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Living With Cancer

Advocacy

Process

New cancer treatments are developed through a sequence of experiments, first in laboratories and animals (preclinical testing) and then in patients (clinical trials). If the clinical trial results show that the treatment helps patients, the treatment becomes part of standard treatment.

This development of new cancer treatments is called the drug development process.

The relationship between clinical trials and the drug development process is complex. All development of new drugs is done in clinical trials; however, not all clinical trials are done to test new drugs. The clinical trials section has information specifically about clinical trials.

Two easy-to-read resources about the drug development process are:

The legal responsibilities of the FDA and the sponsor of an investigational drug are spelled out here: FDA policies and publications related to cancer

Drug Development Glossary

The FDA review of the drug company's application for the new drug uses many technical terms. Some of the most common terms follow:

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