Research resolutions

Diversity remains high on the agenda for those designing and delivering clinical trials with the aim of bringing new treatments and medicines to market.

Laura Bousfield, interim National Research Delivery Director with the National Institute for Health and Care Research (NIHR), reflects on how the narrative is changing around study planning and site selection to drive diversity and benefit patients.

The diversity challenge

It is well documented that diversity in clinical trial participant cohorts is critical in achieving scientific accuracy and ensuring healthcare solutions are equitable and effective for everyone. For instance, we know that different genders and genotypes may metabolise drugs at different rates.

Our ageing population presents a similar concern; the need to better understand how age impacts new healthcare solutions is becoming ever more urgent.

Yet eligibility for trial participation of this demographic is significantly impacted by their likelihood of having multiple long-term conditions that result in them being excluded.

UK research regulatory bodies – the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) – are developing a set of questions and supporting guidance that will aid researchers in increasing the diversity of people taking part in clinical trials.

Similarly, the World Health Organization recently issued guidance for making clinical trials more inclusive. Last year the Food and Drug Administration in the United States released draft guidance on diversity action plans. With these changes one thing is certain: inclusive science is better science.

However, achieving this goal is a multifaceted challenge requiring consideration at every stage of the research process.

Balancing diversity and delivery

A trial’s protocol design and recruitment strategy are where we typically see a specific focus on inclusivity and diversity.

For example, it is not uncommon to see traditional, site-based recruitment strategies being supplemented with digital tools and techniques to reach a wider pool of participants.

But to be truly effective, our inclusivity efforts need to be a thread that runs throughout each study from planning, to protocol design, to publication. If not, individual steps towards greater inclusivity risk being undermined.

We should be continually asking questions like: Is there a more inclusive way of doing this? Are the processes we use to make decisions inclusive? Are there cultural or inherent ways of working that could potentially take my trial down a less inclusive route?

One commonly cited barrier to diverse research participation is requiring participants to be English speakers to ensure fully informed consent is achieved, or for safety reasons. But there are other, less obvious, examples.

For instance, NIHR data on site selection confirms that pre-existing relationships continue to have a significant influence on study placement decisions for commercial study sponsors.

Understandably, returning to familiar sites can provide an element of confidence and predictability – two things commercial sponsors value greatly. However, ‘same sites’ can also mean ‘same demographics’ and could result in underrepresentation of some groups.

Using data to unlock new locations

Incorporating new and different sites into a research delivery plan is one firm step in the direction of diversity.

In the NIHR we are also encouraging study sponsors to change the narrative. The language we use in study placement conversations has evolved from talking about research ‘sites’ to research ‘locations’, to reflect growing emphasis on ensuring trials are representative of those most in need.

It forces us to think about where those people are geographically located – and which health services they access through which care setting – before we think about the organisations to engage.

Overlaying data can help find your ideal research locations. Consideration of disease prevalence and ethnicity data are not new in site selection.

Both are helpful but only provide part of the picture. Indices of deprivation data and socioeconomic scores can provide additional insight into where underserved communities may be and help identify the sweet spots for recruitment that offer diversity.

But how do you quickly assess which health and care service providers in those locations are best placed to deliver research within your timelines? Opening a new site has time and money implications for commercial sponsors.

The challenge lies in acquiring intelligence that assures you there are organisations in those locations with the desired research delivery capabilities and capacity.
Thankfully, these decisions are no longer a leap of faith.

Apply a research experience filter

Our Scoping Locations for Research Tool has been designed to enable direct comparisons of prevalence, ethnicity and socioeconomic data alongside research activity data.

For the first time, commercial sponsors can use this tool to identify which areas of the country have demographics that match their study criteria, then view relevant research experience for the health and care providers in those locations.

It also highlights areas of potential, for example, where a non-commercial research site could provide the missing asset your commercial study needs.

This single, self-service dashboard is available as a prototype to anyone seeking to access research capacity and capability in the UK. While it is free to use, this resource is funded by the public to drive data-driven decisions that increase their access to research opportunities – a win-win.

By following a few simple steps, you can filter the data to provide a customised view specific to your research needs.

In addition to viewing the volume of previous similar studies and recruitment numbers, the tool also suggests how many sites you will need to reach your participant target.

You then have the option to request more in-depth expressions of interest from research active organisations in the knowledge that you are focusing your study planning efforts in the optimal locations.

At the NIHR we are excited about the potential of this tool. At the prototype stage it provides insight to support decision-making. In the future, could artificial intelligence take us further and recommend the ideal site list for a study? It’s food for thought.

Your New Year research resolution

Beginning site considerations with this countrywide view is undoubtedly a more inclusive starting point than beginning with a ‘who you know’ filter restricting your options.

Starting or supplementing your study planning and site selection processes in this way will contribute towards diversity end goals.

And there are other potential benefits. Data-enabled study placement can mean quicker recruitment and better distribution of research countrywide, which means more equitable access to research for patients.

It also enables optimisation of all research resources and capability across the UK, which speeds up research for all.

Relationships with sites and familiarity are important and bring their own set of benefits to research delivery planning.

Our aim of aggregating our research activity data in this way is not to supersede what works now, it is simply to improve the visibility of the whole system capacity and capability.

At the NIHR we believe doing one thing differently, and making incremental changes, can lead to long-term improvements and inspire further innovation.

We are keen to work in partnership with life sciences companies to explore how we can modify old habits and hopefully create some new ones for 2025.