The inclusion of diverse patient populations in clinical trials is nothing new but the topic has risen to the surface in the last year and is now prevalent in high profile conferences and industry exchange.
Why are so many talking about it now? The answer probably lies at the intersection of three different incidents: the coronavirus pandemic which has pushed the industry in so many different ways, the FDA guidance issued in November that addressed the multidimensional aspects of diversity and inclusion in clinical trials, and the coverage of social unrest with the demand for equity featured in media across the globe.
COVID-19 raises awareness of clinical trials and the need for diversity
The coronavirus pandemic placed clinical research on the global stage, raising public awareness of clinical trials and highlighting the need for diversity and inclusion amid the demand for rapid vaccine development.
The world witnessed how diverse segments of the population were affected by the virus in different ways, demonstrating why medical products in development, such as medications and vaccines, must take into consideration diverse populations to better understand the benefits and associated risks across all groups.
People from diverse backgrounds including race, ethnicity, age and underlying conditions began to vocalise the need for inclusion in trials to ensure safety and protection. Now in the spotlight, industry paradigms have come under scrutiny and this has opened the way for evolution in new ways of working.
Necessity is the mother of acceleration
In the early days of the pandemic, many solutions were initially adopted and the use of decentralised trials was accelerated, providing the adaptability required during uncertainty.
Because of this, the industry now has the opportunity to design protocols that make these new decentralised approaches the standard – creating wider options in clinical trials and also meeting the demand for more diversity and inclusion.
Offering more patient-centric options, such as in-home patient assessments as part of a decentralised or hybrid trial, increases the geographical outreach beyond the city and suburban setting where investigative sites are typically located.
A recent patient survey on decentralised trials conducted by ICON showed that only 10% of respondents were willing to travel more than one hour for clinical trial participation. How many patient communities are excluded simply because of where they live?
More than patient recruitment
It may be tempting to see diversity and inclusion as a recruitment challenge only, however early planning including reviewing the protocol and trial design are as important.
Intense review of the protocol and applying enrichment techniques to the design will ensure a more solid platform to support the process of identifying the right sites, engaging the right communities and ensuring that the population is reflective of the patients who will receive the treatment.
It is also important to continually engage the target patient population to uncover the hidden barriers of participation so that the protocols and trial designs are optimal for the study.
Regulation providing the framework for the future
In November 2020, the US Food and Drug Administration (FDA) issued new guidance to provide recommendations on how to make clinical trials more inclusive for multiple populations, and how to ensure the people participating in these trials represent the populations most likely to use the investigational product.
With this FDA guidance, other regulatory agencies may follow, leading to greater regulatory scrutiny during review. What is not clear yet is how long it will be before guidance becomes an imperative, forcing sponsors to take action rather than encouraging them to adapt their approach and processes. It is likely, but not confirmed, that this could be the start of regulators paving the way to more prescriptive requirements.
Developing a strategy for the future
Establishing a robust strategy based on strong engagement with key stakeholders – patient communities, advocacy groups, physicians, sponsors – is key to embedding a meaningful and effective approach into clinical trials.
Building trust in underserved communities is going to take time – the industry needs to show its long-term commitment by investing resources in communicating and understanding the pain points, whether they are cultural, ethical, mobility or age-related.
If industry commentary is correct, sponsors want to drive this forward and this is likely to benefit patients and society as a whole.
ICON is due to release a white paper on Diversity & Inclusion in June this year. Pre-register now for a copy of the report.
Nuala Murphy is President, Clinical Research Services, ICON plc
