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

Although the statistics have to change, we’re really pleased that conversations are still happening about the lack of diversity in clinical trials. More reports are coming to light about the lack of ethnicity reporting, and the underrepresentation of ethnic minorities. We hope this evidence and increased awareness will help bring changes not just for individual clinical trials, but across the whole industry.

COVID-19 clinical trials are failing to enrol diverse populations

It’s commonly been reported that COVID-19 is disproportionately affecting people from ethnic minorities. But it’s also clear that, so far, COVID-19 clinical trials are failing to represent these populations. Hala Borno, an oncologist at the University of California, recently co-authored a study regarding the racial and ethnic makeup of trials within the US. This research found that a third of clinical trials didn’t report race or ethnicity data. And of those that did, Black patients were underrepresented relative to disease burden. So, this problem is clearly not unique to COVID-19 clinical trials. Dr Borno said, “I think that if we do not ensure diversity in these COVID-19 clinical research studies, we may ultimately render interventions, whether it be drug or vaccines, that do not uniformly demonstrate efficacy across populations, or have side effects that we only capture later on.”

While there have been a lot of strategies that shown promise, it’s absolutely essential to consider two buckets: community outreach, and strategies at the investigator sites themselves.

Read the full discussion with Hala Borno and STAT news, here.

Overcoming gender and sex disparity in cancer trials

It’s important that clinical trial populations closely mirror the people who will ultimately receive the treatment. Despite increases in the numbers of females taking part in clinical trials, they are still very much underrepresented in cancer clinical trials. This is even more apparent among older women in the US.

A recent review of gender and sex disparities in cancer clinical trials found that the barriers to participation are often not unique to women, but women may face misperceptions from sponsors and site staff that they are more difficult to recruit or less likely to want to take part.

Improvements to recruitment and retention strategies are needed to further the participation of women, such as educating physicians regarding gender disparities and partnering with prominent stakeholders within communities.

Read the full review article

Strategies to reach more racial/ethnic groups

This review concentrates on the challenges with enrolling diverse populations onto clinical trials and how best to overcome them, using strategies that build bridges between research and participants.

The top five major challenges covered in the review are:

  1. Low income as a barrier to participation
  2. Investigator bias
  3. Medical mistrust
  4. Limited health and research literacy
  5. Lack of access to transportation

To learn more about these and the three proposed strategies covering cultural competence, and financial and transport support, read the full review.

Improving diversity by starting within

Women of Color in Pharma (WOCIP) recently hosted a roundtable for 10 study sponsors and CROs about equality in biopharma.

  • Only 20% of those who attended said their corporate plans were specific and intentional to be inclusive and diverse.
  • 44% said they are unsure whether there will be promotions for women of colour in their businesses.

These statistics have got to change to truly improve diversity within the industry. Companies need to reassess their own diversity and inclusion initiatives with employees alongside working on external strategies to improve diversity in clinical trials. Shamika Williams, full-time lead for BMS’ Black Organization for Leadership & Development (BOLD), said BMS is planning to recruit 250 clinical investigators from diverse backgrounds to work in highly populated areas where potentially underserved trial subjects are located.

“We’re going to mentor them,” Williams said. “We’re going to put sensitivity training in place that they need in order to make sure that they are asking the right questions and are thinking holistically about what’s happening with this individual and in this community. That’s going to be critically important to enable the success of these programs.”

Read more

7 ways to reduce gender disparities in clinical trials

Research suggests that women are more likely to suffer adverse side effects of medications than men, highlighting a disparity of representation in clinical trials. A recent study found that women experience side effects nearly twice as often as men, and the authors have recommended seven ways to correct this disparity.

  1. The FDA should share pharmacokinetics (PKs) data that were submitted as part of a current drug’s approval process on their website.
  2. Evidence of sex differences in PKs should be made available on drug labels and websites such as WebMD.
  3. The initial dose of drugs with higher female PKs should be lower for women than men.
  4. The FDA should require all empirical non-disclosure agreement data to be accompanied by documentation of statistical analyses, which should meet requirements for publication in a peer-reviewed journal.
  5. The board certification process for healthcare providers should include an appropriate understanding of the clinical relevance of sex-differences in drug treatment.
  6. The Department of Health and Human Services should establish sex parity as a long-term goal in the drug approval process.
  7. Pharmaceutical companies should pay more attention to sex-appropriate dosing, beginning in the early drug development phases.

Get more detail on the recommendations here.

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If you would like any of your articles featured in the next round-up, email us at ash@demanddiversity.co

15th September 2020

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