As next steps, FDA indicated that the Opportunities List will be published in 2005. The initiative will continue as an ongoing effort with development of a formal process for continued input from all stakeholders.
Dialogue with outside groups will be continued and active collaboration for identified projects will be pursued. However, the agency has cautioned that a very real challenge will be the allocation of resources among short- and long-term projects.
Nevertheless, the agency announced that a few projects in the area of clinical trials and biomarker/surrogate marker development will be initiated in 2005 where consensus and resources exist. FDA also will look to collaborators to accomplish additional work.
These proposed projects, especially in the critical areas of clinical trials and biomarkers, may indicate priorities and goals to be announced in the Critical Path Opportunities List:
clinical trials Attention to the overall clinical trials process and approaches to streamline data collection and analysis are essential. Standardizing data collection and handling is an important first step.
Accelerating development and acceptance of novel trial designs which, although widely discussed, have not seen widespread use because of concerns regarding regulatory acceptance. Demonstration projects or guidances, or both, are needed to move the field forward.
Other goals include developing scientific consensus on certain methodological/analytical issues such as treatment of multiple end points and treatment of missing data in longer term trials; performing internal assessment of the clinical trials process through oversight of Bioresearch Monitor-ing and IRB inspections in all phases of trials; developing quantitative disease modeling and trial simulations for early drug development; and facilitating medical device development by improving pre- and post-market balance and leveraging outside expertise.
biomarkers Public discussion and consensus development on a general framework for investigating/accepting surrogate markers are needed.
Progress in pharmacogenomics as an example where sponsors can discuss data outside the review process, such as genomic data in concert with development of particular drugs, should be a goal.
Additional considerations include collaboration on specific biomarker projects, such as safety biomarkers, data mining projects, imaging as a potential biomarker, and evaluation of consortia in advancing the study of specific markers and surrogate end points (as discussed at the November 3 public meeting of the Clinical Pharmacology Subgroup of the FDAs Pharmaceutical Science Advisory Committee).
Extensive materials describing the initiative and progress made to date can be found at the key Critical Path web links listed in the Table. The December 3 webcast also provides insight into the agencys thinking on related issues, including the importance of improved communication with product sponsors to ensure the application of current best practices and efficient integration of new assessment tools as they become available.