Good Clinical Practice (GCP) is defined in the International Conference on Harmonization (ICH) guideline as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. This standard ensures that the rights and safety of the trial subjects are protected and that the trial results are credible.

A Brief History

ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) came into existence in 1996. However, there were a number of medical events and other legislative actions that led to the guideline we now refer to as ICH-GCP.

The first action taken by a government to control the way drugs were put on the market is the Pure Food and Drug Act of 1906, in the USA. In this law is stated the following: "An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and Liquors, and for regulating traffic therein". In short, it imposed regulations on the labelling of products containing alcohol, opium, morphine, cocaine and some other substances. On each product it needed to be indicated which substances were contained in the product and the quantity.

In 1937, a disaster occurred that proved that this Act was insufficient: the so-called Sulfanilamide incident in the US. Sulfanilamide was a product that was used in the battle against streptococci. It was sold as a child's syrup by dissolving it in ethylene glycol, also known as antifreeze (hence the disaster). As a response to this, the US government revised the Pure Food and Drug Act of 1906. This became the Food, Drug and Cosmetic Act of 1938. It introduced, besides stricter regulations on labelling, safety standards and required that new drugs were tested on safety before marketing.

The ICH GCP was developed within the Expert Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a joint initiative with experts from the regulatory authorities of Europe, Japan and USA, and from the pharmaceutical industry of the three regions as equal partners. Observers to this conference include experts from the WHO, European Free Trade Association, Canada and Australia. Expert working groups were created to draft guidelines on four main topic areas: quality, safety, efficacy and multidisciplinary. Since the inception of ICH, 37 guidelines covering these topics have been produced. The work under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.

Table 1 gives a list of relevant ICH Guidances. The ICH guideline 'Good Clinical Practice: Consolidated Guideline' (Efficacy 6) is widely considered to be one of the major achievements of the early phase of ICH. It has been incorporated into the European Union (EU) law and it is recommended that all investigators are fully familiar with its contents.