We recently talked with Rosamund Round, VP, Patient Innovation Center and Decentralized Trials at Parexel, about the challenge of improving diversity in clinical trials and what Parexel is doing to meet it. The following is an edited version of our conversation.
What inspired Parexel’s interest in improving diversity in clinical trials?
RR: Diversity is something that has been a focus at Parexel for many years, but the increased industry and societal focus over the last couple of years has really brought it to the fore. In particular, the disproportionate impact of COVID on certain racial and ethnic communities, particularly in the United States, and the rise of the social justice movement, we wanted to make sure that we were addressing this issue thoughtfully and framing it in terms of access to research. In early 2021 we launched our Discussions on Diversity series, beginning with an in-depth research report featuring patient, academic and physician voices highlighting the main challenges of achieving diversity in clinical trials and offering ways to overcome them.
How did you approach this work?
RR: First, we wanted to make sure we understood what the barriers were rather than making assumptions about something that was not the lived experience of many people in our industry. In our research, we surveyed 2,000 respondents across a range of racial and ethnic groups in the United States, Canada, United Kingdom, Australia, France, Hungary, Italy, Mexico, Poland and Spain. The report, representing a combination of qualitative and quantitative data sourced from respondents, identified critical barriers to achieving diversity in clinical trials while offering specific solutions to help ensure more equitable access for Black, Latinx, Asian and Indigenous communities.
What are some of the things you learned?
RR: I often hear decentralized clinical trials (DCTs) being talked about as something of a magic bullet for improving research access. But actually, for all the issues we are solving, it has also uncovered different challenges. For example, we know that trial visits cost time and money, which is challenging for many. One of our patient advisory council members, who's an oncology patient, says she has friends for whom it's literally a choice between oncology treatment or being able to work and feed their children. We thought telemedicine visits could help as it would reduce the time burden of participation to perhaps just 10 minutes out of work. But, actually, if you have multiple jobs, you might not have 10 minutes. And for a patient of lower socioeconomic status, they might not have Wi-Fi, a good data plan, or a cellphone that is suitable for telemedicine visits. So, although the financial burden of travel and work absence are significantly reduced there are news costs to consider. However, with appropriate planning, we can provision devices and associated data plans, which can address this barrier.
And when you provided phones and paid for people’s Wi-Fi, you learned something else.
RR: Yes. One of my colleagues in Brazil reported that some participants at the sites where she is working were leaving their provisioned cellphones at the hospital. They then travelled back there every day to complete their ePROs or eDiaries because they are worried about having an expensive device at home.
What is another proposed solution that you’ve found has surprising ramifications?
RR: Home nurses have been widely utilized across the industry during the pandemic, but a member of our patient advisory council from the South Asian community informed us that there is often a lot of secrecy around illness and disease in her community. A nurse arriving at your home can uncover your illness and create challenges, though this can be addressed by the nurse providing treatment in a nearby hotel, community or office.
When most people think about diversity, they think about race and ethnicity, but you have taken a broader view.
RR: We've been doing a lot of work with the transgender and non-binary communities. Through research and discussions with patients, it is clear that they are often subject to discrimination and, at times, violence. Thinking specifically about this in the context of clinical trials, a recent report in the UK found that almost half of all transgender or non-binary patients said they had experienced inappropriate curiosity by medical staff during medical visits. And one of the members of our panel said that they were in an accident and were rushed to the ER and were more scared about how they were going to be treated by the staff than they were about the injury they had suffered. If you feel unwelcome when you go to a hospital, you’re not likely to seek clinical trial opportunities.
What other groups are we discouraging?
RR: It is important that we consider and accommodate people with disabilities. For example, if you are in a wheelchair, are there restrooms large enough for you to turn around in? Are patient engagement websites and DCT apps enabled for people with visual impairment? There are many differences to be considered and we continue to listen and learn, sharing with industry colleagues through Parexel’s Discussions on Diversity series.
It is evident there's still a lot of work to be done, but I am encouraged by the fact that there is recognition of the importance of diversity in clinical research, and that we are beginning to see progress. The strides we’ve made with decentralized trials is one example on how we are helping to support more diverse patient populations.