Once you have decided to participate in a clinical trial, you may have questions about what happens next. Here are some answers to help you know what to expect.

If I participate in a clinical trial, how am I protected?

Clinical trials seek to improve human health through the necessary process of human research. All researchers (doctors, participants) recognize the importance of protecting your rights and welfare. There are also strict federal laws governing human research:

All research projects involving people must be reviewed by independent committees to make sure that the participants are being protected.

Researchers must thoroughly inform patients about a study’s treatments and tests and their possible benefits and risks before a patient decides to participate in any study. This is called “informed consent.”

Where are trials conducted?

If you participate in a clinical trial, you might go to a large cancer center, a university hospital or your local medical center or doctor's office.

The trial may include people at one or two highly specialized centers or it may involve hundreds of locations at the same time. You would participate with the guidance of a team, including your doctor and other healthcare providers, who would report your experience during the trial back to the center responsible for the trial. Experts then use the information from all of the participants to evaluate what the trial is testing.

Why would I want to participate in a clinical trial?

Potential benefits of participating in a clinical trial include:

• Access to new drugs and treatments before they are widely available.
• Being among the first to benefit if a new approach is found to be helpful.
• Making a valuable contribution to cancer research.
• Helping doctors treat cancer patients more effectively in the future.

What are the risks of participating in a clinical trial?

Potential risks of participating in a clinical trial include:

• A new drug or procedure may have side effects or risks unknown to the doctors.
• A new drug or procedure may be ineffective or less effective than current approaches
• Even if a new approach has benefits, it might not work for you.
  

Who pays the costs of a clinical trial?

Most clinical trials are sponsored by a company, such as a drug or medical device company, or the U.S. government. Some trials are sponsored by private organizations. Usually, the sponsor  pays for the cost of the drug or treatment being studied. The sponsor also usually pays for any special testing or extra doctor visits.

"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests or X-rays that you would receive whether or not you were participating in a clinical trial. Some health plans do not cover these costs once you are in a trial, even though studies have shown that they are about the same as costs for patients who are not enrolled in trials.

Ask the staff at your health plan whether your insurance covers routine costs if you are in a trial. You can also check States That Require Health Plans to Cover Patient Care Costs in Clinical Trials to see if your state requires insurance to cover routine costs.

Because a lack of coverage for these costs can keep people from enrolling in trials, the National Cancer Institute is working with major health plans and managed care groups to find solutions. In the meantime, there are strategies that may help you deal with cost and coverage barriers. For more information, go to Clinical Trials and Insurance Coverage - A Resource Guide