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Transforming Clinical Trials

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June 10, 2022

Tackling Clinical Trial Diversity

Here’s what I learned during the SCRS Diversity Site Solutions Summit

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      Photo of Kelly Brown

      Kelly Brown

    Making clinical research a care option for people who really need it is a big, lofty goal. And during the recent Diversity Site Solutions Summit held in Austin, Texas, I became aware of just how aspirational, nuanced, and complex it is. Without significant systematic changes, the risk is that while more people may be aware of clinical trials, underserved populations will continue to be left behind.

    The good news is that there was a lot of discussion and a general desire to tackle obstacles standing in the way of participation in clinical trials. It is the leadership from organizations like Society for Clinical Research Sites (SCRS), host of the first-ever Diversity Site Solutions Summit, that will foster collaboration across stakeholders to work together.

    Here are a few of my takeaways from the conference.

    Accessibility. Equity. Inclusion.

    There was a lot of discussion of three ideas during the summit: accessibility, equity and inclusion. And what’s important to recognize is that these three ideas must be aligned to advance clinical trials and healthcare overall. For example:

    • More local physicians engaged with the local community is a way to increase awareness, build trust and improve accessibility to clinical trials.
    • Government-funded healthcare (which may be more of a consideration in the United States than in other countries) needs to allow for clinical trials as a care option to reduce the barriers for vulnerable and poor communities.
    • Inclusion as a driving principle in clinical trial design is a more positive way to approach the challenges of diversity.

    It’s not news that the majority of clinical trial participants tend to be white men. And yet, drugs and treatments respond differently in different racial groups, such as asthma and blood pressure.

    During the Diversity Summit, former US Surgeon General Jerome Adams talked about the example set by Operation Warp Speed, a cross-departmental initiative in the United States established to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. It was interesting to hear the backstory from someone directly involved and how they applied pressure on the pharma companies so that the COVID-19 vaccine trials had diverse representation. Yet, for this successful example with the weight of the U.S. government behind it, it shows the need for more inclusion in clinical trials and healthcare equity overall. To make the point, Adams included a quote attributed to Martin Luther King Jr., “Of all of the forms of inequity, injustice in health care is the most shocking and inhumane.”

    Without commitment and accountability, accessibility, equity and inclusion run the risk of becoming checkboxes rather than shaking up the status quo. For example, it was discussed that merely putting research sites in a local community won't improve enrollment from underserved populations. Rather, it is the right people who are locally engaged and can build trust, who will help attract more diverse participants. And there is the trap that “representative diversity” can create a checkbox for diversity instead of really tackling the problem of making clinical research a care option for everyone.

    If anything, I hope the industry rises to the challenge of inclusion. The reality is that many companies use the census to ensure racial and ethnic representation in clinical trials that matches disease prevalence. This approach, although an advancement, is not an innovation. Accessibility, equity and inclusion, if done right, will lead to representative, statistical diversity in a way that brings along more humans without leaving behind individuals who are excluded on the basis of not being part of an underrepresented race or ethnicity. Hence, the focus on inclusion in this blog.

    A Snapshot from the Summit

    Watch this video where we have a quick chat with Christine Narro and Isabel Brugman, both from Latinos in Clinical Research, and Lauren Stockwell of Clinical Research Fastrack. Hear their perspectives at the Diversity Site Solutions Summit in Austin.


    Bigger than Any One Patient

    There was a lot of discussion about “someone who looks like me” as key to engaging local communities. Now I don’t just mean physically – though that is a consideration. When you unpack “someone who looks like me,” it can take on so many different forms. It is probably better stated as “someone who understands me.” Healthcare in general and clinical research need an empathetic approach. It starts and ends with people – people who need care and people who deliver care. It means people from all walks of life, regardless of socioeconomic status, education or literacy levels, gender identification, geographic location, native language, age or race are presented with clinical trials as a care option for their illnesses.


    It really is the shift that the industry has talked about for a while – being patient centric. It’s not about meeting enrollment figures; it’s about offering a standard of care for sick people. It’s about helping volunteers understand how they are contributing to the greater good – and what’s in it for them. It’s not being “a number” in a clinical trial towards the goals of hitting recruitment targets; it’s making each and every person feel like they are part of something bigger than themselves.

    Research Staff Humanize Clinical Trials

    Sites are critical to accessibility, equity and inclusion. The staff at research sites are the people who humanize clinical trials. If anything came through clearly at the Diversity Summit, it is that sites should not be afraid to ask for what they need. Site sustainability is a major concern in the industry, which can be summarized in three main areas:

    • Recruiting
    • Finding new trials
    • Increasing operational efficiency

    Like most other industries, sites are facing a high turnover of staff, which can impact the quality of service to patients. Communication remains a big opportunity – and yet is still a big challenge. To address the situation, CROs and sponsors are pushing “helpful” technology to sites, which is simply adding to the site burden. The message during the summit from sites was: Ask us what we really want.

    Communication is even more critical when it comes to research-naïve sites and investigators. The fact remains there are not enough investigators. And the struggle is that more local investigators and others – nurses, labs, pharmacies, etc. – are key to accessibility, equity and inclusion. Yet, they need more support and direction than sites that specialize in research, which makes communication critical to trial success.

    Clinical research is different than regular medical care. Volunteers need to feel connected with the research team and invested in participating. In the end, we are all human. Connecting clinical research as a care option is creating opportunity for a basic human right – health. I look forward to the actions that will come from the discussions had at the Diversity Site Solutions Summit. For our contribution, there are a few things Teckro has in the works to contribute other points on the diversity conversation… more to follow on this.

    Photo of Kelly Brown

    Kelly Brown