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1. www.nature.com › articles › s41598/024/53211-zClinical trials are becoming more complex: a machine learning ...

   www.nature.com › articles › s41598/024/53211-z

   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 ...

2. www.ncbi.nlm.nih.gov › pmc › articlesClinical trials are becoming more complex: a machine learning ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Feb 12, 2024 · This has led many observers to question whether clinical trials have become overly complex. Here we report a large-scale analysis of protocols and other publicly available data from clinical trials over the past 10 years, corresponding to more than 16,000 studies.

   • DOI: 10.1038/s41598-024-53211-z
   • Published: 2024

   • Publication: Sci Rep. 2024; 14: 3514.

3. www.nature.com › articles › d41586/024/00753-xHow AI is being used to accelerate clinical trials - Nature

   www.nature.com › articles › d41586/024/00753-x

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   Mar 13, 2024 · Half of that time and money is spent on clinical trials, which are growing larger and more complex. And only one in seven drugs that enters phase I trials is eventually approved.

4. acrpnet.org › 2021/05/05 › clinical-trial-complexityClinical Trial Complexity Levels Show Unrelenting Increase

   acrpnet.org › 2021/05/05 › clinical-trial-complexity

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   May 5, 2021 · Clinical trial durations for oncology drugs are 30% to 40% longer than for other drug trials, due to more complex designs and difficulty finding, enrolling, and retaining study volunteers.

5. www.centerwatch.com › articles › 25921-no-end-inNo End in Sight for Trial Complexity, CSDD Report Reveals

   www.centerwatch.com › articles › 25921-no-end-in

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   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.

6. www.suvoda.com › insights › blogHow To Identify & Create Successful Complex Clinical Trials

   www.suvoda.com › insights › blog

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   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.

7. People also ask

   Are clinical trials too complex?

   • Also there have been regulatory changes, increasing competitive pressures and other external factors which impact clinical trials. In parallel, trial timelines have increased and success rates remain stubbornly low. This has led many observers to question whether clinical trials have become overly complex and if this complexity is always needed.

   Clinical trials are becoming more complex: a machine learning analysis

   www.nature.com/articles/s41598-024-53211-z

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   Is clinical trial complexity increasing?

   • This suggests that clinical trial complexity, as measured by the score, is indeed increasing (Fig. 2). Over the last 10 years the average complexity score across all trials has increased by more than 10 percentage points, from the low-30s to the mid-40s.

   Clinical trials are becoming more complex: a machine learning analysis

   www.nature.com/articles/s41598-024-53211-z

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   Is trial complexity good or 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.

   Clinical trials are becoming more complex: a machine learning analysis

   www.nature.com/articles/s41598-024-53211-z

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   How often should trial complexity be assessed?

   • Throughout the trial design process, complexity should be assessed regularly to ensure the trial complexity remains under control. In governance forums, trial complexity can be a useful dimension to support decision making about planned trials.

   Clinical trials are becoming more complex: a machine learning analysis

   www.nature.com/articles/s41598-024-53211-z

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   What is a complexity score in clinical trials?

   • The weights were derived using regression, such that the score correlates with overall trial duration—which is of great interest to many sponsors of clinical trials and other practitioners. Complexity scores range from 0 to 100%, with lower scores corresponding to less complex trials.

   Clinical trials are becoming more complex: a machine learning analysis

   www.nature.com/articles/s41598-024-53211-z

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   Are clinical trials a good idea in the UK?

   • There is considerable enthusiasm for clinical trials among health professionals and the public in the UK. There have been some recent successes, such as the recruitment of 140 000 participants in just 10 months to the NHS-Galleri trial of early cancer detection.

   Accelerating clinical trials: time to turn words into action

   www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01181-9/fulltext

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8. www.thelancet.com › journals › lancetAccelerating clinical trials: time to turn words into action

   www.thelancet.com › journals › lancet

   Jul 15, 2023 · Randomised clinical trials provide a sound method to understand whether, how well, and for whom health interventions are effective. The evidence such trials generate informs regulatory licensing, health-care policy, and individual clinical care. The COVID-19 pandemic highlighted the challenge.