Clinical trials play a critical role in evaluating the effectiveness of medical, surgical, or behavioral interventions. They’re the go-to method when determining if a new vaccine, prescription medication, or medical device is safe and successful in its goals.
Clinical trials happen all over the world on a regular basis, but they’ve received increased coverage in 2020, due in part to the COVID-19 pandemic. Every year, more than 20,000 new clinical trials take place. To ensure that each trial is conducted safely and effectively, scientists and researchers must follow Good Clinical Practice (GCP).
You’re probably heard the term Good Clinical Practice, but what is it, where did it originate, and why is it so important? Keep reading to learn the answers to these and other related questions.
What is Good Clinical Practice (GCP)?
Good Clinical Practice is an internationally recognized ethical and scientific quality standard used to design, conduct, report, and record clinical trials that involve human subjects. It ensures that data collected during a trial is accurate and credible, and protects the integrity and privacy of trial participants.
Currently, good clinical practice is recognized by several jurisdictions, including the United States, the European Union, Canada, Japan, and Switzerland. The World Health Organization also promotes GCP and recently developed guidelines for implementation.
Where did Good Clinical Practice originate?
Good Clinical Practice originated in the aftermath of World War II. Specifically, it arose due to the Nuremberg Trials, a group of military tribunals intended to hold Nazis accountable for their war crimes.
Though the trials focused on an array of illegal activities, The Doctors’ Trial highlighted the horrific experimentation conducted on people imprisoned in concentration camps.
During the court proceedings, many of the Nazi doctors on trial said they carried out the experiments in the name of science. To defend their actions, they cited the fact that there were no international laws in place regarding human experimentation.
The atrocities committed by Josef Mengele and his associates encouraged the international medical community to take action. Two American doctors, Andrew Ivy and Leo Alexander, developed a list of qualifications for conducting valid, legitimate research. These qualifications were dubbed the “Nuremberg Code” and established a foundation for what we now call Good Clinical Practice.
In particular, the Nuremberg Code required explicit voluntary consent from people participating in medical trials and established guidelines to minimize patient risk while ensuring safety.
What is the Declaration of Helsinki?
In 1964, 17 years after the creation of the Nuremberg Code, the World Medical Organization established its own set of testing guidelines, called the Declaration of Helsinki. You can read the entire document here, but its basic goal was “to provide guidance to physicians and other participants in medical research involving human subjects.”
What is the Belmont Report?
Another important document that helped establish Good Clinical Practice was the Belmont Report, a paper issued in the spring of 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioural Research.
The Belmont Report established a set of three important principles to ensure ethical research, including:
1.) Respect for persons. This principle acknowledges that every clinical trial subject has dignity and autonomy. It requires anyone conducting a medical trial to receive written consent from each participant or their legally authorized representatives.
2.) Beneficence. This principle ensures that medical research focuses on patient benefits while minimizing harm. All medical research presents some risk, but it’s important that these risks are reasonable when compared to the expected benefits.
3.) Justice. This principle ensures that all of the people who participate in medical trials are recruited and treated fairly. It allows people of all ages, races, and genders to enroll and participate in clinical trials.
When did the ICH-GCP enter the picture?
The Nuremberg Code, the Declaration of Helsinki, and the Belmont Report established a foundation for good ethical practices in clinical research, but inconsistencies between different countries remained.
To create a consistent, easily repeatable set of directions, the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released a set of efficacy guidelines. These guidelines provided a comprehensive set of international standards for ethically conducting clinical research.
In addition to providing a new set of internationally recognized rules, the advent of ICH-GCP has increased ethical awareness, improved trial methods, and ensured high-quality data. Perhaps even more important, is the ability of Good Clinical Practice to bring medications, immunizations, and medical devices to the public much sooner.
If you’re interested in learning more about the history of good clinical practice, check out this slideshow from the Food and Drug Administration (FDA) or this article from Nuclear Medicine Communications.