Best Practices in Clinical Trial Enrollment
An optimal approach for managing patient enrollment must include the ability to define feasible enrollment plans, track progress against it, and make informed corrections to the plan when needed. Following is a four-step, best-practices process for clinical study recruitment and enrollment:
- Plan
Every clinical trial begins with a plan. If you’re a study manager, you probably have several versions of an Excel spreadsheet to plan study enrollment. Multiple countries? Multiple spreadsheets. Life sciences companies have begun to use predictive analytics to forecast and visualize different scenarios so they determine the best course before taking action.
- Track
As a study manager, you track recruitment progress by gathering data from various source systems, like a CTMS. Whether you gather data manually or through an automated process in near-real-time, you must stay current to ensure clinical trial enrollment is on track. Most of the time, you enter these actuals from the CTMS into your enrollment spreadsheet to see how actual clinical study enrollment is tracking to the plan.
- Diagnose
Even the best-laid plans can run off course. Once you’ve manually updated all your spreadsheets, you must then quickly identify underperforming areas, such as countries and site investigators, so you can determine how to correct the plan.
- Optimize
Optimizing the plan is simple when you have a way of predicting where recruitment is headed. Then, you can model and implement changes to bring recruitment back on track. If you’re like most study managers, you might rely on gut feel to model these changes, or you might just throw money at the problem, hoping to recover in time. This final step in the process is critical to helping clinical trial enrollment finish on time.
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