A clinical trial is a research study involving human volunteers to answer specific health questions. Many clinical trials are conducted to determine if a new drug or device is safe and effective for people to use. Other clinical trials compare existing treatments to determine which is better. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.  

Clinical trials are conducted according to a plan, or protocol, and follow applicable rules set by the Food and Drug Administration (FDA). The FDA establishes strict guidelines to make sure that people who agree to be in studies are treated as safely as possible.

If you are considering volunteering for a clinical trial, you should discuss the study with your physician to learn as much as possible. Some people participate in clinical trials because they have exhausted other treatment options. Other people participate in trials because they want to contribute to the advancement of medical knowledge. Before volunteering you should also know that there are associated benefits and risks. 

Potential Benefits 

Participating in well-designed and well-executed clinical trials is one approach for qualifying patient volunteers to:

• get actively involved in their health care
• gain access to potentially new research treatments and expert medical care for the condition being studied
• help others by contributing to medical research

Possible Risks

While every effort is made to keep volunteers safe, there are generally known and unknown risks associated with clinical trials, such as:

• there may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.
• the treatment may not be effective for the participant.
• the protocol may require more of the participant's time and attention than a standard treatment. 

You can find information about current clinical trials being conducted by searching www.clinicaltrials.gov, an interactive online database, managed by the National Library of Medicine. For additional information about clinical trials visit the U.S. Food and Drug Administration website (www.fda.gov)

Sponsors recruiting sites for clinical trials please click here to review OCRI site qualifications and resources.  

• We conduct clinical trials to evaluate the safety and effectiveness of new medical devices and drugs before they are available for market use.