Cancer treatment reports
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Cancer treatment reports · Oct 1985
Comparative StudyFood and Drug Administration requirements for approval of new anticancer drugs.
For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and comparative. ⋯ The study of cancer drugs in combination presents problems which are discussed. Drug firms are strongly urged to discuss the protocols with the Food and Drug Administration prior to initiating phase III comparative studies to be used for approval of the drug.