Elements of Clinical Study Design, Biostatistics & Research

Clinical Research

Author(s): S.S. Patel and Aditya Patel

Pp: 71-88 (18)

DOI: 10.2174/9789815123791123010008

* (Excluding Mailing and Handling)


The clinical trial could either be an Explanatory Trial/ Randomised Control Trial (RCT) or Correlational Trial/ Pragmatic Trial. For developing new molecules as a drug, RCTs require human studies conducted in 4 phases called Phase I to phase IV of clinical trials. Pragmatic Trials are Correlational Trials. As such RCT & Pragmatic Trials are not dichotomous, there is a continuum. A PRECIS has been developed to assess the said trials. The reverse pharmacology approach is recommended to generate scientific evidence to make herbal drugs more efficacious & safe. These aspects are elaborated on in this chapter. 

Keywords: Clinical trial phases precis, CONSORT, Randomized control trial (RCT), Reverse pharmacology.

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