Retention in Clinical Trials – Keeping Patients on Protocols

Kristina Lopienski
June 1st, 2015

It’s no secret that patient recruitment is a key factor in ensuring study success, but too often retention is overlooked. In reality, keeping patients on protocols from start to finish can be just as challenging as recruiting enough patients in the first place. Patient compliance and retention are critical to the success of clinical trials. There are serious consequences of dropouts – from costly delays to missing data that can compromise the results and integrity of a study.

Despite good intentions of finishing a study, many participants end up dropping out for a variety of reasons. While some dropouts are due to uncontrollable circumstances, others are preventable. Of course, subjects have the right to discontinue participation in research at any time. However, when high percentages of dropouts are considered normal, it’s clear that more can be done to prevent withdraws.

The infographic below looks at the average dropout rates, reasons why dropouts happen, and solutions for better patient retention.

Infographic -Retention in Clinical Trials – Keeping Patients on Protocols - Subject Retention

It’s clear there’s a need for more effective ways to keep patients on protocols. While some dropouts will always be inevitable, it’s crucial to prevent both study delays and missing study data for regulatory submissions. When possible, understanding why a participant chooses to discontinue a study is valuable information to obtain. Their feedback may provide insight into what changes can be implemented to improve the patient experience.

Text Version

As if hitting target recruitment and enrollment numbers isn’t difficult enough, keeping patients on a protocol from start to finish presents its own set of challenges. Patient compliance and retention are critical to the success of any clinical trial, yet study volunteers occasionally drop out early and unexpectedly. Let’s take a closer look at patient retention in clinical trials.

How should we plan for dropouts?

The “Leaky Pipe” Analysis1

The “typical” funnel shows the process of patient participation and is used to identify gaps and find where to “fill the funnel” or “manage the leaks.” Industry benchmark data suggests that on average across all protocol phases and therapeutic areas, you need to identify ~10 patients to randomize 1. (The Leaky Pipe Analysis was contributed by Beth Harper of Clinical Performance Partners, Inc.)

Here’s an example of the funnel:

  • 100 patients identified or available move to the pre-screen step.
  • 31 patients are pre-screen qualified and move to consent.
  • 13 patients are consented and move to screening.
  • 9 patients are randomized.
  • 7 patients completed the trial.

Seven of 100 known patients from the top of the funnel complete the trial. 18% of patients randomized end up dropping out.

What are some common reasons dropouts occur?

Some common reasons are:

  • Inconvenient location
  • Schedule conflicts
  • Personal/family matters
  • Physically unable
  • Financial constraints
  • Lack of appreciation
  • Forgetting visits
  • Fear and anxiety
  • Condition not improving
  • Side effects
  • Refusal to comply
  • Misunderstood expectations

Or, the patient simply changed their mind (it is their right to do so). Multiple factors can play a role in one’s decision to drop out, and each patient has their own circumstances and motivations. Some of these factors are external, but others can be prevented.

How do patients who have withdrawn from a study compare to those who have completed one?2

Based on a survey asking study participants about their experiences:

  • 35% of patients who dropped out of a study early thought it was difficult to understand the Informed Consent Form compared to just 16% who completed the trial.
  • 64% of patients who dropped out of a study early were satisfied that their questions were answered during the Informed Consent Form discussion compared to 89% of patients who completed the trial.
  • 38% of patients who dropped out of a study early thought the site visits were stressful compared to 16% who completed the trial.
  • 47% of patients who dropped out of a study early said they were motivated by “myself” to stay enrolled in the study compared to 78% who completed the trial.

How well did the study meet those participants’ expectations?2

For patients who dropped out early, 24% said the study fell short of their expectations, 48% said it met their expectations and 31% said it exceeded their expectations.

For patients who completed the trial, 10% said the study fell short of their expectations, 27% said it met their expectations and 53% said it exceeded their expectations.

More than double the percentage of patients who dropped out of a study reported that it didn’t meet their expectations compared to those who completed it.2 More than half of patients who completed a study said it exceeded their expectations.2

What motivates patients to continue participation?3

Based on a survey asking study participants about their experiences, the following were motivating factors to continue the study:

  • 35% said the compensation they expected to receive
  • 34% said to keep their promise/commitment
  • 26% said the information they learned about their condition
  • 26% said the positive response to treatment
  • 26% said the free procedures and care they were receiving
  • 21% said the free study drug they were receiving
  • 20% said their relationship with the study staff

What can be done for better retention?

  • Minimizing burdens during protocol design
  • Set expectations up-front during ICF discussion
  • Explain importance of their participation
  • Promptly respond to inquiries
  • Send reminders for upcoming visits
  • Provide a comfortable and patient-friendly environment
  • Show appreciation and recognition
  • Accommodate their schedule as much as possible

When possible, try to understand why participants withdraw, and use that feedback to improve the patient experience.

Sources

  1. Beth Harper, Benchmark data from Clinical Performance Partners, Inc. and PhESi – 1998-2012
  2. https://www.ciscrp.org/wp-content/uploads/2014/01/2013-CISCRP-Study-Ineligible-Participants-and-Those-Who-Drop-Out.pdf
  3. https://www.ciscrp.org/wp-content/uploads/2014/01/2013-CISCRP-Study-Study-Participant-Experiences.pdf

What is your biggest challenge when it comes to retaining patients? Share your thoughts below.


Update (5/6/2019): This infographic has been updated to remove a stat referring to the average dropout rate for trials across the clinical research industry.

For tips on enrollment planning, determining trial feasibility and more, download the free eBook, “Patient Recruitment in Clinical Trials: Steps to Develop a Successful Enrollment Strategy

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