Titlebook: Data Monitoring Committees (DMCs); Past, Present, and F Nand Kishore Rawat,David Kerr Book 2023 The Editor(s) (if applicable) and The Autho

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https://doi.org/10.1007/978-3-031-79281-6ings. This includes DMC kick-off meeting, data review meeting (as well as interim analysis meetings), top-line meetings, and ad hoc meetings. The sessions within a meeting are covered: standard open and closed sessions, recap sessions, and executive sessions. Considerations for meeting format, length, and frequency are provided.

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https://doi.org/10.1007/978-3-031-79986-0fety and efficacy. These include outputs to evaluate study integrity, baseline data, disposition, and treatment exposure. Additional review that the DMC or SDAC might conduct includes event projections and randomization audits.

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Communication Problems in Autismt reflects the integrity of the study, or in safety or efficacy domains. The concept of equipoise is introduced. The DMC has many options to help them in the case of difficult choices – either requesting more information and/or making non-trivial recommendations but not the ultimate level of recommending the stop of the study.

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Communication Problems in Autismut are reflective of the hundreds of DMC experiences seen. Example are from a wide range of clinical areas, and therefore wide range of endpoints and clinical context. The DMC focus on some examples is primarily safety-based, whereas others are primarily efficacy-based.

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https://doi.org/10.1007/978-3-031-28760-2Clinical Trials drug approval; Clinical trials vaccine approval; FDA drug approval; unbiased review of

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https://doi.org/10.1007/978-3-031-79986-0This chapter mentions materials that might be sent to the DMC outside of the normal DMC meetings. These primarily are deaths, SUSARs, and/or SAEs. The pros and cons of these are weighed and what the process could be to help the DMC keep informed between DMC meetings without burdening them.