November 2011

About Author:Ratnadeep V. Ghadage.
Department of Pharmaceutical Chemistry,
Appasaheb Birnale College of Pharmacy, Sangli,
Maharashtra, India

ABSTRACT:
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Clinical trials examine the safety and efficacy of interventions, or treatments, in human subjects. This manuscript focuses on pharmaceutical clinical trials. The word subject is used deliberately here, since all participants in clinical trials are subjects, even if they are under the care of a personal physician, and therefore patients in that context, at the time of the trial. The pharmaceutical industry is now a more significant investor in clinical trials, but in addition to these opportunities, it is being challenged by the financial impact of managed care and medicaid regulations on academic medical-center revenues. Besides that, there is growing public concern about our systems for protection of human subjects, along with some conflicts. There are public expectations that clinical research will yield substantial advances in the health of the public. Once clinical research studies are completed and a drug has been approved for marketing by a regulatory agency, reports of the drug’s safety and efficacy will be published in the clinical literature. This dissemination of the results provides clinicians and research scientists with evidence of the beneficial administration of the drug.