Over the last few years, the topics of diversity and decentralization have become increasingly important in the world of clinical trials. But traditionally it’s been thought that the two don’t go hand in hand.
However, if properly planned, decentralized approaches have the potential to open rather than close doors when it comes to clinical trial diversity.
The Reuters Events webinar ‘Bridging the digital divide for improved patient diversity’ chaired by Craig Lipset saw four experts discuss the topic of decentralized clinical trials (DCTs) and diversity:
- Dr Mert Aral, Huma’s Chief Medical Officer (R&D)
- Jasna Tholens, Global Director Clinical Trial Management at Johnson & Johnson
- Lashell Robinson, Director, Diversity & Inclusion in Clinical Trials at Takeda Pharmaceuticals
- Michael Zaiac, Head of Medical Affairs at Novartis
Watch the full webinar on demand
So what did we learn from the expert panel? Here we share our highlights from the discussion.
Start with the patient
In her opening remarks, Takeda’s Lashell Robinson highlighted the need to understand the patient before designing DCTs to ensure you don’t set up a trial that creates a digital divide from the outset. She said that ‘diversity means a lot of different things depending on the audience’ and those designing trials need to look at the disease epidemiology and who the patient is, for example, their age and any comorbidities they have, in order to understand what diversity looks like for each trial.
Huma’s Dr Mert Aral reinforced these points when commenting on the use of AI-driven inputs in DCTs. He added that participants need to be looked at as collaborators, offering their unique insights into the feasibility of measurements and protocols to ensure trial success.
“Understanding the perspective of the patient with regards to their condition, the disease burden, how much they’re willing to do, how much they’re willing to engage with that specific technology, how often we should be collecting that certain data point and the usability of the sensors and wearables. Understanding that from the get-go is absolutely essential, and considering these factors early on will lead to more success.”
Take steps to prevent digital exclusion
Whilst technology has the power to reduce health inequalities without careful consideration it can also widen them. Dr Mert Aral discussed Huma’s continued focus on ensuring ease of use and accessibility when deploying solutions for digital-first care and research.
“Creating multiple means to enable enrollment and participation from all backgrounds and geographies to broaden access is key. That means having a web version interface for example, for those who do not own a smartphone, or the ability to activate call centre support dashboards for research teams, where participants can actually call in and submit data.”
He also spoke about how Huma had built functionalities in its platform to ensure those with disabilities that may prevent them from using any technology still had an opportunity to participate in DCTs. “We actually created a proxy functionality whereby a carer or family member can become a proxy for that individual and still sign up for the DCT and submit data on behalf of the participant.”
Embed diversity into your practices
The panel discussed the need to move away from seeing diversity as an initiative, or something we only focus on in relation to awareness days or events and begin to realise its good for business.
Novartis’s Michael Zaiac suggested that companies should start to build clear targets for diversity as they do for any other business objectives. He said: “If we tackle a business problem we give numbers to it, yet with diversity and inclusion we have awareness days and months, which are great, but we never measure and we never have clear targets of what we want.”
According to Johnson & Johnson’s Jasna Tholens, one way for companies to begin to tackle diversification in clinical trials is to break down the process into simpler, smaller steps and create a clear roadmap. She also highlighted the role of diversity in every phase of drug development, from preclinical development to the mature life cycle of the product, and the growing need to analyse the real-world evidence collection to understand which patient populations really benefit from the product.
Digital tools must still build trust
A vital stage for all clinical trials is the consent process. It offers patients an opportunity to address myths and ask questions about the trial and build rapport and trust with the clinical team. Lashell Robinson discussed the importance of ensuring decentralized clinical trials also provide the same opportunities through eConsent.
She said: “One tool that I would really like to see more broadly used in a consistent manner is eConsent. Because that is the critical moment where the patient is either able to build that rapport with whoever is consenting them, or it completely removes them from the clinical trial process. When I think about building trust, that consent piece is really critical.”
When discussing how to make sure an eConsent strategy supports diversity and inclusion, she emphasised the value of using data to drive these decisions. “When we're doing site selection, and we're thinking about where it actually fits our sites, we can use data to figure out where we actually increase that accessibility. But we can also take that feasibility process to really gauge a site’s capabilities and fill in those gaps around eConsent.”
Is decentralization the solution for clinical trial diversity?
Whilst the panel agreed that the decentralization of clinical trials alone was not the solution for diversity, Novartis’s Michael Zaiac suggested that decentralized clinical trials offer a way to address current inequity in access to clinical trial sites and people having the time to participate.
On decentralized clinical trials, he said: “It's one of the tools to address the issues of inequity we are having now. It's not the remedy for everything but I think it's a step in the right direction. And paired with other measures of site diversity, diversity of the site staff, good education etc. it’s the right way forward.”
Find out more about Huma’s award-winning technology to support decentralized and hybrid clinical trials.
