Patient enrollment continues to be a huge challenge in the clinical research industry. While there are plenty of ways sites can predict more accurate enrollment numbers and approaches for sponsors to help sites with accrual estimates, it’s just as important to actively track enrollment progress throughout the study.
In this excerpt from the free eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials,” we share a few ways to monitor patient enrollment over time.
Tracking enrollment performance: what sponsors/CROs can do throughout a trial
Once the trial is open to enrollment, sites must work to hit their targets. Sponsors can monitor enrollment performance across sites to watch for any trends that may emerge. The data can help answer questions such as:
- Do you need to add more sites to enroll more patients?
- Are there delays beyond the target enrollment completion date for most sites?
Ask sites to track screen fails and provide insight into reasons why more patients aren’t enrolling. If many sites are having problems enrolling patients for a particular study, look at the reason why. It might not necessarily be a site problem. Finally, recognize that it’s okay if a site is starting slow on enrollment, as long as they avoid mistakes and can ultimately reach enrollment targets.
Monitoring enrollment progress: how sites can stay focused during a study
Sites can monitor their own performance once they are open to enrollment and see whether they are on track to meet their goals or need to intervene. For greater insights, track recruitment/enrollment sources and reasons for screen fails to let sponsors know why enrollment isn’t going as well as planned. Captured information, such as why promising patients aren’t enrolling or reasons for dropouts, should be communicated back to the sponsor so they are aware of larger issues with the protocol. It may end up being a sponsor issue, rather than your individual site’s poor performance.
If the sponsor indicates other sites do not have the same problem, ask for help to either connect with other sites on the trial or identify best practices that can help your site be more successful in the problem area. This will not only be a learning opportunity for your site, but will also help the sponsor better understand the nature of the problem and position them as a collaborator to help address the issue.
Closing the loop: using past enrollment metrics to predict the future
After the trial is over, analyze the information you tracked throughout the study to see if predictions matched realities. Ultimately, this information can be used for future trials to increase the accuracy of enrollment estimates.
Sponsors can analyze enrollment trends across sites to assess whether they should add more sites from the beginning in order to enroll enough patients, adjust the I/E criteria and use any other actionable takeaways for future trial design and enrollment planning.
Sites can learn from past performance data and use the information when considering future trials and estimating enrollment.
The practices above can help sites and sponsors monitor accrual and make better predictions. For more tips on patient enrollment and other ideas that can helps sites and sponsors improve their partnerships, download the eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials.”