Volume : 13, Issue : 09, September – 2026
Title:
COMPARATIVE STUDY OF DATA SAFETY MONITORING BOARD (DSMB) PRACTICES IN INDIAN CLINICAL TRIALS VERSUS GLOBAL STANDARDS.
Authors :
G. Nithya*, G. Kamal Yadav
Abstract :
Data Safety Monitoring Boards (DSMBs) are independent expert committees established to oversee the safety of participants and the integrity of data in clinical trials. Globally, DSMB practices are shaped by international standards such as the International Council for Harmonisation (ICH) Good Clinical Practice guidelines and regulatory guidance from agencies like the U.S. National Institutes of Health (NIH) and Food and Drug Administration (FDA), which recommend DSMBs for large, multi-site, or high-risk trials to periodically review accumulating data, assess safety and efficacy, and advise sponsors on trial continuation, modification, or termination. These standards emphasize independence, predefined charters, expertise (e.g., clinicians, biostatisticians), conflict-of-interest management, and confidentiality to uphold ethical and scientific rigour.
Keywords: Data Safety Monitoring Board; DSMB; clinical trials; India; global standards; ICH-GCP; participant safety; data integrity; regulatory frameworks.
Cite This Article:
Please cite this article in press G Nithya et al., Comparative Study Of Data Safety Monitoring Board (Dsmb) Practices In Indian Clinical Trials Versus Global Standards.,. Indo Am. J. P. Sci, 2026; 13(09).
REFERENCES:
1. National Institute on Drug Abuse (NIDA) – Guidelines for Establishing and Operating a Data and Safety Monitoring Board (DSMB), highlighting safety oversight expectations and DSMB responsibilities in clinical trials. NIDA
2. National Institute on Alcohol Abuse and Alcoholism (NIAAA) – DSMB roles, composition, and functions in NIH-supported trials. NIAAA
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