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Compliance In Focus
Posted by Scott Schisler on Thu, Feb 25, 2016

Did You Know WHO Published GCP Before ICH?


You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released anWHO_Guidelines_for_GCP 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 past couple calendar years.

Back in the early 1960’s, public perception of clinical research began to take a turn as talks and frightful images of the Thalidomide tragedy gained national news. In this case, Congress managed to pass new legislation to attempt to mitigate the issue (the Kefauver-Harris Amendment, respectively), but who couldn’t be left wondering “What’s the next terrible course of events that will happen?”

Realizing there was a major concern over the safety of investigational drugs and the clinical research process, the World Health Organization (WHO) saw an opportunity. They created a Scientific Group in 1968 to review and create principles and guidelines to correctly evaluate drug products.  Years later, the end result was a 1995 publication of Good Clinical Practice (GCP); a comprehensive guideline for designing, conducting, recording and reporting clinical research that still has applications today. One year later, in 1996, some of the same experts that created WHO-GCP, then published the International Conference on Harmonization (ICH)-GCP, the same tool in use for human clinical trials today. This tool can be implemented in any type of clinical trial, from drugs or biologics to device trials. 

The utilization of good clinical practice is the cornerstone for quality research and is routinely incorporated into industry-sponsored studies. GCP incorporates established international ethical and scientific quality standards for clinical research involving the participation of human subjects. Prior to 1995, there was no reference document that could assign the aspects of quality, integrity, and trust to a clinical trial; qualifications that must be present in order to gain sustained support internally from health and research organizations, and externally from the community and lawmakers.

The goal of the WHO-GCP was to be more of an informative tool for less experienced users, including regulatory agencies in countries where no other guidance was issued. The WHO-GCP being the first of its kind aimed to serve as a reference for regulatory authorities, sponsors, investigators and ethics committees in implementing good clinical practice standards in clinical research, thereby providing validation to research safety practices and data integrity. Both the ICH-GCP and WHO-GCP address: 

  1. Justification for a clinical trial and protocol
  2. Protection of trial subjects
  3. Responsibilities of investigators, sponsors and monitors
  4. Assurance of data integrity and product accountability
  5. The roles and responsibilities of regulatory authorities during the course of a clinical trial

These elements are crucial to a clinical trial and had they not been outlined as they were in this historical document, drug and device development would have had difficulty advancing. The ICH-GCP has stood the test of time, and for the first time after 20 years, changes are possibly underway with proposed revisions outlined by the new FDA draft guidance. Click here for more details on the draft guidance. 

IMARC monitors routinely incorporate GCP into their everyday practice as they work with sponsors, sites and study personnel. Additionally, IMARC teaches GCP formally through IMARC University where monitors, investigators, and research coordinators from all levels of experience can gain field knowledge and expertise.

Please share your thoughts on how you incorporate GCP in your everyday practice.

The History of Clinical Research

 

 

 

Topics: Good Clinical Practice, World Health Organization, History of Clinical Research, IMARC Research, International Conference on Harmonization

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