Article · Volume 3, Issue 4 · pp. 325–326
Reporting of adverse drug reactions in clinical trials published in Indian Medical/Dental journals
Purav Mody1, Tamoghona Biswas2, Jaykaran Charan3, Deval Parikh3
- 1Postdoctoral Associate, Center for Outcomes Research and Evaluation, Yale University, New Haven, USA.
- 2Medical College Kolkata, India.
- 3Department of Pharmacology, Govt Medical College, Surat, Gujarat, India.
Abstract
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.
Keywords: Research Letters
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