Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs

Chapter 35

Good Clinical Practice (GCP)

David B. Barr

35.1 Introduction

The ultimate goal of most clinical investigations is to obtain marketing approval of the product. In the case of a drug product, the Food and Drug Administration (PDA) requires the submission of a New Drug Application (NDA) that consists of a compilation of all clinical and other test data from the clinical studies plus extensive information on the development, manufacture, and testing of the drug product. This document is often massive, running in excess of 100 volumes. The FDA reviews this information. The review often includes meetings with the sponsor and may include a request for additional testing by the sponsor.

Drug approval is for a specific drug, as well as the chemical entity, formulation, and the patient population on which it is approved for use, and the indications or disease state for which it is approved for use. For a sponsor to add other indications or patient populations to the drug labeling usually requires additional clinical studies to support these additional uses.

35.2 Human Rights and Protections

The need to protect human subjects during clinical studies is paramount, and the need for these protections is, in large part, based on abuses that had occurred in many countries including the medical experiments conducted by the Nazis and certain studies conducted in other countries without the full knowledge of the subjects.

The rights of the subjects in a clinical trial are based on the ...