Every clinical trial has specific guidelines about participant qualifications. In order to standardize the test results, researchers use
inclusion/ exclusion criteria
such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. Inclusion and exclusion criteria are not used to reject people personally, but 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.
A control group of people often provides the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
When you learn everything you can about a trial and still decide to participate, you are giving consent to be studied.
Medical staff will strive to ensure that you understand the ramifications of the treatment protocol. The research team will provide you with a consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in the consent document. A consent form is not a contract, and every participant is free to withdraw from the trial at any time.
Clinical trials are not intended to replace on-going treatment with a primary physician. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. Your health care provider will work with the research team to ensure that the trial protocol will not interfere with your other medications or treatments.