A clinical study is an experiment that has been designed to prove a hypothesis:

  for example, that Drug A is as safe and effective as Drug B: that a drug’s pharmacokinetics remain unchanged in subjects with renal insufficiency; or that concomitant administration of an antacid with the drug has no effect on its absorption or other kinetic parameters. As with any other scientific endeavor, the conduct of a clinical study demands that good scientific methods be adhered to in order to ensure the highest quality results.

Over the past several decades, clinical researchers have developed standard methods that, when implemented in a clinical study, contribute to its smooth progress. These methods may include the use of recognized screening criteria for assessing subject eligibility such as the use of DSM-IIIR to categorize mental illnesses or the use of American Rheumatology Association (ARA) criteria for determining the extent of involvement in subject with rheumatoid arthritis. Other elements that add to the strength of the study include adherence to a well-defined clinical protocol, the selection of appropriate tests to assess safety and efficacy, the use of well- designed CRFs to ensure unbiased data collection, and the use of appropriately applied statistical applied statistical tests for the analysis of the data.

Collectively, these elements form the basis for the concept of GCP’s. Good Clinical Practices have been promulgated by the FDA with input from researchers, statisticians, clinical personnel, regulatory and legal specialists, and the pharmaceutical industry. They provide guidelines for essentially all aspects of conducting a well-designed and well-controlled clinical study. While it is the sponsor’s responsibility to ensure that a study conforms to the guidelines set forth, the CRC and investigator must also assist the sponsor in adhering to these guidelines.

The regulations and guidelines of GCP’s are detailed, and the reader should recognize that the elements described in this manual are rooted in these concepts. The Code of Federal Regulations CFR 21CFR Part 50, “Protection of Human Subjects,” and 21CFR312.50, Subpart D, “Responsibilities of Sponsors and Investigators,” describe in detail the regulations set forth by the FDA regarding the testing of drugs in humans..