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Diverse clinical research starts with the healthcare workforce

Diversity initiatives are a hallmark of clinical research. From US Food and Drug Administration (FDA)-penned guidance and pharma initiatives to years of research showing that diverse trials improve outcomes, researchers have placed ample focus on the importance of diverse trial populations. Diversity is also essential in the clinical research workforce.

Leadership within the pharmaceutical industry remains, despite efforts, overwhelmingly white and male. Female C-suite executives remain rare and account for less than 10% of top leaders in the biotech industry, while nearly 90% of those in executive roles are white. These numbers persist despite goals set by the Biotechnology Innovation Organisation (BIO), the pharmaceutical industry’s largest trade group, encouraging BIO members to hit diversity goals calling for gender, racial, and LGBTQ+ representation.

This lack of diversity in leadership matters: pharmaceutical companies are global, multinational organisations responsible for developing drugs that will be used to treat people around the world. A lack of diversity within these companies may suppress drugs from being developed and studied for a wide range of patient populations. From the boardroom to Research & Development (R&D), the workforce should be representative of the people that the biopharma industry treats.

Increasing diversity in the clinical research workforce may improve diversity among clinical trial participants, healthcare access, and equity of care. Minority participants often cite a lack of trust of researchers – both that the researchers have their and their community’s best interests at heart and that the researchers are honest and transparent about the interventions they’re studying – as a reason why they do not participate in clinical research. The consequences of limited minority participation are broad and far-reaching. For example, certain drugs don’t take into account genetic predispositions among certain ethnic groups for specific diseases, and there is an overall lack of understanding of how drugs are metabolised in bodies that aren’t male or white.

Both current and previous industry initiatives haven’t increased minority research participation to the levels where it should be. So, what’s the next step?

In January 2021, the Association of Clinical Research Professionals (ACRP) announced the formation of its Diversity Advisory Council, a working group dedicated to reinforcing the need for “greater diversity in the clinical trial workforce.” A top priority of the Council is developing strategies to recruit and retain both professionals and students who are part of historically underrepresented groups to “enhance the quality of the existing workforce, as well as improve the overall climate of inclusivity, communication, and cultural understanding among the field.”

According to Jim Kremidas, ACRP executive director, creating a more diverse research workforce will help researchers and sponsors alike build the necessary trust to conduct clinical trials that are representative of diverse communities. He pointed out that this would result in “more equitable health outcomes and employment opportunities.” This trust is founded in culturally competent communication, also called cross-cultural communication and culturally congruent communication. This is the ability of healthcare providers and healthcare organisations to “effectively deliver healthcare services that meet the social, cultural, and linguistic needs of patients.” Culturally competent communication creates a model for communication in a healthcare setting where shared decision making is considered in the context of a patient’s background, leading to better outcomes. And when the clinical research workforce – those in charge of designing and executing trials, as well as recruiting and retaining patients – is already operating from a place of diversity, equity, and inclusion, the barriers to creating culturally competent communication decrease.

Increasing diversity in the clinical workforce goes beyond talk. To create a diverse environment, diversity, equity, and inclusion must be integrated into all organisational processes. Through this, said David A. Thomas, the Naylor Fitzhugh Professor of Business Administration at Harvard Business School, diversity will “become a lens for looking at, identifying, developing, and advancing talent” – rather than a checkbox that a company must tick.

The pharmaceutical industry and the clinical trial workforce should prioritise the diversity initiatives set out by organisations like BIO and company-wide diversity, equity, and inclusion initiatives in a meaningful, measurable way. One way to do this is through a corporate responsibility program that prioritises diversity, equity, and inclusion, empowers employees, and creates an inclusive, human-centric environment. It might seem redundant to conduct research on how to improve clinical research, but some investigators have done just that. Studies published in BMC Medical Education and Ethnicity and Disease both evaluated how the research workforce could promote diversity.

In the first study, researchers developed the Research Education Program to Increase Diversity Among Health Researchers (REPID) research training program at Michigan State University with support from the National Institutes of Health (NIH) and the National Heart, Lung, and Blood Institute (NHLBI), with the goal of preparing students to pursue research across health-related fields. Through an online introductory course and a 12-week hands-on research experience program, participants get research-focused opportunities they may otherwise not have had. This program provides a scholarship, stipend, and housing, eliminating a common concern – a lack of financial availability – that minority students might experience.

The NHLBI also funds the Programs to Increase Diversity among Individuals Engaged in Health-Related Research (PRIDE) initiative to increase the number of working scientists and researchers from under- or unrepresented backgrounds working in the biomedical sciences field. PRIDE focuses on junior researchers, who often cite insufficient time and conflicting work experiences as reasons that prevent them from continuing their academic research careers. PRIDE sessions provide hands-on education and skills training, as well as individual mentoring, in an effort to increase diversity.

Each of these programs is for a specific set of participants. Instituting programs like these within the biopharmaceutical industry isn’t necessarily difficult, but it does require the genuine prioritisation of diversity, equity, and inclusion initiatives. The industry should review current Talent Management practices on how they attract and select their talent and how they can address conscious and unconscious bias to rebuild trust. It’s important to identify barriers in current practices both during recruitment and throughout employees’ careers to ensure that all have equal opportunities to grow. Transparent and rigorous promotion and development systems, as well as long-term plans of investment in education to develop sustainable inclusive practices and behaviors can help attract and retain a diverse pool of candidates.

Better organisational – decision making is fueled by better diversity within an organisation. A diverse and inclusive slate of team members brings differing perspectives to challenges and initiatives and has a demonstrable – and positive – effect on a company’s bottom line. From a business perspective, a diverse workforce makes sense. From a healthcare perspective, employee diversity among decision-makers and drug developers means that clinical research and trials are more equitable, communication with participants is more culturally sensitive, and outcomes more fully represent the truly global world in which we live.

With thought, effort, and intention, the pharmaceutical industry can create a workforce representative of the people it serves. Understanding the current challenges is just the first step.

 

Diversity and inclusion in clinical trials

Paving the way for diversity and inclusion in clinical trials: establishing a platform for improvement

This whitepaper examines the barriers to accessing under-represented subgroups, the regulatory landscape and how organisations are addressing this issue.

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