As we discussed in part I of our blog series on adaptive patient recruitment, the rare disease community is constantly striving to invest in developing new treatments. While there is a huge unmet need in this area, there are recruitment tactics that effectively provide support. Beyond the introduction of an early support program, which Jaime Cohen discussed in our previous post, there are additional strategies that can assist in higher recruitment numbers for rare disease. In part II of our series on rare disease we explore further.
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