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Clinical Trials

2. Introduction

Randomized clinical trials are scientific investigations that examine and evaluate the safety and efficacy of new drugs, devices, tests, or lifestyle interventions using human subjects.

The primary aim of most clinical trials is to provide an unbiased evaluation of the merits of using one or more treatment options for a given disease or condition of interest.

The results that these clinical trials generate are considered to be the most robust data in the era of evidence-based medicine. Ideally, clinical trials should be performed in a way that isolates the effect of treatment on the study outcome and provides results that are free from study bias.

A common approach by which to achieve this aim is through randomization, whereby patients are assigned to a treatment group by random selection. Patients and trial personnel are deliberately kept unaware of which patient is on the new drug. This minimizes bias in the later evaluation so that the initial blind random allocation of patients to one or other treatment group is preserved throughout the trial.

Clinical trials must be designed in an ethical manner so that patients are not denied the benefit of usual treatments. Patients must give their voluntary consent that they appreciate the purpose of the trial. Several key guidelines regarding the ethics, conduct, and reporting of clinical trials have been constructed to ensure that a patient’s rights and safety are not compromised by participating in clinical trials (Declaration of Helsinki, 2005; Altman et al., 2001).

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Altman DG, Schulz KF, Moher D, et al. (2001) The revised CONSORT statement for reporting randomized trials: Explanation and elaboration. Ann Intern Med;134: 663–94.