What is a clinical trial?
Who can participate in a clinical trial?
How does a clinical trial work?
What questions should be asked before choosing to participate?
What is informed consent?
What are the benefits and risks of participating in a trial?
What are some of the major central nervous system disorders studied in clinical trials?

 

While clinical trials may result in the development of medical therapies that offer better treatments and even cures for life-threatening and chronic diseases, there are risks involved.

Possible benefits for participants:

Play an active role in their own health care.
Gain access to research treatments before they are widely available.
Obtain medical attention at health care facilities during the trial.
Help others by contributing to medical research.

Possible risks for participants:

Possible unpleasant, serious or even life-threatening side effects to the experimental treatment.
The experimental treatment may not be effective.
The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

Does information remain confidential and private?

Access to personal information is usually available to the investigator and research team. In some circumstances, the Institutional Review Board (IRB) overseeing the research, the sponsor of the research or the Contract Research Organization (CRO) coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participants are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

What happens after the trial?

After a study phase is complete, the data is collected to determine the drug’s effectiveness—if it is safe and if there are any side effects. Depending on the results, researchers determine whether to stop testing or move to the next phase of the study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer review. Data then may be submitted to the Food and Drug Administration (FDA) for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies comparing the new drug—in terms of its safety, effectiveness and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.