Within my working space, I’ve had the perfect position to explore the best practices for reliable trials in research spaces. Across many forms of research, it’s clear that trials with a heterogeneous study population are more generalisable within clinical practice and, potentially, carry greater validity. Whilst heterogeneous studies are the optimum choice, it can be difficult to source subjects due to various societal and historical factors.
So, what methods can we use to tackle diversity and access in our trials? After delving into this briefly in a previous article of mine, I became interested in further understanding what additional support do site managers need from CROs and Sponsors. To begin to truly explore this complex topic, the team at CM Life Science and I brought together a panel of site management leaders from across the field to discuss their approaches to diversifying their organisations.
To open the conversation, I wanted to explore some of the ways our panellists tackled the development of a heterogeneous patient population. For Tiffany Ashton, the Director of Operations at ClinEssentials, she noted logistical struggles in patient attendance being the main obstacle. From socioeconomic factors to complex working schedules and childcare concerns, there is a lot to bear in mind when trying to diversify the patient population. For Ashton, childcare support was essential:
Our clinic used to offer Saturday clinics or provide childcare, allowing us to be more accessible to our community…that [childcare space] could also aid with some of the challenges in getting more patients recruited to the studies at your site”.
On a broader scale, the input of funders and truly inclusive resource planning can make a huge difference for some site managers. Chris Komelasky, CEO and Founder of Sitebridge Research, suggested that a change in the thought process of sponsors and CROs to allow a more holistic delivery of resources to research sites is crucial. Across research and patient delivery, he stressed a need to ensure “that there’s that support system in place” for communities and site managers in supporting diversity and access, and in “making sure that the resources are there not just for study-specific things, but that community outreach [too]”.
In exploring the active steps site managers can take to combat diversity issues, Director of Clinical Research at the South Texas Research Institute, Margaret Leal, placed great success on having a diverse workforce that reflects the diversity of populations you want to work with. “If you want a diverse population, you need to have diverse staff, having the patients see themselves in you, speak like them and look like them.”. She noted that creating a staff that your community feels represented by can encourage them to work more closely with you;
...it’s essential for sites to really get to know their patient population and the demographics in their area…"
Brad Hightower, CEO of Hightower Clinical, added that a continued and honest effort of connection with the full breadth of your community is needed for genuine diversity and inclusive access. He said that you “can’t just show up when you want patients in a study and expect that people will line up for you… you’ve got to be willing to make that investment.”
In terms of collaborative sponsor support in developing a diverse and supported population, Hightower has some inspiring words to offer:
…sponsors need to get used to the idea that they may have to make those long-term investments to put their money where their mouth is. If you want some more diverse sites, you have to be willing to take a chance.”
Our initial discussion revealed the breadth of passionate and innovative teams working across the life sciences sectors. These collectives are at the forefront of developing truly diverse research trials that reflect our communities in their entirety, and conversations such as these are the key to collaboration with integrity that can forge research and development for the future.
If you’d like to hear more of our conversation and explore the panel’s differing approaches to diversity and access development, you can take a look at the full recording here, alongside some more insight and key takeaways in our downloadable PDF, here.
What do you think about the opinions shared here? Do you have any additional points or insights on this topic we haven't touched on? I'd love to discuss them in some more detail. Drop me a message at firstname.lastname@example.org or connect with me on LinkedIn to chat!
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We spoke to Margaret, Chris, Tiffany and Brad about the challenge clinical trials have in becoming more heterogeneous