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Feb 12, 2024 · We discuss drivers of increasing trial complexity, necessary or helpful (‘good’) complexity versus unnecessary (‘bad’) complexity, and we explore mechanisms of how sponsors of clinical ...
- Trends in clinical trial design complexity | Nature Reviews ...
These study findings are striking given research linking...
- Trends in clinical trial design complexity | Nature Reviews ...
May 14, 2019 · How can the complexity of a clinical trial be assessed in a consistent manner across varying disease types? Research leaders struggle with these questions and how to adequately staff their research units to prevent burnout or decreased quality of services.
The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures, and data collection. Protocols, case report forms, and other operational documents should be clear, concise, and consistent.
Apr 18, 2017 · These study findings are striking given research linking protocol complexity to longer cycle times, higher numbers of protocol amendments and lower patient recruitment and retention rates (for...
- Kenneth A. Getz, Rafael A. Campo
- 2017
Nov 13, 2020 · The median time from full IRB approval to study activation (participants may be consented) was 55 days (range, 1-270 days). The median time from receipt of draft contract to execution was 94 days (range, 14-283 days). The median time from SRC/PRC approval to first patient accrued was 167 days (range, 14-327 days).
- Carrie Lee, Theresa L Werner, Allison M Deal, Cassandra J Krise-Confair, Tricia Adrales Bentz, There...
- 2021
Aug 3, 2022 · Complexity in clinical trials occurs in nearly every therapeutic area, for nearly every sponsor, and in many of today’s trials. Protocol complexity covers intricacies in the study design and can be related to the treatment, patient flow through the study, and point-in-time complexities.
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Feb 18, 2020 · To evaluate patient follow-up and complexity in cancer clinical trial delivery, using consensus methods to: (1) identify research professionals’ priorities, (2) understand localised challenges, (3) define study complexity and workloads supporting the development of a trial rating and complexity assessment tool (TRACAT).
