Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 42

Once sufficient data has been assembled to support administering the investigational drug product to humans an IND is filed and barring FDA placing it (the IND) on hold, human studies begin. It is at this time, the GCP expectations come to the fore and are the subject matter of this text.

Once a firm has received approval of a new drug (or Biologic) they may decide to set aside most if not all clinical trials involving the product unless Phase IV trials have been ordered by the FDA. Of course in many cases, clinical trials are continued for a product and those trials whether ordered by FDA or not must be conducted in conformance with IND regulations and GCP expectations.

Post approval use of the product by the medical professionals is not governed by the FDA or GCP, at least not in any formal manner. States and local jurisdictions oversee activities associated with the prescribing of drugs by physicians and other health care professionals via their professional licensing programs. The Federal Food Drug and Cosmetic Act contains language which translates into FDA keeping its distance from the practice of medicine or regulating professional practices.

GCP is therefore only a part of the GXP regulatory scheme which is embedded in the drug development continuum. It represents a still evolving portion of the culture of quality that has been evolving in the clinical development arena for some time. It of course only applies to the authorized human biomedical clinical trials which are conducted to generate data of safety and efficacy but those are the trials where data integrity and subject protections are most important. Interestingly the FDA has not adopted the ICH E6(R2) as a formal regulatory requirement as have a number of foreign regulatory authorities. However, the FDA played a leading role in the development of the ICH E6 (R2) standard and references ICH GCP (R2) in several key spots of the governing investigational drug regulations. So the FDA certainly agrees with GCP and its use in guiding human trials. FDA refers to its regulations governing investigational drug studies as being GCP. Admittedly much of what is contained in ICH E6 (R2) was drawn from the FDA’s existing regulations.