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The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of Real World Evidence generation

Mira G P Zuidgeest1, Iris Goetz2, Anna-Katharina Meinecke3

  • 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

Journal of Clinical Epidemiology
|December 20, 2021
PubMed

Insights

Pragmatic clinical trials integrate real-world elements to assess treatment effectiveness in routine care. The GetReal Trial Tool aids researchers in optimizing pragmatic trial design for better evidence translation.

Area of Science:

  • Clinical Trial Design
  • Health Services Research
  • Evidence-Based Medicine

Background:

  • Pragmatic clinical trials offer a way to evaluate treatments in real-world settings.
  • Challenges such as result acceptability and operational feasibility hinder their widespread adoption.

Purpose of the Study:

  • To introduce the GetReal Trial Tool, an online interface designed to assist researchers.
  • To help optimize pragmatic trial design by assessing key factors like generalizability and feasibility.

Main Methods:

  • Development of the GetReal Trial Tool based on scientific literature and expert consensus.
  • The tool evaluates design choices against criteria including risk of bias, precision, acceptability, and feasibility.

Main Results:

  • The GetReal Trial Tool provides an accessible method for assessing the impact of design decisions.
  • It facilitates the optimization of pragmatic trial designs for improved real-world applicability.

Conclusions:

  • The GetReal Trial Tool supports researchers in designing pragmatic trials that yield generalizable and actionable evidence.
  • It aims to bridge the gap between trial results and routine clinical practice.
Keywords:
Clinical trialEpidemiologyMedical ethicsPragmatic trialReal world evidenceResearch design

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