This comprehensive database contains information on new cancer drugs in development, inclusive of pre-clinical research up to phase IV development. Following discovery, an experimental drug may take 12-15 years to get to market. Promising new agents first undergo pre-clinical testing in animals and are designated by the FDA as an Investigational New Drug (IND) if the pre-clinical data is positive. Research then moves on to human subject clinical testing through Phase I, II and III clinical trials.
Following an average of seven years of clinical trials the manufacturer may submit a New Drug Application (NDA) to the FDA if the data demonstrates both safety and efficacy for the specific agent. Once the NDA receives FDA approval, the FDA will issue official labeling and guidelines for administration of the drug.
The manufacturer may then make the new drug available to physicians to prescribe for patients. The manufacturer must continue to submit safety and efficacy data as mandated by the FDA. The FDA may also require post-marketing Phase IV clinical trials to test further formulations, dosages, durations and drug comparisons as well as long-term toxicity. If a manufacturer chooses to expand the approved indication, it must conduct new Phase II and III clinical trials.
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