Ethical and informative trials: How the COVID-19 experience can help to improve clinical trial design

Abstract

During the COVID-19 pandemic, the race to find an effective vaccine or treatment saw an ‘extraordinary number’ of clinical trials being conducted. While there were some key success stories, not all trials produced results that informed patient care. There was a significant amount of waste in clinical research during the pandemic which is said to have hampered an evidence-based response. Conducting trials which could have been predicted to fail to answer the research question (e.g. because they are not large enough to provide a definitive result) is not only a waste of resources but also a breach of research participants’ trust and a violation of research ethics. The issues seen in COVID-19 clinical trials are symptomatic of a wider trial design crisis where many trials do not provide informative results. This paper examines the roles of key stakeholders in delivering ethical and informative trials and whether guidance published by ‘The Good Clinical Trials Collaborative’ could be used to align key stakeholder groups and enable a joined-up approach to improve clinical trial design.