Clinical Trials

Clinical trials are carefully monitored research studies. They test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.

Volunteers in one study group may receive a study-related treatment or drug, while other volunteers may receive a a different intervention. Dependent on the disease and type of trial, this could be the current drug treatment that is the standard of care or a placebo (a simulated treatment). You, your doctor and research staff may not know which treatment you are getting. Not knowing which participants are receiving the trial treatment allows the physician and research staff to objectively observe the volunteers during the study.

Treatments and interventions are generally developed by pharmaceutical and biotechnology companies or researchers and other experts.

Not everyone is eligible to participate in a clinical trial. Before joining a clinical trial, you must qualify for the study by meeting certain "criteria." These criteria can include age, gender, the type and stage of a disease, your previous treatment history and other medical conditions. The criteria are different for each clinical trial. Talk to your doctor if you are interested in participating in a clinical trial.

Participants in clinical trials should represent the patients that will use the medical products. This is often not the case—people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to medical products. To achieve health equity so all can benefit from clinical trials, we are committed to taking steps to change this. (Source: Clinical Trial Diversity - FDA)

Clinical trials take place in a variety of locations, including hospitals, universities, doctors' offices or community health clinics.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. The physicians, statisticians, patient advocates, and other members of the community that make up the IRB ensure the study is ethical and that you are not likely to be harmed. The IRB can stop a study if:

• It appears to be causing unexpected harm to participants
• There is evidence that the risks outweigh the benefits
• There is clear evidence that the new treatment is effective (If this is the case, the goal is to stop the trial and make the treatment more widely available)

There are both benefits and risks associated with clinical trials.

Joining a clinical trial may be beneficial if: 

• You and your health care provider believe a clinical trial may provide another option when standard treatments have failed. 
• You want to help test new or newly applied medical products or therapies.
• You want to help researchers find better ways to fight diseases.

Possible risks:

• There may be unpleasant, serious or even life-threatening side effects from treatment
• Treatment may not be effective for some individuals
• The study may require a lot of time for traveling to the study site, receiving treatments, or hospital stays
• Your health insurance may not cover all the study costs

You may withdraw from a study at any time, for any reason.