The R&D ecosystem is tasked with developing medicines that will help improve the health of people around the world. Yet often the patients participating in clinical trials are not representative of the population impacted by the disease that is being studied. To safely bring medicines to all people, clinical trial processes need to evolve to achieve the appropriate participant representation.
Diversity and inclusion (D&I) efforts in clinical research and development are not new. At one time, drug study participants were predominantly white men, but global events of the last 18 months have resurfaced the urgency for equity in healthcare and a renewed interest in ensuring that clinical trials are available and mechanisms are created to better engage with underrepresented communities.
To help address the challenge, TransCelerate BioPharma recently relaunched its Diversity of Participants in Clinical Trials Initiative, which aims to equip sponsors and other stakeholders with actionable tools and resources necessary to improve outcomes for diversity of participants in clinical trials. Subject matter experts already involved in their individual company’s diversity efforts are passionate about sharing their knowledge with participating TransCelerate Member Companies.
The Diversity of Participants in Clinical Trials Initiative completed a comprehensive landscape analysis and identified opportunities to focus TransCelerate’s collaborative efforts. The following components are planned for TransCelerate’s first phase:
- Clinical Research Diversity Collaboration Hub. This “one-stop shop” will collect and share information and insights across participating Member Companies, and include diversity roundtable events, experience-based guidance for sponsors, a diversity regulation landscape assessment, and development of a pragmatic toolkit inclusive of templates and tools to be leveraged by the broader ecosystem.
- Race & Ethnicity Enrollment Data Benchmarking. TransCelerate Member Companies will work to identify priority disease states with disparity between disease prevalence and clinical study representation among racial or ethnic groups to establish a current state benchmark for tracking future progress. Member Companies have expressed interest particularly within oncology, and autoimmune, cardiovascular, and metabolic diseases.
- Leveraging Proven Solutions. This initiative will seek to continue to enhance practical solutions that have already delivered for clinical research use with diverse populations. For example, TransCelerate’s Patient Experience Initiative’s Study Participant Feedback Questionnaire has been implemented in multiple global clinical trials. Since its release in 2019, it has been translated into over 15 languages for use with multiple patient populations.
- Best Practices for Sponsors & Sites. As part of earlier efforts to promote awareness of the need for greater representation in clinical trials, TransCelerate released comprehensive guidance in 2015 for sponsors and sites to improve recruitment of diverse populations.
As Head of Global Clinical Development Operations at Bristol Myers Squibb (BMS), I am responsible for overseeing all operations associated with clinical trials and help lead BMS’ enterprise-level approach to D&I efforts. I also serve on TransCelerate’s Board of Directors and am a champion of this new initiative.
For those organizations that are looking to establish or accelerate their D&I efforts, the rest of this post will offer tips and points that the global R&D community can consider.
- Improving diversity of participants in clinical trials is a marathon, not a sprint
Simply put: Working to improve biopharmaceutical R&D diversity is not for the faint-hearted. It’s not easily understood as there is not an easily identifiable root cause. Consequently, there will never be one solution, tool, or organization that can fix everything.
People tend to desire quick results. Yet improving diversity and modifying the existing operational structures will take time. It is going to take a multitude of tools and approaches to make progress and it’s impossible to benchmark what approach (or combination of approaches) will cause any improvements. That’s what makes it difficult.
Increasingly, global Health Authorities are asking such questions as “What was the diversity of your patient population?” or “Did it marry to the incidence of disease in those populations?”
Taking the marathon analogy a step further, these efforts are like a relay race. We are all dependent on each other to make any significant progress. It is the responsibility of companies and consortia like TransCelerate to afford forums for discussion amongst different stakeholders. There should also be discussions amongst different organizations to ensure that efforts across the industry maximize their potential and use scarce resources as efficiently as possible. Anyone addressing these challenges should be asking “Where can we play an augmented role to things that are already being undertaken?”
- Have a dialogue with Health Authorities regarding patient diversity
We are not at the point where Health Authorities can mandate sponsors to meet diversity targets without delaying clinical trials by years. But Health Authorities have taken a responsibility to ask these questions and stimulate pharmaceutical and biotech companies to evaluate their methods to ensure the opportunity of participating in trials is as broad as possible.
Combined with the need to scientifically answer their questions and society’s request for healthcare to become more equitable, the time is now to “catch the lightning in the bottle” and create a platform to engage in these conversations.
- Think globally and analyze the barriers to equitable representation in trials
Take an enterprise-level view of diversity and inclusion at your company. Have a global view, even if your organization mainly operates in the United States. Diversity ripples around the world.
There is always the risk that an approach developed in one country may not resonate in a different country. Legally, you might not be able to ask specific questions. But it’s more important to understand the multitude of issues and then find ways forward to address them.
What are the barriers to recruitment, education, awareness, and access? Unconscious bias is a major culprit. Work to ensure that your messaging, tools, and techniques are readily accessible in a culturally relevant language for the communities you are serving and think about how to address unconscious bias within your organization and within the external collaborations you work with.
The global R&D ecosystem should also look towards sexual orientation and disability representation in clinical trials. These populations face barriers that need to be considered and understood, possibly even requiring varying tools and techniques to address these differences.
- Incorporate sites and partners into the diversity plan
Sites are the epicenter of the clinical trial process. As a result, there is an opportunity for them to educate sponsors on what works well in their environment and community for their patients.
During study start-up, don’t rely on the same investigators. Encourage principal investigators to consider selecting someone else from their teams to reach a deeper level of diversity in your investigative pool. Physicians should look and have the same cultural background and language capabilities as their patients.
At BMS, we are trying to attract patients in geographic areas where they feel comfortable going to clinics, considering their socioeconomics. Patients must feel comfortable going to the clinic and not have it be too much of a burden on their everyday responsibilities. What support can you provide at clinics to facilitate a working parent bringing their child with them?
Many sponsor organizations will select a CRO partner to support the execution of the trial and it is important to apply the same requirements you have within your organization to a potential partner as it applies to them. Sponsors have already started to ask CROs to present their own enterprise-level diversity and inclusion plans. They might choose different measures but hold them accountable, just as you would to a GCP compliance metric or a study recruitment metric.
For partners (vendors and support services), ensure that they have a comprehensive diversity and inclusion program within their own operations and that they act on it. Is there a way to use an organization that focuses on diversity, for example, a women-only clinical trial vendor, as part of your network? Again, it goes back to the point that everyone must do their part to make any progress.
- Put the patient first
Even with these efforts, sponsors and other stakeholders still need to appeal to patients to enroll in a clinical trial. Outreach is essential. What methods do you use? How do you educate the community? Is it through signage, marketing materials, newsletters, social media? It is important to develop an understanding of your audience and go where they are.
You’ll also need to ensure that the messaging resonates. Some things to keep in mind when crafting informational materials:
- Writing comprehension. Are you writing at the right level based on the reading comprehension of the public audience?
- Cultural relevance. Are you using the correct language and dialect? For example, Spanish has 10 different dialects alone. Consider whether your imagery is relevant as well.
- Appeal to decision makers. Depending on the cultural makeup of a family, the decision makers for patients in clinical trials may differ. Matriarchs are often the decision makers in a Hispanic family. Filial piety plays a large role in Chinese families. Once you identify the audience, choose the messaging platform and style of language that will resonate the most in educating the family.
- Commit to the cause publicly
For large organizations and sponsors, it’s motivating to stick to a diversity program if they are being held publicly accountable. Companies should set metrics for each of the facets of the business that promote diversity and inclusion, and then publicly announce where they are against those objectives, as recent reports from Pfizer and BMS illustrate.
BMS just released its first global diversity and inclusion report that details our efforts and future commitments. BMS and other sponsors have an obligation to start selecting sites in areas where there are underserved populations in need of health care. BMS has made a commitment that 25 percent of our U.S. sites in its registrational programs will serve an underrepresented population.
- Fan the flame
We have an obligation as pharmaceutical leaders to keep the flame going. As mentioned, this is a years-long effort with incremental gains. We may not have quick wins, but the continued effort is essential. If we don’t include a diverse patient population in our clinical trials, we do not have a full scientific answer to the health questions we are trying to solve. Beyond the science, it is fundamentally the core to being a responsible corporate citizen.
For those responsible for D&I teams, it is crucial to be patient and find ways to motivate people to continue the journey. This cannot be a standalone five-year project, but a constant effort of organizations, and infusing diversity principles into your culture. Share any returns on investment with your teams and the company, no matter how small. The most successful teams will feel valued and recognized for their efforts, motivating them to continue to push for D&I progress.
In conclusion, the new programs launching to help combat diversity disparities are exciting, whether it’s through TransCelerate, sponsor companies, or other industry consortia. There’s a long road ahead, but if each stakeholder does their part, not only can clinical trials appeal to a wider patient population, but our science and research will better reflect the patient populations most impacted by the diseases being studied – ultimately helping to improve treatment and patient outcomes for underserved communities.
Kathryn (Kate) Owen is Head of Global Clinical Development Operations within Bristol Myers Squibb. In this role, Kate leads and manages all operations related to the conduct of Bristol Myers Squibb clinical trials – clinical pharmacology studies as well as Phase I through IV. She is also responsible for the data management & data standards, including the tools, systems, and processes to support efficient clinical trial execution. The remit of the position includes the oversight of the business systems in support of health economics outcome research (HEOR), investigator-sponsored research (ISR), named patient programs (NPP), and data sharing in relation to marketed products. While Kate’s responsibilities focus on global operational execution, she has a passion for assuring the opportunity & the education of clinical trials is afforded broadly.
Kate joined Bristol Myers Squibb in July 2017 from Novo Nordisk, where she served as Vice President of Clinical Trial Management (CTM) and global sponsor of RBM design & implementation. Prior to this, she spent more than eight years in a range of positions of increasing responsibility at Covance after having started her career in the UK in oncology-focused biotech. Kate received her undergraduate degree from Royal Holloway, University of London in Biology.
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