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New Benchmarks Characterizing Growth in Protocol Design Complexity.

Kenneth A Getz1, Rafael A Campo2

  • 11 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Tufts University, Boston, MA, USA.

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Summary
This summary is machine-generated.

Clinical trial protocol complexity is rapidly increasing, with significant growth in procedures, site workload, and costs from 2001-2015. Phase I trials remain most complex, while Phase III shows the largest increase in complexity.

Keywords:
clinical research protocolsclinical study designclinical trial costclinical trial cycle timeclinical trial designprotocol complexityprotocol design

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Area of Science:

  • Clinical Research
  • Drug Development
  • Biostatistics

Background:

  • The complexity of clinical trial protocols significantly impacts study execution and resource allocation.
  • Understanding trends in protocol complexity is crucial for efficient drug development.

Purpose of the Study:

  • To analyze trends in clinical trial protocol complexity over a decade.
  • To establish updated benchmarks for protocol complexity measures.

Main Methods:

  • Analysis of 9,737 clinical trial protocols and 130,601 investigative site contracts.
  • Comparison of complexity measures between 2001-2005 and 2011-2015 cohorts.

Main Results:

  • Protocol complexity measures (procedures per patient, site effort, visits) significantly increased across Phase I, II, and III trials (P < .0001).
  • Costs per patient visit and overall costs per patient also rose significantly.
  • Phase I protocols remain the most complex; Phase III protocols exhibit the most substantial growth in complexity.
  • Phase IV protocols showed only modest increases in complexity.

Conclusions:

  • Clinical trial protocol complexity is escalating, particularly in Phase III studies.
  • Increased complexity necessitates adaptive strategies for efficient clinical trial execution and resource management.
  • These findings provide critical benchmarks for optimizing future clinical trial designs.