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Benchmarking the Study Initiation Process.

Mary Jo Lamberti1, Cindy Brothers2, Dan Manak3

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

Therapeutic Innovation & Regulatory Science
|September 20, 2018
PubMed
Summary
This summary is machine-generated.

Reducing clinical trial delays requires optimizing the study start-up phase. Early site initiation processes significantly impact overall cycle time, with variations observed across therapeutic areas, site types, and regions.

Keywords:
cycle timesite initiationstudy start-up

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Area of Science:

  • Clinical trial management
  • Drug development efficiency
  • Pharmaceutical research operations

Background:

  • The study start-up phase is critical for pharmaceutical and biotechnology companies aiming to enhance clinical trial efficiency.
  • Delays in study start-up can significantly impact the overall timeline and cost of drug development.
  • Understanding key metrics within this phase is essential for process improvement.

Purpose of the Study:

  • To examine and analyze metrics within the clinical trial study start-up phase.
  • To identify key areas contributing to delays and inefficiencies.
  • To understand variations in cycle time to the first patient.

Main Methods:

  • Analysis of comprehensive metrics from 105 global clinical trials.
  • Collaboration with 11 pharmaceutical and biotechnology companies.
  • Examination of study data focusing on the study start-up phase and cycle time to first patient.

Main Results:

  • The early stages of the site initiation process account for the majority of the clinical trial cycle time.
  • Variations in cycle time to the first patient were observed across different therapeutic areas.
  • Site type and region significantly influence the time to the first patient, with academic and government sites being slower than physician practices.

Conclusions:

  • Optimizing early site initiation processes is crucial for reducing overall clinical trial timelines.
  • Addressing variations in cycle time based on site type and region can improve study start-up efficiency.
  • Further investigation into factors driving these variations is warranted to streamline drug development.