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.
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:
Low income as a barrier to participation
Limited health and research literacy
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.”
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.
The FDA should share pharmacokinetics (PKs) data that were submitted as part of a current drug’s approval process on their website.
Evidence of sex differences in PKs should be made available on drug labels and websites such as WebMD.
The initial dose of drugs with higher female PKs should be lower for women than men.
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.
The board certification process for healthcare providers should include an appropriate understanding of the clinical relevance of sex-differences in drug treatment.
The Department of Health and Human Services should establish sex parity as a long-term goal in the drug approval process.
Pharmaceutical companies should pay more attention to sex-appropriate dosing, beginning in the early drug development phases.
A lack of female investigators may be related to underrepresentation of women in heart failure trials
New research led by Penn Medicine has found that less than 20% of first authors on manuscripts cited to support the highest recommendations in heart failure treatment guidelines were women, and less than 15% of the senior authors were women. Interestingly, the researchers also found that clinical trials with higher proportions of women authors had a higher number of female participants.
"Diversity in authorship can have a snowball effect across the field--not only in improving gender equity in cardiovascular medicine, but also perhaps in reducing the underrepresentation of women in clinical trials," said Nosheen Reza, MD, the study's lead author. Dr Reza explains these findings could be because women are more likely to want to take part if approached by a female investigator, or that female investigators encourage women to take part more than male investigators.
A roadmap to improve trial delivery for underserved groups
A new article published in Trials describes a multicomponent workstream project to improve representation of underserved groups in clinical trials.
Within the project, three main strands were used to generate goals, workstream plans and a strategic roadmap for future development:
Literature review to identify barriers to trial participation
Surveys to refine initial findings and identify good practice
Workshops to reach a consensus between stakeholders on definitions, barriers and the roadmap
The project led to the identification of four key goals that will be addressed over the next year:
Building long-term relationships with underserved groups
Developing training resources to improve design and delivery of trials for underserved groups
Developing infrastructure and systems to support this work
Working with funders, regulators and other stakeholders to remove barriers to inclusion
Toolkit for inclusivity within clinical trials
The Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women’s Hospital and Harvard University has released new guidance documents for inclusion and equity in clinical research. The mission of the MRCT Center is to engage diverse stakeholders to define issues in clinical trials and to create and implement solutions to improve clinical trials. The new document presents the basis for improving diversity in clinical trials, explores barriers to the inclusion of diverse populations and outlines an approach and toolkit to overcome these challenges.
Barbara Bierer, MD, Faculty Director of the MRCT Center said, “We appreciate that the guidance is a living document, one that will grow as experience and considered analyses inform successful approaches.”
Disproportionate number of ethnic minority patients included in remdesivir trials
In a new article in the NEJM, we’re seeing yet more reports of disproportionate representation of ethnic minorities in COVID-19 clinical trials. Remdesivir is being used to treat COVID-19 across the US, but data supporting its efficacy and safety in ethnic minority groups are limited.
Data on race and ethnicity were not provided for the 53 patients treated with remdesivir under the “compassionate use” program
Black Americans accounted for only about 20% of the 1063 patients in the placebo-controlled Adaptive COVID-19 Treatment Trial
In a Gilead-funded study, only 11% of the 397 patients were Black, who were randomly assigned to 5 or 10 days of remdesivir
LatinX and Native American patients were also underrepresented or ethnicity data not reported
To read more about the disparities in these clinical trials and for possible barriers and solutions, take a look at the full article here.
The path to solving unconscious systemic bias in clinical trials
In this article, Lori Abrams, Executive Director of Patient Advocacy & Diversity, WCG, talks about how unconscious bias within certain ethnic communities does indeed exist and how it can potentially be resolved.
There are lots of factors that lead to underrepresentation of ethnic minorities in clinical trials and these occur at the sponsor and site level:
A lack of diverse community involvement early in study planning
Patient insights not being collected or used to inform protocols or recruitment strategies
Geographic locations of sites
Unconscious bias at sites
Lack of ethnic minority staff within sponsors and sites
Limited knowledge or training about culture
Lori goes on to present solutions to these issues, including creating and supporting centres of excellence with large populations of ethnic minority staff and patients, pairing community hospitals with leading academic hospitals, and community outreach to encourage participation.
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