It’s important to understand what Good Clinical Practice is and why it matters. Especially if you are participating (or thinking about participating) in research.
Good Clinical Practice (GCP) is an international guide for how to conduct ethical and good quality research. GCP applies to all stages of research: design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of any research involving people.
GCP consists of 13 principles focused on the following:
- Safety
- You feel protected throughout the entire research study.
- Rights are Protected
- You have the right to information about the research.
- You decide whether or not you want to participate in the research.
- You have the right to withdraw from the research at any time without penalty.
- Your privacy and confidentiality will be protected.
- Quality of Research Data
- The data collected from you is for the purpose of the research and is based on a scientific protocol approved by an ethics committee.
Why do we need Good Clinical Practice (GCP)?
The idea of a “good physician” and “good clinical/medical practice” dates back to the Hippocratic Oath from about 400 B.C. This oath represents the earliest idea of medicine being practiced in a just and ethical manner. It established several principles of medical ethics that remain important today. These include the principles of “confidentiality,” “privacy,” and “doing no harm.”
While the oath itself was a good start, it was not enough to protect all of the people who participated in research from harm. Additional rules and regulations were necessary to help keep people safe.
The United States put into place the first legislation to help regulate drugs that are available over the counter, The Food and Drugs Act of 1906. Before this legislation, harmful and deadly drugs could be purchased by anyone, just like any other product. These unsafe products led to serious illness, injury, or death because the ingredients were not tested for safety.
Well known examples of drugs available at the time include:
- Kopp’s Baby’s Friend - contained a mixture of morphine and alcohol
- Dr. King’s Consumption Cure - contained a toxic mixture of chloroform, morphine, and pine tar
- Dr. Bull’s Cough Syrup - contained dangerous amounts of opium
In 1938, the Food and Drug Administration (FDA) approved the Federal Food, Drug, and Cosmetic Act. This was the first time manufacturers were required to not only test drugs for safety, but to also provide real-world evidence of that safety to the FDA prior to being available to the public.
The importance of Real-World Evidence
Real-world evidence comes from real-world data, and is evidence about the use, risks, and/or benefits of a medication, product, or treatment. Without real-world safety evidence, the product could not be sold. Companies that broke this rule could now be fined, sued, or even prosecuted by law if their products caused harm.
While research can be used to help people, the label of “research” has also been used across history to cause harm, particularly in times of war.
One of the most well-known occurrences was in World War II, when German physicians conducted horrific experiments on individuals in the concentration camps of Europe. These war crimes, performed under the banner of “research,” resulted in the development of the Nuremberg Code in 1947. This code is part of the reason research participants have the right to decide whether or not they want to participate in a research study.
Your voice and your choice matters.
GCP over time
Over time, new guidelines have been developed to better define the idea of ethical medical practice in clinical research. Unfortunately, nearly all of these guidelines were created in reaction to research that was harmful to participants or was unethical.
These guidelines include the Declaration of Helsinki (written in 1964, updated in 2013), the Belmont Report (1979), and the International Guidelines for Biomedical Research Involving Human Subjects (1982).
The primary goals of these guidelines are to protect research participants, allow people to participate in research when it can be helpful to the world, and treat all research participants equally and justly. As new research types emerge, like the use of technology or developments in genetic research, new ethical challenges arise. These documents help guide researchers through ethical challenges and define the principles within GCP guidelines.
How does the team at Evidation Studies ensure Good Clinical Practice?
From the design of our research studies to the final analysis of the information that’s collected, our research team holds each other accountable.
Our team is trained in GCP annually and attends discussions on the importance of Good Clinical Practice in human research studies. It is our guidebook for making sure our research is safe and the rights of our participants are protected.
Additionally, our research studies are reviewed and approved by an ethics committee called an Institutional Review Board (IRB), whose goal is to keep people safe and make sure research is done ethically.
We feel strongly about the importance of GCP because our participants are top priority to us.
Our mission is to encourage everyone to participate in better health outcomes. In order to fulfill our mission, we must provide a safe and educational experience for all of our research participants.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
