Protocol of a Clinical Trial: Elements, Concerns and Potential Solutions

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Protocol of a Clinical Trial: Elements, Concerns and Potential Solutions

In the field of medicine in order to ensure better understanding of human biology and improve the health standards of the masses, conducting clinical trials remain a key approach. In general, all the randomized clinical trials essentially require a protocol to explain the rationale, adopted method, measures to ensure the safety of study participants, proposed statistical analysis, information about research funders, and organizational details right from the time of trial inception till reporting of the results. Multiple discrepancies have been identified in the clinical trials, and all of them have to be addressed to make research safe for humans.


In conclusion, the development of a comprehensive protocol not only provides a mechanism to ensure the monitoring of the trial throughout its duration, but also safeguards the interests of the study subjects and enhances the reliability of the clinical trial results. Protocol for clinical trials is preliminary and the most important step to reach to the decision of performing a clinical trial depending upon the scientific question for which answers are desired.


However, the decision to perform a clinical trial should be made after considering the magnitude of the problem for which clinical trial is needed; potential evidence available to suggest that newer alternative will definitely add to the existing knowledge; extent of anticipated benefits in terms of well-being/survival rate/cure rate/side effects; availability of a simple approach to perform the same; and ethically justifiable.


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