Inclusivity and inequalities: the future of clinical trials
The session will address how clinical trials for new medicines and diagnostics, when well designed and delivered, can be inclusive and even start to help address health inequalities.
Health inequalities have persisted and even widened in recent years, despite this being an era of medical innovation. However, we can only advance science and improve outcomes for everyone if they’re represented in clinical trials and testing.
But ensuring clinical trial protocols and participant recruitment strategies are designed with inequalities in mind is challenging. Similarly AI-enabled diagnostics and digital therapeutics must ensure representativeness and avoid exclusion in the training and validation data sets used.
In 2020, with our partners, Moderna enrolled more than 31,000 participants in COVID-19 vaccine trials, and our Phase 3 COVE study was conducted in more than 100 locations across the US. With COVE, our goal was to design a trial for everyone and we slowed to ensure representation.
In the end, our trial included more than 11,000 participants from communities of colour, representing 37 per cent of the study population: similar to the diversity of the US at large and representative of the US population at risk for COVID-19 infection. Moderna is keen to apply the learning from this COVID-19 trial experience to future studies.
This session will discuss how a focus on being inclusive and reducing inequalities can be instilled in clinical trial design and delivery, for both new medicines and new digital health tools, recognising the challenges but also highlighting where there may be untapped opportunities.
This session is sponsored by Moderna.