Fostering Inclusivity in Clinical Trials: A Vital Step Towards True Innovation for All
In the ever-evolving landscape of life sciences and healthcare, the quest for groundbreaking therapies and medical advancements stands as a shared mission. Innovators strive toward that goal and patients advocate for the results. As a life science lawyer with over two decades of experience in the industry, my unwavering commitment has been to facilitate the journey of innovative therapies from discovery in laboratories to patients in need. In this pursuit, one indispensable factor often overlooked is the crucial role of diversity in clinical trials.
Diversity in clinical trials is not merely a catchphrase; it’s a cornerstone that can unlock the true potential of innovation. Inclusivity in the study of new innovations leads to inclusivity in the use and real life application of the approved product. While the life sciences industry has made remarkable strides in recent years, embracing diversity in clinical research remains an essential, yet often underemphasized, component in the development process.
Why is Diversity in Clinical Trials So Important?
- Scientific Rigor and Validity:
Clinical trials serve as the backbone of drug and device development. They provide essential data on a treatment or intervention’s safety and efficacy, which forms the basis for regulatory approvals, in jurisdictions all around the world. However, for these trials to be truly applicable to real-world scenarios, they must reflect the rich tapestry of our diverse society. Too often the sanitized version of randomized, controlled studies simply do not hold true in the broader population post-approval.
- Ethical Imperative:
Diversity is not just a scientific necessity; it’s an ethical imperative. As life science professionals, we must ensure that our therapies are accessible and effective for everyone, irrespective of their race, ethnicity, gender, or socioeconomic status. Addressing healthcare disparities in treatment and access can begin with diverse clinical trial participation.
- Market Access and Commercial Viability:
Beyond ethics and science, diversity has economic implications for the innovators and the patients who will benefit from the approved treatments. Diverse patient populations represent potential future markets. When therapies are tested and proven effective for a broad spectrum of patients, they stand a better chance of gaining a comparably broad market access and achieving commercial success. Many durg innovators understand this and are embracing diversity in clinical trials as an imperative to successfully bringing effective drugs to a broader group of patients. (See https://www.ciscrp.org/why-diversity-in-clinical-trials-matters/).
Challenges to Achieving MEANINGFUL Diversity in Trials
While the need for diversity in clinical trials is becoming more clear with each passing day, achieving it is not without significant challenges that must be overcome:
- Historical Distrust:
Many minority communities have a deep-seated distrust of the medical establishment due to real and proven historical injustices. Building trust takes time and concerted efforts. - Cultural and Linguistic Barriers:
Language and cultural differences can impede recruitment efforts. Providing culturally sensitive materials and interpreters is essential but may not always suffice. - Socioeconomic Disparities:
Socioeconomic factors can affect participation in clinical trials. For example, individuals with lower incomes may struggle to cover transportation or childcare costs, even with compensation. Surveyed trial participants often cite fear of losing health insurance coverage as one of the factors for not participating in clinical research, whether that fear is true is irrelevant if the financial fear alone results in non-participation. - Regulatory and Ethical Considerations:
Navigating ethical and regulatory issues, particularly regarding informed consent and data privacy, can be challenging when striving for diversity. Establishing inclusion/exclusion criteria in the study design that will acheive diversity goals without impacting the statistical analysis that measures success of the investigational product is a real and perhaps insurmountable challenge. - Logistical Complexities:
Coordinating recruitment strategies, especially in underserved areas, can be logistically complex. Outreach events, transportation, and access to study sites require careful planning.
THE WAY FORWARD: Actionable Tactics to Achieve Meaningful Clinical Trial Diversity
Solving these complex challenges does not come wrapped neatly in a single solution. We must use multi-faceted and multi-disciplinary tools to attack the problem if the goal of broad inclusion is really to be realized.
- Community Engagement and Trust-Building: Actively engage with diverse communities to build trust and awareness about the importance of clinical trials.
- Cultural Competence: Ensure that clinical trial staff are culturally competent and sensitive to the needs of diverse participants. Clearly the role of community health workers is an essential link to effectively acheiving this goal. FQHCs (Federally Qualified Health Centers) are an untapped source of expertise and access in underserved communites that are often left out of clinical trial opportunities.
- Improve Recruitment Strategies: Develop targeted recruitment strategies, collaborate with healthcare providers, and leverage patient registries. But these strategies need to be done in conjunction with, not independent of, effective communication, cultural competence and correctly aligned incentives. Clinical trial teams need to reflect the inclusive mission. We need more diverse investigators that understand the value study participation has -immediately for the patient in gaining access to valuable health care within the study and also long term in attaining a broadly applicable safe and effective product in the approval. (See Perspectives from Principal Investigators on Improving Diversity Among Clinical Research Participants: https://acrpnet.org/2023/08/perspectives-from-principal-investigators-on-improving-diversity-among-clinical-research-participants/).
- Clinical research is a care option. Yes, there are risks and benefits in clinical research. But research is showing that outcomes of clinical trial participants improve exponentially, and not necessarily in the area under investigation, but more broadly, because they are being cared for by a more robust and holistic health team within the clinical study. Incentives need to be aligned to make this a reality.
- Patient Focus: We should start calling study participants “patients” and not referring to them as “subjects”. The language we use matters. Patients benefit from the study (even though there are risks, all studies are calibrated to ensure that the benefits outweight the risks even before the study begins) and then more patients benefit from approved and widely available products. This video, from the Hawthorne Effect, is a wonderful reminder of how patient focus, patient centricity and patient impact should be at the center of all aspects of innovation. https://www.linkedin.com/posts/hawthorneeffect_the-immediate-impact-of-clinical-trials-activity-7064248823669293056-YFGh?utm_source=share&utm_medium=member_desktop
As a life science innovator myself (in my own way!), my mission has always been to facilitate the development and delivery of innovative therapies to those in need. To realize this mission fully, the life sciences industry must embrace diversity in clinical trials as a fundamental and non-negotiable element of drug development.
We are at a crossroads where science, ethics, and economics converge. The path forward is clear: we must actively work to remove barriers, foster inclusivity, and ensure that the innovative fruits of our labor are accessible and effective for all. In doing so, we can truly unlock the potential of innovative therapies and bring hope to patients from every corner of our diverse world.
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