Clinical Trial

The purpose of preclinical work–animal pharmacology/toxicology testing–is to develop adequate data to undergird a decision that it is reasonably safe to proceed with human trials of the drug. After satisfactory information has been collected on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted, clinical trials are conducted to evaluate its safety and effectiveness in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug.

Although the goal of clinical trials is to obtain safety and effectiveness data, the overriding consideration in these studies is the safety of those in the trials. CDER monitors the study design and conduct of clinical trials to ensure that people in the trials are not exposed to unnecessary risks.

Resources

On this page you will find legal and ethical regulations and guidance that the US FDA published for the clinical trial of drug development on:

Ethics Review

Regulatory Review IND

Phase I

Long-term /Reproductive Toxicity

In vivo Metabolism

Phase II and Phase III