies. Setting aside budget dollars now and putting centralized strategies in place will help avert costly challenges down the road. Remember to measure progress along the way and be prepared to adapt as needed. Clinical trials are living, breathing things and rarely go exactly how you planned.

And, of course–never pass up an opportunity to THANK your study volunteers.

Imperial Advantage

Even the most carefully planned and executed trial will face challenges. Imperial is ready to step in at any time to help, from study startup to all points following, including recruitment, retention, and closeout.

What are some of the most significant challenges you’ve faced with clinical trial recruitment and retention? How did you overcome those challenges? Scroll down and add your comments in the comment box below.


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