Each and every review of a draft protocol by a study team, legal department, medical group, or regulatory agency is a test. Throughout this process it is easy to lose sight of what may well be the ultimate test of all – just, what does a protocol mean to a potential patient?
Analyzing a protocol from a patient recruitment perspective is imperative. When completed early in the protocol development stage, it can mean the cost-efficient addition of “patient-friendly” components that can significantly impact on-time enrollment. Consider the feasibility of:
- Minimizing patient time at study visits;
- Giving access to disease specialists;
- Offering an open-label option; or
- Providing concomitant medications or therapies at no cost