How many cancer patients participate in NCI-sponsored clinical trials?
Each year about 25,000 new patients enter into NCI-sponsored clinical trials. About 20,000 participate in Cooperative Groups, 5,000 in the CCOPs, and 2,500 in trials conducted at NIH in Bethesda, Md. This represents about 3 percent of adult cancer patients and about 60 percent of children who are diagnosed with cancer each year. Children under age 20 account for about 1 percent of all cancer cases. (http://www.cancer.gov/clinical_trials/ ) • What happens after Phase III trials? At the conclusion of the phase III trials, the results are reported at meetings and in peer-reviewed journals. If the treatment is proven safe and effective in phase III trials, the drug company sponsor of the drug files a New Drug Application (NDA) with FDA. The average time for FDA approval is six months to a year. Once approved by FDA, the drug becomes available for physicians to prescribe for patients. • About how long does the entire drug approval process take? It takes about 15 years on average for an expe
