You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar years.
Beginning in the 1980’s, Europe began the push for harmonizing regulatory requirements, primarily to create a single market for pharmaceuticals at the time. More specific plans were developed at the World Health Organization Conference of Drug Regulatory Authorities in 1989.
The following year, an initial meeting took place in Brussels, Belgium where representatives of the regulatory agencies from the U.S., Japan, and Europe met to plan an international conference and discuss the implications and terms of what would become the ICH guidelines. It was decided that the topics chosen for harmonization would be Safety, Quality, and Efficacy which reflect the three criteria that are the basis for approval of new medical products. The purpose of the International Conference on Harmonisation would be to reduce duplicate, time-consuming, and expensive procedures needed to market new products internationally, while still protecting public health globally. The image from the History of Clinical Research Timeline associated with the ICH Guidelines is meant to symbolize the unity of the three nations that worked together to develop them.
The International Conference on Harmonization led to the release of one of the most important guidance documents in clinical research in April of 1996, the ICH Good Clinical Practice (GCP) Guidelines. The guidelines are intended to provide the medical research community with “an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects.” In doing so, they “provide public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.” The ICH Guidelines are organized into 13 general principles, which can be grouped into five main concepts:
We encourage you to download our History of Clinical Research eBook to better understand key moments in the history of clinical research.
Image Credit: Nicolette Capuano