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Compliance In Focus
Posted by John Lehmann on Thu, Jun 17, 2021

3 Reasons Your Clinical Trial Fails To Meet Enrollment Targets


Many clinical researchers struggle to meet enrollment targets, especially over this past year.  There are many reasons, and some may be outside your team’s control.


However, with proper protocol development, site planning, and site selection, and accurate forecasting, you can mitigate some of these issues.

Here are three of the most common clinical trial enrollment challenges.

Protocol development

When you can’t find patients for your clinical trial, you might assume it’s due to a lack of interest. However, a recent study published in the Journal of the National Cancer Institute found structural and clinical factors are the most common reason why cancer patients don’t participate in trials.

The review of 13 studies involving 8,800 patients found 56% didn’t have a trial available at their institution, while 22% were ineligible due to enrollment criteria.

The research also discovered that when patients are offered the opportunity to participate in a clinical trial, they agree about half the time.

Good protocol development means accounting for many different factors that could impact enrollment, from eligibility to site selection.

Site logistical issues

Many sites experienced significant slowdowns due to the pandemic. While these challenges are likely temporary, other issues may be more systemic. For instance, sites that don’t have a reliable process for screening and enrolling patients may experience slowdowns.

Other sites suffer from miscommunication or poor project management.

Having well-trained personnel and the support of a contract research organization (CRO) to provide additional assistance as needed can help you avoid these issues.

Unrealistic enrollment targets

One of the biggest reasons for failing to meet clinical trial enrollment targets is setting unrealistic expectations from the start. Without an accurate enrollment timeline, you could be setting up your study team to fail.

Working with investigators during the protocol development process can help you ensure your enrollment targets and timelines are in line with real-world estimates.

Your study team should also feel comfortable challenging initial enrollment assumptions.

As you set your clinical trial enrollment forecasts, be sure to consider how many sites you’ll need to successfully execute the study according to your timeline and whether the study is feasible. You should also consider the best and worst-case scenarios.

Trial Enrollment

Set your trial up for success with accurate enrollment forecasts

As a full-service medical device CRO, IMARC has supported hundreds of trials and witnessed many enrollment challenges firsthand. We wanted to share what we’ve learned from experience to help your team set accurate forecasts and boost enrollment.

Our latest whitepaper offers practical recommendations for forecasting clinical trial enrollment, tracking and screening enrollment, and creating action plans when studies aren’t enrolling as expected.

We encourage you to download it and get in touch with us to learn more about how we can support your team at every stage in your trial.


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