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Moving forward in clinical research with master protocols

Jay J H Park1, Louis Dron2, Edward J Mills2

  • 1Experimental Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

Contemporary Clinical Trials
|May 17, 2021
PubMed

Insights

Billions invested in COVID-19 research yielded poor returns for therapeutics, highlighting clinical trial inefficiencies. Structural changes are crucial for future pandemic preparedness and effective therapeutic development.

Area of Science:

  • Medical Research
  • Clinical Trials
  • Epidemiology

Background:

  • The COVID-19 pandemic spurred unprecedented research and development (R&D) investment.
  • Significant R&D funding has been directed towards novel coronavirus disease 2019 (COVID-19) therapeutics.
  • The scientific community's response has faced challenges in delivering effective therapeutic solutions.

Purpose of the Study:

  • To analyze the return on investment (ROI) of COVID-19 therapeutic research.
  • To identify weaknesses and inefficiencies within the existing clinical trial enterprise.
  • To advocate for structural reforms in clinical trial research programs.

Main Methods:

  • Review of R&D funding allocation for COVID-19 therapeutics.
  • Analysis of clinical trial outcomes and success rates for COVID-19 treatments.
  • Comparative assessment of the clinical trial enterprise's response to the pandemic.

Main Results:

  • Despite substantial investment, therapeutic research for COVID-19 has shown a poor ROI.
  • The COVID-19 pandemic exposed significant structural weaknesses in clinical trial operations.
  • Existing research programs demonstrated inefficiencies in adapting to urgent global health needs.

Conclusions:

  • The current clinical trial system requires fundamental structural changes to improve efficiency and ROI.
  • Lessons learned from the COVID-19 pandemic necessitate reforms in research programs for future public health crises.
  • Implementing structural changes is vital for optimizing therapeutic development and pandemic response.

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