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THE PHARMA REVIEW (DECEMBER, 2007 - JANUARY, 2008)

Data Safety Monitoring Board

R.K. Rishi

Abstract: The ethical consideration in clinical trials involving human subjects is that the study should not be continued if there is strong evidence that the results are negative or the design of study is inappropriate. To ensure the safety of participants and the validity of the data in clinical trials, current drug regulatory scenario ensures that a system be in place for appropriate oversight and monitoring of trials. Investigators are required to submit a description of a data safety monitoring plan (DSMP) for all clinical trials as part of their proposal, which must include a general description of the Data Safety Monitoring Board (DSMB) and mechanisms for reporting adverse events to the Institutional Review Board(s) and to the Regulatory Authority.

The extent of monitoring of a clinical trial should be according to the nature, size, and complexity of the trial. The data and safety monitoring plan may vary from a safety officer to a committee known as a DSMB. This ongoing review of the data by an independent individual or DSMB assures the integrity of the clinical trial and or to protect the dignity, rights, safety, and well-being of research participants. These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The recommendations of DSMB are mainly focused on safety of study participants.

It is well known that in the process of drug discovery, conducting clinical trial is very costly and time consuming affair. Whether to continue a particular trial, the sponsor and investigator may need independent and unbiased advice for making such decisions. If early detection of risks of a potential molecule is made, it saves huge amount of money. It is now recognized that DSMB can provide independent assessment of the appropriateness of the trial to ensure scientific integrity of the study, protection of human subjects, credibility of data, and avoidance of conflict of interest, so that highest possible scientific and ethical standards are adhered to and maintained in the study.

DSMBs are playing crucial role in the process of ensuring the highest standards for research participants, medical safety and data quality of clinical trials. Clinical investigators, IRBs, drug regulators, industry, and sponsors are all influenced by the emerging role of DSMBs. The role of DSMBs has increased due to the increased number of trials with mortality or severe morbidity as endpoints, the greater need to monitor the quality of the clinical trials data, and the demand for early termination of trials for safety or efficacy reasons.

 

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