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May 2020: diversity and inclusion in clinical trials round-up



Recently, the demand for diversity in clinical trials has been clearer than ever. And it’s obvious that there’s so much more to be done. In this monthly round-up, we’re bringing you the latest news that have been both eye-opening and inspirational, to highlight the work that’s being done – and what still needs to be done – to push for more diversity in clinical trials. Take a look…


We can’t truly move forwards until there’s equality between sexes


This article highlights the underrepresentation of women in clinical trials, and how we can’t truly move towards personalised healthcare until there’s a balance between men and women taking part. What’s more, eight out of ten FDA-approved medicines pulled from the market showed higher levels of harm to women than men. This article brings more examples of the imbalance in research, and how there’s still a way to go in understanding and addressing the differences between men and women for clinical trials.


A new coalition – reducing racial disparities in rare disease


In May 2020, the Black Women’s Health Imperative announced the formation of a new coalition focused on reducing racial disparities in the rare disease community. Let’s take a closer look at the current landscape:

  • An estimated 30 million Americans have a rare disease

  • It can take an average of five years and consultations with over seven clinicians to reach an accurate diagnosis for a rare disease

  • Only ten percent of rare diseases have a treatment approved by the FDA


The coalition will identify and advocate for evidence-based solutions to alleviate the disproportionate burden of rare diseases on communities of colour. Find out more about the coalition and their aim, here.


Extending awareness beyond awareness week


In light of Clinical Trials Awareness Week, this article shares insights from Dr. Gary Puckrein, president of the National Minority Quality Forum, to help us learn more about the importance of diversity in clinical trials. This includes stats around the lack of diversity, and the outcome risks if barriers aren’t eliminated. But most importantly, the article ends with three steps for how we can learn and take action: (1) get informed, (2) share the information and (3) act and seek out resources that embrace diversity in clinical trials. Read more, here.


Ten-year trends


This study looked at the 10‐year trends of participation of women and minorities in pivotal cardiometabolic trials supporting the approval of new drugs from January 2008 to December 2017. The results showed that persistent sex disparities remain, with women being inadequately represented in these trials. And racial minorities, particularly black people, have continued to be underrepresented in study trial populations, with participation rates remaining unchanged over the time frame studied. It’s clear that further efforts are needed to enhance the representativeness of clinical trials according to race and sex.

Read the full results of the study.


A call for inclusion


The lack of diversity in research has been highlighted in the current COVID-19 outbreak. This article goes on to explain that African Americans, Hispanics and other underrepresented groups have faced greater risk of COVID-19 infection and have experienced significantly higher hospitalization and mortality rates. Further, that the death rate from the virus is double among African Americans and Hispanics vs Caucasians. That being said, Genentech’s Medical Affairs team sprang into action, to treat a high proportion of underserved and minority patients and quickly developed a randomized, placebo-controlled study called EMPACTA. Read more about it, here.


Janssen’s plan for success


Since 2019, Janssen has had a diversity and inclusion in clinical trials initiative in place. However, their new initiative now allows the company to apply the approach across the entire organization, moving from a one-off approach, to instead embedding it as a way of working. The recent LOTUS trial conducted by Janssen provides a glimpse at how the initiative can work to help the company accomplish its diversity goals. Read more about their plan for success and how they’re educating patients and sites, alongside building trust.


The SCRS Diversity Awareness Program:

supporting sites to improve diversity enrolment


It’s no doubt that diverse enrolment in clinical research studies is a complex issue, and there are many challenges and implications for clinical research sites to overcome. With that in mind, the Society of Clinical Research Sites (SCRS) started the SCRS Diversity Awareness Program. The goal of the program is to educate, inform, and heighten awareness of the importance of establishing best practices that support diverse trial enrolment in support of the research site. This article highlights what they’ve been up to over the last four years, and the resources they’re building to support research sites.

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