By Ray Tobey, Chief Medical Officer on Apr 18, 2018 9:00:00 AM
Tracking clinical trial performance as the study progresses allows you to measure how well it’s going and ultimately, its likelihood of success. Yet, a clinical trial can have hundreds of tasks, so measuring each is an arduous, and some might say, an impossible undertaking. So, we wanted to boil it down to three main indicators that you may find as helpful metrics to help determine the pulse of your clinical trial.
If you are unable to satisfy these ‘requirements’ it doesn’t mean your clinical trial will fail, but certainly, it may be beneficial to take a deeper dive into understanding why you are not meeting these milestones and how you can prevent it from continuing or occurring again.
Adhering to recruiting timelines
This includes patients and investigators. It’s important to keep in mind that the number of days really depend on the type of trial. You cannot generalize and think that in all trials, it should take for example, 60 days, to recruit patients and 40 days to recruit investigators. If you manage your expectations appropriately and specific for a particular trial, you’ll be able to accurately determine how well your trial is proceeding.
Maintaining consistent team personnel
Keeping the same personnel throughout the trial is highly beneficial since protocol and guidelines can be quite complex. The longer someone is with a particular program, the more efficient and consistent the data intake will be. If personnel changes from the planning to the study start-up phase, this can open up new areas of conflict, misunderstanding and eventual disruption of overall success of the trial.
Project Manager preparedness
Each stage of the study has specific details to adhere to including regulatory and GCP (Good Clinical Practice) considerations. Moreover, changes to details change quite frequently. Therefore, measuring/testing your project managers understanding of these changes throughout the trial will allow you to gain a pulse on your clinical trial progress.