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The valley of death: why Australia failed to develop clinically effective drugs in COVID-19
1Clinical Pharmacology and Drug Repurposing and Medicines Research Program, University of Newcastle, Newcastle, New South Wales, Australia.
Abstract:
There is a paucity of public discussion of costs spent on drug trials during coronavirus disease 2019 (COVID-19) and their value, and of large public outlay on research funding for vaccine and drug development that did not deliver medicines nor vaccines for Australians. This oversight left us at the behest of global supply chains, politics and commercial cost-plus pricing for vaccines. It is possible that these outcomes were the result of some major cognitive biases and the failure of a clinical pharmacologist's voice in the leadership teams. Biases included unawareness of the complexities of taking interesting chemicals in vitro to development into therapeutic use that can be tolerated, show efficacy and have appropriate disposition in humans; lack of a systems approach to therapeutic development; and an understanding of the relevance and translatability of pharmacology, physiology and clinical drug development. We believe that reflecting on and addressing these biases will help Australia reposition itself better with a therapeutics and clinical trial strategy for future pandemics, built into the strategy of a Centre for Disease Control.
Insights
Public spending on COVID-19 drug trials and vaccine development lacked transparency and value assessment. Addressing cognitive biases and integrating clinical pharmacology expertise can improve Australia
Area of Science:
- Pharmacology and Clinical Therapeutics
- Public Health Policy
- Pandemic Preparedness
Background:
- Limited public discourse on the cost-effectiveness of drug trials during the COVID-19 pandemic.
- Significant public investment in vaccine and drug research yielded no deliverable medicines or vaccines for Australia.
- Australia's reliance on global supply chains and commercial pricing due to insufficient domestic therapeutic development.
Purpose of the Study:
- To analyze the value and public cost of drug trials during the COVID-19 pandemic.
- To identify cognitive biases and systemic failures in Australia's therapeutic development strategy.
- To propose improvements for a national therapeutics and clinical trial strategy for future pandemics.
Main Methods:
- Review of public spending on drug trials and vaccine development during the COVID-19 pandemic.
- Analysis of cognitive biases potentially influencing therapeutic development decisions.
- Assessment of the role of clinical pharmacology expertise in leadership and strategy.
Main Results:
- A lack of transparency regarding the costs and value of COVID-19 drug trials.
- Identification of cognitive biases, including underestimation of development complexities and a lack of systems thinking.
- The absence of clinical pharmacology and translational science expertise in key decision-making teams.
Conclusions:
- Addressing cognitive biases and integrating clinical pharmacology are crucial for effective therapeutic development.
- Australia needs a robust national strategy for therapeutics and clinical trials, integrated with a Centre for Disease Control.
- Improved strategies are essential to enhance national preparedness and reduce reliance on external factors for future pandemics.
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