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Neither good nor bad
- In and of itself, trial complexity—as defined by our score—is neither good nor bad. There are often legitimate reasons for higher complexity trials, such as the need to address specific unmet medical needs, to ensure rigorous trial design, to address regulatory requirements, or the desire to explore novel scientific objectives.
www.ncbi.nlm.nih.gov/pmc/articles/PMC10861486/Clinical trials are becoming more complex: a machine learning ...
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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...
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 ...
Apr 18, 2017 · The challenges of measuring the safety and efficacy of investigational drugs that target chronic, difficult-to-treat or rare diseases in more narrowly defined patient subpopulations have increased...
- Kenneth A. Getz, Rafael A. Campo
- 2017
Jan 17, 2022 · Protocol complexity is continuing to climb, adding unplanned time and cost to clinical trials, according to a new report that found the number of deviations and substantial amendments has increased almost four percentage points in the past decade.
Clinical studies are becoming larger, longer, and more complex, intensifying competition for study centers and individual participants. Leveraging digital tools, decentralized trials, and personalized engagement strategies can enhance patient recruitment and retention.
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Aug 3, 2022 · It’s easy to feel like clinical trials are complex. They are experiments involving human beings — so things change. But, despite feeling like complexity is everywhere, there is little clarity on what constitutes a complex trial and what sponsors need to do to prepare these trials for success.
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.
