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PHESI GLOBAL ANALYSIS:
IMPACT OF CLINICAL TRIAL
COMPLEXITY ON ROI

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Despite innovation in clinical trials over the past decade, lengthy trial timelines and increasing trial costs continue to plague the biopharmaceutical industry. Success rates remain low. This paper examines the impact of trial complexity by modelling the number of outcome measures in a protocol, and shows that the overcollection of data adds months to clinical trials, increases patient burden, and reduces return on investment.

Using our AI-driven Trial Accelerator™ platform to analyze 2,401 industry-sponsored Phase III clinical trials, our global analysis of the top five disease indications shows:

  • A significant number of phase III clinical trials are over-collecting data because of overcomplicated protocol designs

  • The more outcome measures included in a trial protocol, the lower the percentage of those outcomes reported in results

  • A correlation between a lower number of outcome measures and better site enrollment due to reduced burden to patients and investigator sites
Impact of Clinical Trial Complexity - report

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