What Caused New Drug Trial Rules For France?

Clinical trials have been used for quite some time and nothing can compare to the findings of these studies. They allow medical professionals to study new treatments in a controlled setting. In these trials, medications and other treatment options are studied.

Patients with the focus condition of the trial treatment are able to use the studied protocol. During the trial, many things are considered and it helps create new and more effective treatment options for many different conditions.

In order to make these trials as safe as possible, the government as set guidelines. Unfortunately, the French government has had to take new measures to lower health risks of the volunteers following a study where one participant died and five others were hospitalized. Along with the new measures, the company who made the mistakes, Biotrial, was ordered to provide an explanation of how they will avoid repeating their fatal mistake.

During the Biotrial clinical trial, BIA 10-2474 was being tested. The medication was created to help with mood disorders, anxiety, and Parkinson’s disease. While 90 participants had no negative issues, it only took one death to cause the French government to reconsider their guidelines and work to create new drug trial rules. While Biotrial was in compliance as they ran their trial, the way they handled the death caused issues.

France’s health minister, Marisol Touraine, presented new drug trial rules. The plan included tighter rules that must be followed when completing human drug trials.

New drugs are being created all the time and having humans test them is a crucial part of the process of making them more effective. While the participants are chosen based on their certain conditions, no one is required to take part. Many times there is a nice compensation for those who do choose to take part in the research study. Having rules, however, keeps all participants as safe as possible while finding new and better treatment options.

In all areas of medicine, including those who are chiropractors and osteopaths, these rules must be followed. Failure to stay in compliance can cause consequences such as fines or even losing of licensure.

As you can see, clinical trials are a necessary part of creating new treatments, but it is crucial for those running the studies to follow the proper guidelines. Even when rules are followed, negative situations may arise, but they will be much less likely in research.