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
Protocol evaluation from the patient’s viewpoint at the recruitment planning phase provides the cornerstone for effective tactical and creative implementation. The patient recruitment protocol analysis is a road map to successful enrollment and retention. When conducting a recruitment analysis, BBK probes for answers to such questions as:
- For whom is the protocol a treatment option?
- What motivates the target audience?
- What are the challenges in identifying and reaching these audiences?
- What aspects of the study design present opportunities versus threats to enrollment?
Just as the patient needs to understand the protocol in order to make a commitment, the sponsor should understand what may be driving the patient to participate. Successful marketers know their products. The protocol is the product; so why will a patient enroll in yours?