There are many good reasons to participate in a clinical trial. However, the decision whether or not to participate can seem daunting. People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them.
Participating in well-designed and well-executed clinical trials is one approach for eligible patients/volunteers to:
- Get actively involved in their health care.
- Gain access to potentially new research treatments.
- Have access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.
- Help others by contributing to medical research.
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. The FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.
For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, by removing medical variations that might complicate analyzing the results.
Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.