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Developing a guideline for clinical trial protocol content: Delphi consensus survey

Jennifer Marie Tetzlaff1, David Moher, An-Wen Chan

  • 1Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada. jtetzlaff@ohri.ca

Trials
|September 26, 2012
PubMed
Abstract

Insights

Experts reached consensus on essential content for randomized clinical trial (RCT) protocols using a Delphi survey. This work guides the development of standardized RCT protocol guidelines.

Area of Science:

  • Clinical Trials
  • Research Methodology
  • Health Sciences

Background:

  • Clinical trial protocols often exhibit deficiencies impacting various stakeholders.
  • Existing guidelines for randomized clinical trial (RCT) protocol content lack standardization and systematic development methods.
  • This study is a key step in developing a comprehensive guideline for RCT protocol content.

Purpose of the Study:

  • To develop and refine minimum content requirements for randomized clinical trial (RCT) protocols.
  • To establish a consensus on essential items for RCT protocols through a systematic process.
  • To inform the creation of a standardized guideline for clinical trial protocol development.

Main Methods:

  • A three-round Delphi consensus survey was employed.
  • Expert panellists (n=96) from diverse stakeholder groups were recruited iteratively.
  • Panellists rated the importance of protocol content items, with consensus levels analyzed.

Main Results:

  • Sixty-three of 88 concepts were rated as highly important for minimum RCT protocol content.
  • Fifty concepts achieved a high importance rating (25th percentile ≥ 8).
  • Moderate and low importance items were also identified, providing nuanced insights.

Conclusions:

  • A diverse panel of experts achieved consensus on essential RCT protocol content.
  • The Delphi process identified areas of agreement and divergence in protocol requirements.
  • Findings will contribute to developing a robust guideline for clinical trial protocol content.

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