BOX 3-1

Potential Contributions of Regulatory Science to Cancer Therapy

Ellen Sigal, Chair and Founder, Friends of Cancer Research, suggested key areas in cancer care that stand to benefit from increased regulatory science capacity at FDA:

  • improved clinical trial design, reflecting consideration of cancer as a set of multiple diseases;

  • validation of biomarkers to better match clinical trial treatments with appropriate patient populations;

  • availability of standardized metrics—beyond toxicity—for quality of life/symptom management;

  • evaluation of combination therapies;

  • advanced study of chemoprevention; and

  • additional stem cell research.

ing regulatory needs. DeLauro suggested that this characterization of the agency reflects a common public sentiment.

Although FDA has unique opportunities to improve the public health through its access to a diversified workforce and a wealth of data, accomplishing this goal is a daunting task. According to Drazen, a key challenge is that the agency is often forced to “take limited data … based on small numbers of people’s response to a given therapeutic approach—and determine what will happen when this therapy is unleashed to very large numbers of people.”

Another challenge faced by FDA is the rapid emergence of new technologies. A theme among the speakers was that the agency currently is not supported sufficiently to deal with the masses of data that come from large investments in such areas as genomics and health information technology. At the same time, emerging technologies cannot meet the demand for new therapies without coordinated effort from regulatory bodies. The presentations summarized below focused on specific areas of emerging technology and the scientific gaps caused by the lack of strong regulatory science. Box 3-1 lists some ways in which regulatory science could contribute to the development of therapies in the specific area of cancer treatment.



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