RESEARCH TIPS
This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research.
This Month’s Subject—National Institutes of Health Policy on Oversight and Monitoring of Clinical Trials
Did you know?
It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials. The establishment of the data safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).
Principles of Monitoring Data and Safety
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All clinical trials require monitoring
Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.
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Monitoring should be commensurate with risks
The method and degree of monitoring needed is related to the degree of risk involved. A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully. Risk associated with participation in research must be minimized to the extent practical.
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Monitoring should be commensurate with size and complexity
Monitoring may be conducted in various ways or by various individuals or groups, depending on the size and scope of the research effort. These exist on a continuum from monitoring by the principal investigator or NIH program staff in a small phase I study to the establishment of an independent data and safety monitoring board for a large phase III clinical trial.
For full text please see:
http://grants.nih.gov/grants/guide/notice-files/not98-084.htm |
