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Once you've decided that participating in a clinical trial could prove beneficial to you, there are other factors to consider that might affect your participation.
Each study has its own guidelines for who can participate, called eligibility criteria. To ensure the strongest results, researchers want study participants to be alike in key ways. Examples of eligibility criteria for a treatment trial might be a particular type and stage of cancer, age, gender, or previous treatments. The eligibility criteria are included in the study plan. To find out if you are eligible for a particular study, talk to your doctor or the doctor or nurse in charge of enrolling patients for the study.
If you were to participate in a clinical trial, you might do so at a large cancer center, a university hospital, or your local medical center or physician's office. The trial may include participants at one or two highly specialized centers or it may involve hundreds of locations at the same time. You would participate in the trial under the guidance of a team including your physician and other health professionals, who would report your experience during the trial back to the center responsible for the trial's overall coordination. Experts then use the information from all of the participants to evaluate the intervention that the trial is testing.
The trial sponsor usually pays for the cost of the intervention being studied (for example, any drugs being compared). The sponsor also usually pays for the cost associated with any special testing or extra doctor visits that are required.
"Routine patient care costs" are the usual costs of medical care, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., that you would receive whether or not you were participating in a clinical trial. Some health plans don't cover these costs once you join a trial, even though studies have shown that they are not appreciably higher than costs for patients who are not enrolled in trials. (See Cost of Clinical Trials.)
Ask the staff at your health plan whether your insurance will cover these routine costs if you enroll 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 has a law or an agreement requiring such coverage.
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, see:
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