Janssen&Janssen schreef op 19 augustus 2021 23:41:
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10. Data Monitoring Committee, Steering Committee and
Interim Analyses
The Steering Committee (SC) and the Data Monitoring Committee (DMC) will be
responsible for safeguarding the interests of clinical trial participants and for
enhancing the integrity of the trial. To address this mission, the DMC will have
ongoing access to efficacy and safety data, and information regarding the quality of study conduct. The DMC will review emerging evidence provided by
the independent statistical center on a periodic basis (e.g. every two to three
months, or as appropriate for outbreak circumstances and enrolment) and at
appropriate times, where the interpretation of safety will be performed in the
context of this emerging efficacy data. The DMC will also have planned formal
interim analysis meetings. In addition, the DMC will hold ad hoc teleconference
meetings to discuss safety or trial conduct information as needed, with input
provided by the SC during open sessions of DMC meetings.
A Steering Committee (SC) will be in place to collaborate with the study
Sponsor(s) in issues regarding trial design, conduct and analysis. The SC will ensure
the conduct of the trial in each site is harmonized with respect to the important
variables such as data collected, laboratory tests, implementation of treatments
and standard of care. There will ideally be a centralized database for all the trial
sites to contribute data.
The trial will be designed with pre-specified formal statistical monitoring
boundaries to guide the DMC in their recommendations regarding continuation
or termination of regimens or of the entire trial, either due to persuasive evidence
of efficacy or futility, or unacceptable safety issues.
In assessing the acceptability of the safety profile of each regimen, the DMC will
consider the totality of information regarding benefits and risks. To contribute to
enhancing the integrity of the trial, the DMC may also formulate
recommendations relating to the rates of recruitment and eligibility of
participants, improving adherence to protocol-specified regimens, retention of
participants, and the timeliness of data capture and adjudication of trial
endpoints.
Based on its insights from emerging evidence, the DMC will provide
recommendations to the SC, including a recommendation regarding trial
continuation, discontinuation or modification. The DMC will be advisory to the SC,
who will be responsible for promptly reviewing the DMC recommendations,
discussing them with the DMC if necessary, the study sponsor, and making
decisions about their implementation.
A separate DMC Charter further describes the role of the DMC and the SC. The
Statistical Analysis Plan will provide the complete specification of the statistical
methods for the interim analyses.