In 2022, biopharma will continue to invest attention and resources in advancing Diversity, Equity and Inclusion (DE&I), both inside our own organizations and among stakeholder populations, including investigators, participants and patients.
While the need for DE&I has long been clear, it was elevated to a critical strategic priority for the industry as strong movements for racial justice changed our global discussion about equity and the harsh realities of COVID-19 showed the urgency of promoting diversity in clinical trials and everyday access to care.
Change Inside Biopharma
We’re seeing clues that corporate DE&I investment and engagement will continue to be a critical growth area for 2022.
More than 2,000 CEOs joined the CEO Action for Diversity & Inclusion Pledge. In Q2 2019, DE&I initiatives were mentioned in 2% of earnings calls; in the same quarter in 2020 that jumped to 40%. Across the life sciences industry, leaders including Bristol Myers Squibb (BMS), Pfizer,GSK, J&J, Novartis and Roche/Genetech have scrutinized their internal culture and practices, as well as touch points with other healthcare stakeholders and joined hundreds of other corporations in pledging $66 billion to internal and external racial equity initiatives.
Commitment to Talent
One signal of how quickly these pledges are becoming operationalized is the commitment to talent. A Gartner analysis revealed an almost 800% increase in job postings for dedicated diversity recruiters. Amgen, BMS, Novartis and others have partnered directly with historically Black colleges and universities to foster the talent of future leaders; they and others are also building intentional plans‒including accelerators‒to more quickly reshape their leadership teams.
There is also increasing investment in talent pipeline assessments to identify and address potential bias in recruitment processes, from
job postings to candidate screenings to more diverse hiring panels. In addition, significant movement to address equity is happening in the form of transparent public commitments that are based on foundational shifts in gender and identity equity, from compensation to benefits.
As we enter 2022, DE&I programs will be expected to increase their sophistication in both measurement and outcome. While the census of representation by role will continue to be important, we’ll see increasing pressure to improve the ability to measure inclusion and stakeholder impact.
Diversity in Clinical Trials
Another critical growth area will be organizational health literacy, particularly about the critical importance of racial and ethnic diversity among patients enrolled in clinical trials, that all too frequently do not mirror the populations most impacted by the target disease.
These programs will increasingly advance clinical teams’ and sponsors’ understanding of how protocol design may unknowingly erect barriers to enrollment of diverse patient populations.
Look for targeted workstreams and new rituals around recruiting under-represented racial and ethnic patients into trials of therapies and vaccines for diseases with disproportionate impact on these groups.
That education will go beyond the walls of sponsors and partners directly into the clinical trial sites, with training, tools and milestones around recruiting investigators and subjects that mirror the affected patient population.
Changes Across Healthcare
Despite the ongoing challenges of the pandemic, drug discovery and approval has continued at a rapid pace.
In fact in 2020, 53 novel medications were approved by the FDA, the second highest year on record. An additional 42 were approved in the first 10 months of 2021,3 setting up another bold year for healthcare innovation. But, for whom?
The 2020 trials included 32,000 participants. Among them, 75% were White; 8%, Black or African American; 6%, Asian. Those numbers look much like those seen in the five years previous. That's just looking at one lens on diversity, not understanding other critical variables like age, gender, socio-economic realities, sexual orientation, etc.
Despite encouragement and guidance from the National Institutes of Health and the FDA, as well as global healthcare advocates over the past three decades, Blacks and other people of color still make up just one fifth of clinical trial participants. That is far less than the total non-white percentage of the population, according to the latest census data.
During the COVID-19 crisis, this glaring disparity was elevated to headline news. In trials of some leading vaccine candidates, for example, Blacks made up less than 10% of participants at certain points in the development process. Yet, at key moments in the pandemic, Blacks were two to three times more likely than whites to get infected and more than twice as likely to die.
The effort to improve diversity in clinical research dates back more than 20 years. During the pandemic, we’ve seen a lot more attention to this problem, including final guidance8 from the FDA on trial diversity in November 2020 and a commitment to diversity principles from PhRMA. But, despite a renewed focus on patient diversity in clinical trials, the needle has barely shifted.
In 2022, life science leaders are redoubling efforts to dismantle barriers to trial enrollment of underrepresented groups, while upping their game in community education and outreach. The industry is aligned: meaningful inclusion of under-represented populations in drug development and equitable access to commercialized medication is critical to eliminating healthcare disparities, ultimately improving health equity.
New themes emerging in just how to achieve that:
1. Improving depth in the community
From community-based site networks to stronger relationships with community influencers, sponsors are getting out of the "echo chamber" of existing site lists and contacts and out into the patient populations we ultimately serve.
One novel idea shared in a recent interview considered a future role for contact tracers hired during the pandemic. Contract tracing has been a notable disappointment in the US, but legions of workers were trained in these techniques. Could those same nurses and ambassadors be deployed into communities to educate about relevant clinical trials and actively recruit participants who may have not previously considered clinical research?
2. Moving from encouragement to mandates
Change happens slowly when it relies on intentions instead of outcomes. Some leaders are setting strong financial targets for diversity among partners and suppliers. Those mandates are reflected and measured in individual goals, highlighting the effect of individual decisions on collective impact.
In 2022, look for more debate about mandates from key regulators. Will the 1993 National Institutes of Health (NIH) Revitalization Act that mandated levels of subpopulation recruitment in NIH-sponsored trials significant enough to assess differences in outcomes get more teeth? Will the FDA or EMA decline to review research that doesn’t include some
level of epidemiological assessment that was done to ensure that the protocol reflects disease impact?
3. Focusing on diversity as feasibility
A growing element of site feasibility assessments is careful consideration of each primary investigator’s ability to recruit diverse populations. Increasingly, feasibility assessments are weighting sites that are both actively serving underrepresented populations and that have a higher percentage of diverse investigators.
A study from the Tufts Center for the Study of Drug Development10 (CDSS) found that diversity of investigative site staff is highly associated with the diversity of patients enrolled in clinical trials. In addition, investigative sites with highly diverse staff are more likely to view diversity as a critical success factor and to have developed operating practices encouraging diversity.
In the US, one-third of investigative site personnel in academic medical centers and community hospitals and nearly half of personnel in private sector research centers are representative of diverse populations.
In Europe, less than 10% of investigative site personnel are representative of diverse populations.
Increasingly industry voices are pointing to Institutional Review Boards as a critical partner in ensuring that the prevalence ratios in trials are both ethical and supported within the site identification and recruitment design.
4. Training tomorrow’s investigators
No single policy prescription or grassroots initiative will solve disparities on its own—especially considering the links between health inequity and society-wide problems such as poverty, lack of safe housing, underemployment and poor-quality public education.
Some leaders are looking to not only what can be done today, but what can be done more systematically to set a strong foundation for the future. BMS, for example, pledged upwards of $300 million in programs to address health disparities. The funding will go to training clinical investigators from underrepresented racial and ethnic groups
and fellowships for medical students in those communities, among other activities. By 2025, BMS will spend $1 billion globally with Black/African American and other diverse-owned businesses to generate positive economic impact.
5. Improving understanding of the burden of disease
Rare disease leaders have certainly been ahead in using real world data to understand disease progression and impact. Now, more and more researchers are making that core understanding a critical part of study timing and design.
GSK’s efforts start with the premise that diseases and medications affect populations differently, depending on genetic background, ethnicity, sex, age and socioeconomic status. To generate trial data that anticipates real world use of the therapy and likely outcomes, GSK invests upstream— characterizing populations with the highest burden of disease, learning about their barriers to access,
engaging with relevant advocacy groups, embedding the right questions in study protocols and training GSK staff tasked with minority recruitment.
6. Going together
The story of how we build momentum in clinical trial recruitment is unlikely to be told by any one organization alone. Instead, it will be built by clever coalitions, unexpected partners and bold new ways.
Early in the COVID-19 crisis, Roche and Genentech12 drew attention to the mostly White enrollment of patients in clinical trials for promising therapeutics. In May 2020, Genentech Chief Diversity Officer Quita Highsmith and colleagues published an industry-wide call to action aimed at reshaping clinical trial protocols. Similar cross-stakeholder programs have gained strength over the last two years.