Clinical trials toolkit

ABSTRACT

Clinical research aims to address the uncertainties that exist about treatments and interventions that are in use for a variety of diseases. This results in better choices for patients and more responsible decisions by physicians. Clinical research can also help in critical rediscovery of the causes of human disease and its prevention. During a clinical trial, newer treatments are tested from laboratory till therapeutic use with patients. In addition, the benefits and harms of existing treatments and interventions are also adequately relooked at. Prospectively randomized controlled clinical trials that reduce known and unknown biases, are the best way to reduce uncertainties about the relative merits and disadvantages of both new and existing treatments and interventions in order to provide better choices for patients. Clinical trials have been the focus of a number of controversies in the past. They have emerged from the dark shadows of World War II and the infamous US Tuskegee study with a firm commitment from the medical profession to always uphold the interests of the patient, above commercial and scientific gains. The spirit of the Helsinki Declaration framed and updated by the World Medical Association is expressed in the regulations governing and guiding the conduct of clinical trials, and has yielded best practice guidelines called Good Clinical Practice (GCP) guidelines. GCP specifies the desirable process of conducting clinical trials, spelling out in great detail the steps to ensure the ethical conduct, and to safeguard the interests of the patient or volunteers participating in the trial. However, in common parlance, the clinical trials still conjure up a picture of unethical experimentation especially when powerful pharmaceutical companies try to conduct them in countries with lax regulatory mechanisms.

KEYWORDS

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• DOI10.4103/0976-500X.95547Copy

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