Informed Consent for Clinical Trials: Is Simpler Better?

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Abstract
Randomized clinical trials are considered to be the gold standard for testing cancer treatments (1). A major difference between randomized clinical trials and the traditional practice of medicine is that, in clinical trials, the treatments offered are assumed to be of similar benefit for patients. The selection of which treatment they will get is made randomly, rather than individually (2). After a predetermined period of time, each patient group is compared, and the advantages (if any) of one treatment over another are examined. The ultimate benefit of the randomized clinical trial process is to advance knowledge and science. The trial itself may or may not benefit the individual patient. In this regard, randomized clinical trials are often antithetical to how everyday medicine is practiced, and the complexity of the trials has to be carefully explained to each participant. Every patient who takes part in a randomized clinical trial must be well-informed and must participate of his or her own volition (3). Making sure that patients are fully informed before they agree to be included in any randomized clinical trial has been, and continues to be, an immense challenge for all who are concerned with the ethical advancement of science (4).