PHARMACOVIGILANCE IN CLINICAL TRIALS
Dr. Jay Kumar Sharma*
Pharmacovigilance has become an important tool for evaluation of adverse drug reactions (ADRs). During a clinical trial, ADRs can happen in any phase therefore strict vigilance is needed for the safety of the participants. Even after the drug has been approved, the effect of the drug has to be monitored in the larger population as during the trials, the study population is small and trial is under strict control due to robust inclusion and exclusion criteria. Once out in market, the medicine is consumed by a larger population, therefore the chances of occurrence of rare adverse effects are high. Due to this reason, Pharmacovigilance is very crucial even after approval of a drug. Lastly, in case of vaccines, AEFI surveillance and reporting is very important to find out the rare side effects of vaccination.
[Full Text Article]