What is Clinical Research: -Clinical research in layman’s term refers to any study on human subjects conducted by pharmaceutical personnel in order to determine or authenticate the clinical and pharmacological properties of any investigational drug(s) and/or to discover any adverse reactions of such drug(s) and/or to study such investigational drug(s) with the purpose of estimating its safety and/or efficacy.
Similar to any regular scientific and research endeavor, clinical trials are conducted with an explicit objective through well- laid procedure and in controlled settings.
Clinical trials, in addition to individual country laws, are governed by well recognized guidelines and regulations at global level like ICH-GCP (Good Clinical Practice) guidelines, EU regulations and directives, guiding principle for Good Pharmacoepidemiology Practices, recommendations of World Medical Association Declaration of Helsinki etc. Most of the transnational corporations conducting clinical trials globally willingly and as a good practice tag on these recommendations and guidelines. These recommendations and guidelines primarily intend to protect the human subject from unwarranted risks in participating in a clinical study; enforce both voluntary consent to participate in research and the continual assessment of risk and benefit.