Such trials usually involve a large number of participants followed for longer periods of treatment exposure to monitor adverse events and to collect information that will allow the treatments to be used safely.
The organization, responsibilities, and operation of the DSMC are described below. Voting members should include clinicians, statisticians, other scientists, and public representatives. These individuals should be selected for their experience, knowledge of clinical trial methodology, and absence of conflicts of interest. Voting members of the DSMC should be independent of the trial s to be monitored. In exceptional circumstances, a voting member may be from an institution participating in the trial.
In this situation, the member should view his or her role as representing the interests of the patients enrolled in the trial and not those of the institution. A written report containing at least the current status of the trial, performance and data quality, interim outcome data, and any toxicity data should be sent to DSMC members by the Coordinating Center to allow sufficient time for the DSMC members to review the report prior to the meeting. This report should address any specific concerns about the conduct of the trial.
The frequency of DSMC meetings will depend on the nature of the trial. However, a DSMC should meet at least annually. The focus in the open session may be on accrual, protocol compliance, and general toxicity issues. Outcome results by treatment group should not be discussed during this session. A second, closed session involving the voting members, NEI study program directors and select representatives from the data coordinating center should be held.
The outcome results and toxicity information, if any, will be presented to the DSMC by treatment group. A third, executive session involving voting DSMC members and the NEI program director as an objective observer should be held to allow for the opportunity to discuss the general conduct of the trial and all outcome results, including toxicities and adverse events.
During the executive session, voting DSMC members will independently develop recommendations and vote as necessary. As a steward of public funds for clinical research, the NEI program director is responsible for programmatic and administrative oversight of the clinical trial and oversight of clinical research monitoring activities which is distinct from the monitoring itself.
At the initial DSMC meeting, the Board should establish guidelines for conducting unmasked data reviews by some or all of its members. The DSMC can modify these guidelines as it deems necessary during the conduct of the trial. DSMC recommendations should be based on results from the trials being monitored as well as on published data from other studies. It is the responsibility of the Coordinating Center, study Chair, trial investigators, NEI staff, and individual DSMC members to ensure that the DSMC is kept apprised of non-confidential outcome results from other related studies as they become available.
If the DSMC recommends a change for patient safety or efficacy reasons, or recommends that the study be closed early for slow accrual or other reasons, the study Chair and Coordinating Center, in collaboration with the NEI, must act to implement the change as expeditiously as possible.
Confidentiality must be maintained during these discussions. If a recommendation is made to change a protocol for other than patient safety or efficacy reasons or for slow accrual, the DSMC will provide an adequate rationale for its decision. In the absence of disagreement, the Coordinating Center will be responsible for amending the protocol and notifying the clinical centers as expeditiously as possible.
It will be the responsibility of the local clinical center directors to notify their local IRBs of any protocol changes. Confidential outcome data should not be made available to individuals outside of the DSMC. No communication, either written or oral, of the deliberations or recommendations of the DSMC will be made outside of the DSMC except as provided for in these guidelines.
Outcome results are strictly confidential and must not be divulged to any non-member of the DSMC. Each member of the DSMC, including non-voting members, must sign a statement of confidentiality. Individuals invited to serve on the DSMC will disclose any potential conflicts of interest, whether real or perceived, to the Director of the Coordinating Center on an annual basis.
Conflict of interest can include financial interest, professional interest in the sense of the trial outcome benefiting the individual professionally , proprietary interest, and miscellaneous interest as described in the NIH Grants Policy and 45 CFR Part Decisions regarding service by individuals with potential conflicts of interest or the appearance of conflicts of interest will be made collaboratively by NEI and the study leadership.
Specific questions about this Notice should be directed to any member of the NEI Collaborative Clinical Research group at Maryann Redford, D. Sangeeta Bhargava, Ph. Search the site. Policy The National Eye Institute NEI has established the following guidelines 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 from all NEI-supported or -conducted clinical trials.
Introduction A detailed data and safety monitoring plan for all clinical trials must be submitted as part of the application. Responsibility for data and safety monitoring The following material provides illustrative examples of appropriate types of monitoring and oversight for different types of studies. While the DMC plays an important role in maintaining the validity and integrity of the intended clinical trial, adaptive design clinical trials trigger a greater role and increased responsibility for the DMC.
To assist the sponsor in establishing a DMC, the U. Concerns of the additional responsibilities of the DMC for adaptive design clinical trials are addressed. Although the intention of the DMC is well-intentioned, controversial issues inevitably occur.
These controversial issues include, but are not limited to, 1 the challenge of the independence of a DMC and 2 the issue regarding the direct communication between the DMC and the FDA.
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