Question

Guidelinrs for good clinical trails

Answer 1

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected. It was finalised in 1996 and became effective in 1997, but was not enforced by law at that time. The Medicines for Human Use (Clinical Trials) Regulations 2004 and the European Union (EU) Directive on Good Clinical Practice changed the world perspective , and compliance with GCP is now a legal obligation in the UK/Europe for all trials involving the investigation of medicinal products. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. The concept of the ‘good physician‘ dates back to the ancient world and it is evidenced by the Hippocratic Oath (460 BC). In the United States, the first landmark in the regulation of drugs was the Food and Drugs Act of 1906. This was a result of harmful and lethal drugs that could be bought across the counter just like any other consumer product. Some examples are ‘Grandma’s Secret’ and ‘Kopp’s Baby’s Friend’ which contained large doses of morphine, as well as ‘Dr King’s Consumption Cure‘ and ‘Dr Bull’s Cough Syrup‘ which contained morphine and chloroform . In 1938, the Federal Food, Drug and Cosmetic Act was enacted by the Food and Drug Administration (FDA) and for the first time, manufacturers were required to test drugs for safety and present the evidence of safety testing to the FDA prior to marketing.



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