The initial DSMB meeting should occur preferably before the start of the trial or as soon thereafter as possible. At this meeting the DSMB should discuss the protocol and the DSMB Charter which includes triggers set for data review or analyses, definition of a quorum, and guidelines for monitoring the study. Guidelines should also address stopping the study for safety concerns and, where relevant, for efficacy based on plans specified in the protocol.
At this meeting, the DSMB should also develop procedures for conducting business e. Once a study is implemented, the DSMB should convene as often as necessary, but at least once annually, to examine the accumulated safety and enrollment data, review study progress, and discuss other factors internal or external to the study that might impact continuation of the study as designed. Meetings may be held by conference calls or videoconferences or as face-to-face meetings. Open Session : Issues relating to the general conduct and progress of the study are discussed including adverse events and toxicity issues, accrual, demographic characteristics of enrollees in aggregate, disease status of enrollees if relevant , comparability of groups with respect to baseline factors, protocol compliance, site performance, quality control, and timeliness and completeness of follow-up.
Any data provided must be presented without grouping by treatment assignment or otherwise by preserving the masking of all subjects. Outcome results are not generally discussed during this session. The lead investigator and the study biostatistician should be in attendance in order to present results and respond to questions. This session is open to study investigators, coordinating center staff, representatives for industry collaborators, representatives from the Food and Drug Administration FDA , if applicable, and NIDCR program and regulatory staff.
Closed Session : Grouped safety data and, if appropriate, efficacy data are reviewed with the study statistician s available for consultation at this session. Grouped data should be presented by coded treatment arm. This session is normally attended only by voting members. This final session involves only DSMB voting members to ensure complete objectivity as they discuss outcome results, make decisions, and formulate recommendations regarding the study.
A brief summary that describes the individual findings, overall safety assessment and DSMB recommendations will be the responsibility of the Chair and forwarded to NIDCR within one week of the meeting. A quorum, as defined by the DSMB in the initial meeting, must be present either in person or by conference call. After a thorough discussion of DSMB members' opinions and rationale and an attempt to reach clarity regarding individual recommendations, the final recommendations of each DSMB member should be solicited during the Closed Session.
A consensus opinion or recommendation among members is not required; each member may have individual opinions. The final recommendations are recorded and either identified as majority or minority positions or are accompanied by actual vote tallies for each divergent recommendation, i. It is the responsibility of the PI to ensure that the DSMB is apprised of all new safety information relevant to the study product and the study.
When is a DSMB needed? DSMB submission process. Meeting Dates and Submission Deadlines. DSMB Resources. NIH program staff. Responsibility for Data and Safety Monitoring NIDCD-supported clinical trial monitoring activities should be commensurate with the risks, size, and complexity of the study. An independent medical monitor for participant safety and an independent data monitor for data integrity and protocol compliance.
Low-Risk Interventions The potential of these interventions to cause physical or psychological harm is low. For example: Risks that are no greater than those encountered in routine medical care or procedures. Some behavioral interventions that are not distressful, harmful, painful, or invasive to study participants. Software devices, including software applications unlikely to cause injury to the operator and study participants.
Some physical therapy interventions with a low level of exertion and discomfort. Exploratory Studies Exploratory studies, such as Phase I studies, are usually small, unblinded clinical trials conducted early in the development of an intervention.
Clinical Use Studies Clinical use studies, such as Phase III clinical trials, are large pivotal studies intended to provide formal statistical demonstration of efficacy and to monitor adverse events. Higher-Risk Interventions Exploratory Studies A typical exploratory clinical trial evaluating the safety of a new agent, device, or procedure such as a Phase I study involves relatively high risk to a small number of participants.
Confirmatory Studies A confirmatory clinical trial evaluating the clinical activity of exposure such as a Phase II trial typically follows early exploratory studies and provides more information regarding risks, benefits, and monitoring procedures. Responsibilities of the DSMB Review the research protocol s and plans for data and safety monitoring. The DSMB, in collaboration with the study leadership, should establish specific guidelines for safety monitoring. This should include a listing of events that should be reported immediately to the DSMB and the format of reporting cumulative data at intervals.
Review interim analyses of outcome data and cumulative toxicity data for safety and efficacy to determine whether the study should continue as originally designed, be changed, or be terminated. The DSMB reviews clinical study performance information such as participant recruitment and retention, clinical center and resource center performance, and proposals for ancillary studies. The DSMB also recommends whether and to whom outcome results should be released prior to the reporting of study results.
Review the primary study abstract s and manuscript s to determine if the results are fairly presented and the conclusions appropriate. Review major proposed modifications e. The recommendations should include the decision to continue, change, or terminate the study as well as justification for the decision.
Confidential data should not be included in the DSMB recommendation report. Tasks include but are not limited to the following: Handle all logistics related to each meeting or conference call, such as booking a group of rooms at a local hotel, providing information to the DSMB, and providing timely reimbursement to each member following each meeting.
Work with the DSMB to determine what information should be made available for review at each meeting to assist the DSMB in carrying out its primary charge related to participant protection oversight, study operation, and data integrity. Different information or tables may be required from meeting to meeting.
The study statistician must: Prepare and provide to the DSMB membership, at least 14 days prior to each meeting, the open and closed reports on the current status of the study, interim analyses, adverse events, and problems encountered. The open report should also be provided to the study chair, designated members of the study team, and NIDCD representative s at this time. Voting members of the DSMB should be independent of the trial being monitored. Meetings are generally divided into four parts: An open session at which members of the clinical study team, representatives from the NIDCD, and others may be present, at the request of the DSMB, to review the conduct of the study and to answer questions from DSMB members.
The focus in the open session should be on accrual, study conduct, and general toxicity issues. Experts discuss staying on top of adverse events More clinical trials are using data safety monitoring boards DSMBs in recent years as investigators, sponsors, and clinical trials managers increasingly see the value of added checks and balances to subject protection, experts say. Report Abusive Comment Thank you for helping us to improve our forums.
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