|2004N-0181 - Critical Path Initiative; Establishment of Docket|
|FDA Comment Number :||EC36|
|Submitter :||Mr. Leslie Michelson||Date & Time:||08/02/2004 07:08:45|
|Organization :||Prostate Cancer Foundation|
| 5. Patient Recruitment: Many clinical trials are delayed due to the long and unpredictable process of recruiting patients. Some centers have demonstrated better performance than others. Perhaps there is a way to identify best practices that could be disseminated to other centers. In addition, as the major academic medical centers have increasingly concentrated on providing tertiary and quaternary care, a larger proportion of patients are being treated in community-based settings. Yet, it is often difficult to obtain the participation of community physicians in clinical research due to the steep learning curve to become a research investigator and the competing priorities of community physicians. We would suggest that the FDA consider ways to make it easier for community physicians to participate without compromising the rigor with which trials should be conducted and reviewed. In addition, most prostate cancer patients are diagnosed by urologists and may remain within the care of urologists for initial treatment. Yet, much of the research on treatments for advanced disease is conducted by oncologists. We believe that the FDA should consider exploring ways to help bridge this chasm in ways that reinforce both quality and continuity of care.
6. Inclusion and Exclusion Criteria: Many prostate cancer patients who participate in clinical trials have advanced disease and are elderly. Thus they have a relatively high incidence of co-morbidities. When clinical trials are designed with excessively restrictive inclusion and exclusion criteria, it becomes even more difficult to enroll patients and the results are even less reflective of the community for which the drug would be used. Thus, we believe the FDA should explore working with industry and academia to determine model sets of inclusion and exclusion criteria, perhaps based on disease stage and type of drug, to ensure meaningful results while minimizing unnecessary exclusions.
7. Combination Therapies: Most of the experts we have interviewed believe that the most effective treatments for prostate cancer will involve combination treatments, and that physicians will need to adjust those treatments over the course of the disease. Industry and academic researchers would benefit considerably from an effort to clarify the process for conducting clinical research on combination therapies and changing therapy based on results.
8. Knowledge: A striking aspect of the Critical Pathway Initiative White Paper document is the vast knowledge FDA collects in reviewing plans, protocols and data from hundreds of companies. While in many cases these observations result in formal Guidance Documents, we would like to see further dissemination of these observations. A ?no strings attached? stance by the Agency would be fine. But sponsors need this information acutely to avoid potentially time consuming and expensive regulatory errors.
In conclusion, we commend the FDA for its leadership in launching the Critical Pathway Initiative. It demonstrates the Agency?s commitment to improvement and to doing everything possible to expedite the development and marketing of safe and effective drugs, especially for diseases where the options are limited. We deeply appreciate the opportunity to present these comments and stand ready to support this effort in any and every way.