GCP Guidelines



Pharma IQ
08/26/2010

 

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Good clinical practice (GCP) guidelines, as approved by the International Harmonisation Conference (IHC), are internationally recognised standards used in clinical trials which involved human subjects. GCP guidelines provide an ethical and scientific quality standard for the designing, conducting and reporting of such medical trials

Further to protecting the human subjects participating in important medical research, IHC-GCP guidelines allow for the sharing of medical data and statistics across authorities in the United States, the European Union (EU) and Japan.

IHC approved GCP guidelines are accepted as the common standard for clinical trials in Australia, Canada, the Nordic countries and the World Health Organization.

Due to the increasing number of clinical trials taking place in Asia, clinical practice guidelines are also likely to be adopted by more organisations.

Currently IHC -GCP guidelines in Indiaare used by just 20 of the 150 contract research organisations in the country, according to a companiesandmarkets.com report.

As pressure mounts on pharmaceutical companies to get their products to market faster, it is essential that clinical trials are not conducted at the expense of good clinical practice.

Principles of IHC-GCP guidelines

GCP guidelines require all those conducting clinical trials to understand the perceived risks and balance these against outcomes.

The treatment of human subjects, each of whom must have given their prior consent, is placed at the heart of all trials taking place and the good practice guidelines state that this should "prevail over the interests of science and society."

A detailed protocol should be provided to show that clinical trials are "scientifically sound" and information must be recorded and handled in a way that can allow for "reporting, interpretation and verification."

GCP guidelines also contain provisions for the correct training of staff, citing that all medical care and treatment decisions regarding test subjects should be taken by qualified doctors or dentists and all those involved in administering any stage of the trial must have the suitable qualifications to do so.

GCP Guidelines FDA

Separate good clinical practice guidelines can be issued by individual states and in the United States the Food and Drugs Administration (FDA) has had its own regulations in place since the 1970s.

GCP guidelines in clinical trials from the FDA are managed through the Office of Good Clinical Practice (OGCP), which also deals with human subject protection. 

The OGCP advises the commissioner of the FDA on any issues arising within clinical trials which may have an effect on future policy, direction and goals relating to clinical practice. It is also closely associated with the bioresearch monitoring programme, liaises with a number of external government agencies and contributes to international collaboration on guidelines for clinical trials.

GCP guideline training and outreach programmes are also conducted through the OGCP.

Advancements in the pharmaceutical industry and new challenges mean the FDA regularly updates its guidelines for good clinical practice, details of which are available on the FDA website. 

Previous regulations include guidelines on consent of human subjects, which have been regularly updated since 1981.

Most recently the FDA announced an exception to rules on informed consent in 2006, which allowed the "use of investigational in vitro diagnostic devices...without informed consent in certain circumstances."

The change to the GCP guidelines reflects the need for swift identification of any "chemical, biological, radiological or nuclear agents" in the event of a terrorist attack or major health alert".
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