About clinical trials

What is a clinical trial?

Health authorities define clinical trials as “studies that are intended to discover or verify the effects of one or more investigational medicines. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible” (European Medicines Agency (EMA)).

A clinical trial must follow a strict set of rules outlined in the specific protocols related to the study. These rules establish requirements regarding, for example, which types of patients can be included in the clinical trial, procedures that must be followed and the number of required clinical study visits.

For additional general information regarding clinical trials, please visit the relevant websites of the EMA, the US Food & Drug Administration (FDA) and the US National Institutes of Health (NIH).

Why are clinical studies conducted?

Clinical trials are required for all new drugs because pharmaceutical companies need to demonstrate that the medications they produce are safe and effective before they can be made available to the general population.

Thus, a clinical study is designed to help researchers understand whether an investigational drug is safe and effective for humans. The main questions clinical trials researchers want to answer are:

 

  • Does this investigational drug work?
  • What side effects does it cause?
  • Do the benefits of the drug outweigh the risks?
  • Which patients are most likely to find this drug helpful?

Why participate in a clinical study?

Participation in a clinical study is always voluntary, and thus it is always up to you to decide if you and/or your loved one would like to participate. People take part in clinical studies for a variety of reasons, including the following:

 

  • There is no currently approved drug for their disease.
  • They have not experienced improvement of their condition after being treated with currently approved drug(s) or standard of care (SoC).
  • They want access to a new type of drug, even if it is not guaranteed to be better or as good as available drugs.
  • They would like to contribute to the development of a new drug for others with a similar disease.

Who can participate in a clinical study?

Among the requirements outlined by particular study protocols are those detailing which types of subjects can participate. These specifications might include the presence or absence of a specific disease, the way in which the disease was contracted and the age of the subject.

It is important to be informed, particularly if you intend to participate in a study, of the risks and benefits of participation, the informed consent process or questions to ask when considering your participation.

For additional information regarding clinical trial participation, please visit the relevant websites of the EMA, FDA and NIH.

How are participants protected?

In a clinical trial the rights, safety, dignity and well-being of subjects are protected and their interests are always the top priority.

For additional general information regarding the rights of subjects in clinical studies, please visit the relevant websites of the EMA, FDA and NIH.