Learnings about clinical trial design from COVID-19
Protas colleagues have published a new article exploring what COVID-19 taught us about improving clinical trial design.
During the COVID-19 pandemic, the race to find an effective vaccine or treatment saw an “extraordinary number” of clinical trials being conducted.
Whilst there were some important success stories during the pandemic, such as the rapid development and deployment of COVID-19 vaccines and treatments, not all trials produced results that informed patient care.
This resulted in significant waste in clinical research, which is said to have hampered an evidence-based response.
A new article – “Ethical and informative trials: How the COVID-19 experience can help to improve clinical trial design” – underscores the importance of well-designed trials to reduce research waste and ensure ethical participation in research.
Authors Emma Law (Head of Clinical Quality Assurance) and Isabel Smith (Senior Research Officer) analyse the lessons learned from the COVID-19 pandemic and the wider clinical trials landscape.
For instance, an analysis of clinical trials for COVID-19 worldwide performed by United States Food and Drug Administration (FDA) scientists found that of 2,895 trial arms examined, merely 5% could be considered randomised and adequately powered, with only about a quarter of enrolled patients contributing to adequately powered and well-controlled trials.
Poorly designed clinical trials present an ethical issue for participants – by taking part in research that fails to provide a definitive answer to the research question, participants may have been exposed to risks with no benefit to society or the care of future patients.
The road to smarter clinical trials
Emma and Isabel argue that gaps in governance systems could be contributing to research waste and inadvertently allowing uninformative trials to take place.
Adopting a joined-up approach with a shared framework for assessing a trial’s scientific validity and feasibility – namely, the Good Clinical Trials Collaborative’s Guidance – could help to promote both transparency and efficiency in clinical research, so that trials are:
- Producing a scientifically sound answer to a relevant question
- Respecting the rights and wellbeing of each participant
- Being collaborative and transparent
- Building and sustaining the trust of collaborators, participants and the wider public
- Designed to be feasible for their context
- Managing quality effectively and efficiently.
In addition, the authors emphasise the role of regulatory bodies, funding agencies and the scientific community in fostering these changes to create a more robust and ethical framework for future clinical trials.
“Our article highlights the importance of well-designed clinical trials for ethical participation in research,” says Emma.
“The lessons learned from the COVID-19 pandemic emphasise the importance of collaboration among stakeholders to ensure that clinical research is both informative and respectful of participants.
“We hope this work sparks meaningful dialogue in reducing research waste and focusing on the principals of well-designed trials to inform patient care.”
Emma and Isabel’s work is a timely reminder of the critical importance of ethical considerations in clinical research.
By drawing on the COVID-19 experience, they suggest a coordinated approach in improving the clinical trials landscape. This includes adoption of a shared framework with clear responsibilities for all stakeholders to facilitate well-designed, informative trials.
If you would like to speak with us about Protas’ work in trial design and delivery, we would love to hear from you.
“Ethical and informative trials: How the COVID-19 experience can help to improve clinical trial design” was first published in Research Ethics by Sage Journals.