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Published on: January 16, 2019

The clinical research enterprise in critical care: what's right, what's wrong, and what's ahead?

Michael C Reade1, Derek C Angus

  • 1Department of Intensive Care Medicine (MCR), Austin Hospital, University of Melbourne, Melbourne, VIC, Australia.

Critical Care Medicine
|December 24, 2008
PubMed

Insights

Critical care physicians excel at evaluating current treatments using randomized controlled trials. However, translating new pharmacotherapy into practice faces challenges due to flawed early studies and implementation gaps.

Area of Science:

  • Critical care medicine
  • Pharmacotherapy research
  • Translational science

Background:

  • Intensivists effectively use randomized controlled trials (RCTs) for assessing current practices.
  • Trials of novel pharmacotherapy in critical care have faced significant challenges.
  • This contrasts with the success seen in evaluating established treatments.

Purpose of the Study:

  • To analyze the reasons behind the failure of new pharmacotherapy in critical care.
  • To identify barriers in translating basic science discoveries into clinical practice.
  • To propose a path forward for improving the development and implementation of novel treatments.

Main Methods:

  • Review of existing literature on pharmacotherapy trials in intensive care.
  • Analysis of common pitfalls in early-phase clinical studies.
  • Examination of implementation science principles relevant to critical care.

Main Results:

  • Many new treatments fail in Phase III trials despite sound methodology, often due to flawed early studies or misunderstandings of biological processes.
  • New approaches are inconsistently adopted, either implemented prematurely based on weak evidence or ignored despite strong support.
  • A gap exists between understanding disease mechanisms and successful clinical application.

Conclusions:

  • Critical care medicine needs to improve the translation of basic science into effective clinical treatments.
  • Addressing flaws in early-phase studies and improving implementation strategies are crucial.
  • A more robust approach is needed to bridge the gap between pathophysiological rationale and successful pharmacotherapy in the ICU.

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