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Patient involvement in the approval of new drugs

Patient can contribute to the drug development and approval process by enrolling themselves in clinical trials. Participating in clinical trials not only contributes to improvements in cancer research and treatment but also allows enrolled patients access to closely monitored care and regular reviews on the status of their disease. The FDA has launched two programs to seek patients’ involvement in the drug development and approval process.

FDA’s Cancer Drug Development Patient Consultant Program seeks to include the views of patient advocates, as relevant to the drug development process. In meetings (via phone), selected patient advocates interact with the FDA and drug companies and carry out discussions on the different areas of the drug development process.

The Patient Representative Program provides cancer patients with the option to participate as a patient representative in the advisory committee meetings. A patient representative is expected to provide insight on problems, issues and /or questions, as considered important and relevant to the patient and their family members. A patient representative is required to meet several different qualifications, and those designated as voting members should be assigned the status of special government employees.