The Investigational Drug Branch (IDB) implements and monitors a comprehensive cancer therapy clinical contract program that sponsors clinical trials of novel anti-cancer agents that have demonstrated high activity in animals in the pre-clinical phase of the cancer therapy development program. IDB consists of the following two sections:
Developmental Chemotherapy Section
- Develops drug development plans, including Phase I, Phase II and Phase III trials, for anti-cancer drugs and coordinates with both intramural and extramural investigators and the pharmaceutical industry in the design and the conduct of these trials.
- Monitors clinical trials of anti-cancer drugs for safety, efficacy, and clinical pharmacology.
- Investigates and prepares reports concerning adverse events (AEs) for all INDs.
- Provides annual reports to FDA on oncologic drugs
Biologics Evaluation Section
- Develops drug development plans, including Phase I, Phase II and Phase III trials, for biological response modifiers and coordinates with both intramural and extramural investigators and the pharmaceutical industry in the design and the conduct of these trials.
- Monitors clinical trials of biological response modifiers for safety, efficacy, and clinical pharmacology.
- Investigates and prepares reports concerning AEs for all INDs.
- Provides annual reports to FDA on biological agents.
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