Good clinical practices are a guideline to ensure a safe and effective outcome of all research experiments. The FDA give guidance documents such as information sheets for IRB's and investigators. Identify a FDA GCP example or document and describe the importance of this guidelines and its potential risk.
As a lab technician, it is one of those on-the-job training sessions you must put into practice daily. Good clinical practices (GCP) are the guidelines that are in place to ensure safety. The FDA sets the guidelines for any industry involving food and drugs that will be consumed by the public. It is a matter of public health and safety that all guidelines are properly conducted. According to World Health Organization (WHO), Compliance with GCP provides public assurance that the rights, safety, and well-being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. The responsibility for GCP is shared by all of the parties involved,
including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities, and research subjects.
Good Clinical Practices, as defined by the FDA on their website, are "laws and regulations that are intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects". The GCP's essentially have three main goals: Minimizing risk, protecting subjects, and ensuring adequate information about drugs are provided. I believe that the most important out of these three is adequate understanding about the drug's pharmacokinetics and pharmacodynamics. In order to maintain the safety of the subject and minimize the risks it is crucial to understand the interaction between the drug and the body, which is why I feel that this aspect of the GCP is the most important.
When learning about Good Clinical Practices (GCP) in this week’s lecture, I was reminded of a concept that I use daily as an engineer working in industry, which is Good Documentation Practices (GDP). Basically, GDP ensures that your organization is maintaining clear, reliable, and easily accessible records. I would imagine that these practices of good record keeping are very important when conducting clinical trials as well, because at the end of the day, if you didn’t record it, it didn’t happen in the eyes of the FDA. Something even as simple as recording the time and date can still be ambiguous, since there are many different time/date formats used globally. For instance, if I write 1/2/22, depending on the country, it can be read as January 2nd or February 1st. Even the year can be interpreted as 2022, 1922, or even earlier in time. This is why in my company we’re required to record the date by actually writing out the 3-letter abbreviation of the month and including the full year. “Jan 02 2022” is much more clear, and writing the date this way is a simple but effective method to prevent errors in data collection during a clinical trial.
One of the most important good clinical practices in the FDA documents I found was 21 CFR Part 50, which has to do with the protection of human subjects, namely informed consent. This is such an important concept to grasp due to the consequences of what can happen if not properly informed about the rights that each patient has. Famously, in the Tuskegee Syphillis experiment by the U.S. government, African Americans were being given Syphillis without their knowledge or consent in order to learn more about the disease and create a treatment. The people experimented on were not aware they were being lied to, and their rights as patients were not addressed. This led to numerous other human violations, but primarily, the study violated the informed consent of patients. With informed consent, the people would've known the consequences of the study, the objective of the study, and treatment options, among other things pertaining to the study. The people were not informed of any of their rights, and this led to distrust of the African American community toward the U.S. government, which even nowadays shows. As a result, many African Americans were given syphilis without any cure, and the consequences were their deaths. While the government found out about the disease, it cost human lives in the process.
