*Anjali Kadam, Rushikesh Ghule, S.A. Waghmare and Dr. Hemant Kamble


Clinical trials can be used to generate data on safety, efficacy, and/or effectiveness of treatments. They can be classified based on their purpose, phase, or design. Clinical trials comprise the portion of this endeavor involving human subjects. While the basic tenants of scientific inquiry do not differ from preclinical research, the stakes are higher and the regulations more stringent. The cost of conducting clinical trials can be measured in two ways: the human cost and the resource cost. The human cost is the cost from the patient’s perspective. The patient suffers from a condition dire enough that experimental therapy is a consideration. He or she holds out hope for this therapy and trusts to the scientific skill and integrity of those conducting the trial. The patients expose themselves to an incompletely understood therapy and usually suffer some degree of toxicity in order to gain uncertain benefit. Prior to a drug being declared useful or not, hundreds or thousands of patients may be involved in trials related to the drug. Sponsors and investigators have good clinical practice and regulatory responsibilities to which they must abide. It is prudent that individual clinical trials are designed, planned, and managed with the eventual goal of obtaining credible data to critically assess the benefit versus risk of IP. While drug revelation actually includes a component of luck, contemporary drug advancement is perpetually centered around components specific to a given infection. Much of the time, along these lines, an infection populace will have been focused on during preclinical turn of events. It ultimately depends on the clinical preliminaries interaction to evaluate whether the new specialist is both protected and successful in this or different populaces. For the most part, the first concern is surveying drug harmfulness and the related dosing and pharmacokinetics. Following this, some proof of efficacy is looked for. On the off chance that it is found, efficacy should be confirmed in bigger, randomized preliminaries. At long last, post marketing observation studies may be performed.

Keywords: Drug safety, clinical trails, clinical research.

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