How Do Clinical Trials Work?

Clinical trials are in-human studies that are intended to evaluate the efficacy and safety of a particular treatment, device, or intervention. They are designed to help advance the understanding, management, and treatment options of a variety of health conditions.

Here’s how clinical trials work and how interested participants can find more information on joining the research process.

How do clinical trials work?

Clinical trials are usually the culmination of several years spent developing new therapies and approaches in research laboratories. The researchers involved in these studies must create a plan, called a protocol, that details how they plan to explore the effects of their proposed intervention in a human population. As part of this plan, they determine the length of the trial, participant eligibility requirements, any necessary tests and procedures, and the specific outcomes to be measured.

Before a study can begin, this protocol must be approved by an institutional review board (IRB), an impartial third-party organization made up of expert doctors and ethicists who evaluate study proposals and make sure any potential benefits of participating in the trial outweigh the potential risks for patients. This review process is in place to ensure all studies are conducted in an ethical manner and that the rights and privacy of human volunteers who take part are protected.

Before interested participants can enroll in a particular trial, the study staff must provide information about what participation entails, such as the potential risks and benefits. This is called the informed consent process and helps ensure patients are informed about the purpose of the study, any treatments involved, what information might be gathered, and how any data collected will be used.

In the case of treatment studies, once the trial protocol is approved, patient participants and researchers collaborate to find out the effectiveness of a specific intervention. The experimental treatment’s effects may be compared with a placebo (a sugar pill that does not contain any medication), or perhaps with a different drug already approved for use, to assess the effectiveness and safety of the potential treatment.

These studies are usually conducted in what’s called a double-blind manner, meaning that neither the researchers administering the treatments nor the participants know which patients are getting which intervention (i.e., the placebo or the study drug). This prevents any risk of bias, or errors that could potentially influence the study’s outcomes — either positively or negatively.