Reporting of adverse drug reactions in clinical trials published in Indian Medical/Dental journals

Every year, a large number of clinical trials studying pharmacological agents are published in the Indian medical/ dental Literature. Data on potential adverse drug reactions (ADRs) occurring during such studies needs to be presented in a standardized manner that is reproducible and facilitates an accurate comparison among these studies to form an informed decision on a particular pharmacological agent. The CONSORT (Consolidated Standards of Reporting Trials) group has emphasized on this important aspect of clinical studies by providing a separate supplementary checklist CONSORT “Checklist for Harm” for reporting detailed information on adverse drug reactions.[1]There is paucity of data on ADRs from clinical trials published in Indian Medical/ Dental journals. Thus, we reviewed the practice of ADRs reporting in clinical trials published in Indian medical/ dental journals in the last four years and critically evaluated them for deficiencies in reporting practices.