2004N-0181 - Critical Path Initiative; Establishment of Docket
FDA Comment Number : EC35
Submitter : Mr. Leslie Michelson Date & Time: 08/02/2004 07:08:37
Organization : Prostate Cancer Foundation
Consumer Group
Category :
Issue Areas/Comments
We have joined Faster Cures in the thoughtful comments they have prepared and submitted and wish to submit additional brief comments that focus on issues of particular importance to the prostate cancer community. We recognize that some of these comments may address issues beyond the purview of the Critical Pathway Initiative or the FDA but we nonetheless are providing these comments in the hope that they will enable the FDA to determine its course of action in the context of a broad understanding of the issues and relevant environment.
1. Surrogate Endpoints. The most important thing the FDA could do to help accelerate prostate cancer research would be to identify surrogate endpoints that would enable researchers to design trials with more proximate and measurable endpoints. We commend the FDA for its efforts already in this regard and would strongly encourage the agency to continue along this path.
2. Clinical Trial Design: The design of clinical trials to assess the efficacy and safety of drugs to treat prostate cancer is quite difficult, in part due to the endpoint issue addressed above. Determining what stage of the disease to include in the trial, determining the proper endpoints, and developing proper evaluation plans are all challenging for prostate cancer researchers. We believe that the FDA should stimulate more collaborative efforts to develop better clinical trial designs. We applaud the Oncology Division of the FDA for its recent initiative to define proximate endpoints for prostate cancer clinical trials. Translating these initial dialogues into practical guidance for the design and conduct of trials is the next step and we encourage the Agency to pursue this step aggressively.
3. Institutional Review Boards: We all benefit from the oversight provided by IRBs to ensure that human subjects receive the protections to which all humans are entitled. Yet, we believe that it may be time to review this system to see if there are alternate ways to improve it, especially when it comes to trials being conducted in multiple academic centers. We have been advised that it can take months and even longer to get multiple independent IRBs to approve a trial even when the matter about which there may be disagreement may be relatively minor. To be sure, any exploration in this realm should not run the risk of limiting the protections for human subjects.
4. Legal and Contracting: Many trials being undertaken in academic centers are delayed due to the lengthy and uncertain process of negotiating contracts and conducting legal reviews. These reviews typically focus on issues related to liability and intellectual property. It may be that standardized clauses to address these issues could be developed that would simplify and accelerate these reviews.