Articles and Information

What is a clinical trial or clinically-based research?

A clinical trial (also called clinical research) is a research study in humans to answer specific questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments (medications, procedures, or behavioral interventions) or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. (These are often called epidemiologic studies.)

What are the benefits and risks of participating in a clinical trial?

Benefits. Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

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

Risks. There are risks to clinical trials and they vary with the specifics of the trial.

• There may be unpleasant, serious or even life-threatening side-effects to treatment.
• The treatment may not be effective for the individual participant.
• Participation in the study follows a specific protocol of visits, testing, or procedures that may require more time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements. What should people consider before participating in a trial?
• People should know as much as possible about the clinical trial and feel comfortable asking the members of the healthcare team questions about it, the care expected while in a trial, and the cost of the trial.

Read next article on the drug evaluation process