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.
Who is eligible to participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Where are trials conducted?
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.
Who pays for the costs of a clinical trial?
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.