Randomized Controlled Trials Informed Consent

Contr Outcome

Randomization Eligible patients

Informed consent view of study Ethics re JAMA lled trial Randomized contro ’s Web site at www.jama.com. Web ’s eatment Outcome Tr FOR MORE INFORMATION YOURSELF INFORM www.clinicaltrials.gov www.nih.gov www.cancer.gov Prevention www.cdc.gov was published in the June 4, 2004, issue; and one on supporting medical was published in the research September 21, 2005, issue. • National Institutes of Health • National Cancer Institute and • Centers for Disease Control JAMA Patient find this and previous To Pages, go to the Patient Page link on JAMA A Patient Page on cancer clinical trials . In such trials the participants . The information and recommendations recommendations and information The . process process The Journal of the American Medical Association Medical American of the The Journal (by chance, like the flip of a coin). This is JAMA random (a pill or procedure that does not include active ingredients). randomized controlled trials informed consent . in the United States). This is a JAMA trial, the investigators know the trial, neither the clinicians caring suggests suggests that you consult your This physician. page may be noncommercially photocopied by physicians and other health care professionals to share with patients. purchase To bulk 312/464-0776. call reprints, The JAMA Patient Page is a public service of of service public a is Page Patient JAMA The condition, medical appearing on this page are in personal appropriate most but instances, they are your not a for substitute concerning information specific For diagnosis. medical placebo treatment single-blind includes a review article about clinical trials. This Patient Page is based on one double-blind JAMA institutional review board (how well it works under optimal conditions) of the treatment. of the treatment. (how well it works under optimal conditions) (prejudice) for or against the treatment being studied. for or against the treatment (prejudice) bias PATIENT PAGE PATIENT efficacy who receive the treatment under study are assigned at edical research answers many questions about health, illness, and treatment options. Evaluating new medicines and other treatments may involve research using , March 24/31, 2010—Vol 303, No.12 24/31, 2010—Vol , March MA receive a standard treatment or

JAMA

PARTICIPATING IN A CLINICAL TRIAL IN PARTICIPATING RESEARCH ETHICS CLINICAL TRIALS CLINICAL sure it fits with your ongoing care. sure a clinical trial. choose. therapy or placebo. standard participants will receive understand whether control treatments, especially when they have a disease that has not responded to other especially when they have a disease that has not responded treatments, therapies.

controls The March 24/31, 2010, issue of previously published in the June 21, 2006, issue of M necessary to ensure that the outcomes are determined only by the treatment under study and not by other factors that could otherwise influence treatment assignment. Other participants who, by the randomization process, serve as 1216 Janet M. Torpy, MD, Writer Janet M. Torpy, MA, Illustrator Cassio Lynm, M. Glass, MD, Editor Richard Sources: National Cancer Institute, National Institutes of Health, Centers for Disease Control and Prevention and Control Disease for Centers Health, of Institutes National Institute, Cancer National Sources: • Participants should have all their questions answered before agreeing to participate in agreeing before • Participants should have all their questions answered thinking of joining a clinical trial, discuss participation with your doctor to be • If you are • All participants in clinical trials are volunteers who can withdraw from a trial if they volunteers who can withdraw from • All participants in clinical trials are the purpose and design of the study and • Participants should have the option to review to receive experimental • Sometimes participating in clinical trials may allow patients to receive The ethics committee reviews the purpose of the study and its design, the risks and the purpose of the study and its design, the risks and The ethics committee reviews adequacy of the informed consent process. possible benefits to the participants, and the an ethics committee (called an community members, who discuss all of the panel of individuals, including doctors and or hospital). medical center, studies at a specific institution (university, research proposed the influence of by approval clinical trial, the study must receive in a any persons can be enrolled Before active treatment until the trial is concluded (unless a medical problem requires that the requires until the trial is concluded (unless a medical problem active treatment a that). In before information be released against protect assignments but the participants do not. Blinding procedures treatment possible benefits of the trial and often includes a written form to document those possible benefits of the trial and often includes consent. In a issues and the volunteer’s know who has been assigned to the for the patients nor the participating volunteers the safety and the condition being studied, who meet specific criteria, including having Volunteers an explanation and, if they choose, join the trial. This receive assignment as well as the risks and should include explaining the random treatment Clinical trials are designed to answer a specific question about a treatment, usually designed to answer a specific question about a treatment, Clinical trials are Randomized Controlled Trials Controlled Randomized Downloaded From: https://jamanetwork.com/ on 09/26/2021