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Drivers of Start-Up Delays in Global Randomized Clinical Trials

Jennifer Lai1, Leila Forney2, Daniel L Brinton2

  • 1Medical University of South Carolina, Charleston, SC, USA. Jennifer.spallone@gmail.com.

Therapeutic Innovation & Regulatory Science
|September 22, 2020
PubMed
Abstract

Insights

Global clinical trial start-up delays are common and impact timelines. A checklist derived from analyzing literature can help clinical trial managers mitigate these delays, improving efficiency and speeding patient access to new therapies.

Area of Science:

  • Clinical Trials
  • Pharmaceutical Research
  • Regulatory Science

Background:

  • Global, randomized clinical trials are complex, with start-up being a critical phase prone to delays.
  • These delays negatively affect study timelines and budgets, hindering the swift delivery of potential new therapies to patients.

Purpose of the Study:

  • To identify key factors contributing to start-up delays in global, Phase III clinical trials.
  • To develop a practical tool to aid clinical trial managers in streamlining the trial initiation process.

Main Methods:

  • A comprehensive literature review on the start-up of global, Phase III clinical trials.
  • Development of a fishbone diagram to categorize and visualize identified drivers of delay.
  • Creation of a checklist based on the identified issues to assist trial managers.

Main Results:

  • Key drivers of start-up delays were categorized into regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and process inefficiencies.
  • The identified issues highlight multifaceted challenges in initiating complex clinical studies.

Conclusions:

  • Initiating global randomized clinical trials is inherently complex, with numerous documented causes for delay.
  • A structured checklist can empower clinical trial managers to proactively address potential delays, facilitating earlier study initiation and faster patient access to novel treatments.
Keywords:
Best practicesGlobal clinical trialsPerformanceProcess optimizationStudy start-upTrial efficiency

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