3 Questions to Ask About Your Clinical Trial’s Enrollment Performance

Ashley Toy
March 31st, 2020

Reaching accrual goals continues to be a top challenge in clinical research. Most studies double their original timelines to meet enrollment goals, and 48% of sites under-enroll study volunteers (Tufts, 2013).

To help steer enrollment performance in the right direction, we’re sharing three takeaways from our free eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.” Here are a few questions to ask for greater success with meeting accrual goals.

1. Have you revisited your enrollment estimate after the initial submission?

When submitting feasibility questionnaires, using past performance metrics to determine enrollment capabilities is critical to providing objective evidence of performance over an estimate alone. However, sites are often asked to provide enrollment targets when they only have a synopsis of the study.

Often, sites spend time on study start-up activities before they ultimately gain access to the full protocol document (which may not perfectly reflect the original synopsis). If the protocol has changed in a way that impacts enrollment potential – such as the inclusion/exclusion (I/E) criteria – sites should update the sponsor with a new enrollment number that accurately reflects these changes.

Sites should not be penalized for changing their numbers once they get the full protocol details, when they didn’t have enough in the first place. Stay organized, update estimates and track performance toward the new number.

2. Are you on track to hit enrollment goals?

Like the majority of sites and studies, the answer to this question may be no. Thus, you must figure out why your site isn’t enrolling more participants. Try to find the root cause of what’s making it more difficult than originally anticipated. Are there many screen failures? If so, be sure to track the reason for each screen fail so you can identify any emerging patterns; it might not necessarily be a site problem.

Is there enough time left to implement any proactive recruitment tactics to help get the trial back on track? Remember, it’s okay to start slow on accrual, as long as you ultimately reach enrollment targets.

To track enrollment performance, tools like Forte Insights help to provide immediate, actionable information into accruals, letting you:

  • Review which active studies are not on track to meet accrual goals
  • Instantly see which PIs to follow up with to improve enrollment performance
  • Make quicker decisions on whether or not to close protocols that haven’t enrolled any participants 
  • Identify which studies have high screen fail rates and need investigation 

3. What did you learn that will affect how you estimate enrollment for the next study?

A best practice is to evaluate if the study went according to plan. Were there inaccurate estimates or prolonged activities? The more trends you identify, the more you can use this information for future planning. Whether you achieved your target enrollment numbers on time or not, it’s critical to analyze performance and discover lessons to be learned.

To close the loop, sites should also give feedback to the sponsor, who can use that information when analyzing the following questions:

  • Did predictions match realities?
  • Were there any enrollment trends across sites?
  • Were there more sites added than originally planned in order to enroll enough participants?

This can help sponsors make better decisions for future trials and set appropriate expectations with the sites conducting them. The sponsor may realize they need to add more sites from the start in order to enroll enough participants or adjust the I/E criteria to be less strict.

Though it’s not always possible to anticipate, sites must be careful not to overestimate enrollment potential or commit to a trial that won’t be a good fit in the long-term. Using accrual outcomes from each trial, sites should accumulate past enrollment metrics to help better estimate future numbers and decide which trials to take on.

Learn More

The questions above can help with enrollment planning and tracking, but that’s just the beginning. To see how a business intelligence solution like Forte Insights can help you better monitor accrual progress, register for our open demo on Tuesday, May 19 at 1:00 pm Central.