The pharmaceutical industry has evolved significantly in the past few decades to better meet the needs of today’s patients. Since I left my medical practice to join the industry 15 years ago, the role of Medical Affairs has changed significantly with this evolution. It has moved from a function primarily supporting recruitment in Research and Development (R&D) clinical trials and educating the data that these trials produce, to a function that is integrated along all phases of drug development and commercialization. As we continue in this expanded capacity, we also have an opportunity to become even better advocates for diversity across clinical trials, continue to advance our knowledge of treatments and deliver innovation where it is needed.
Barriers to clinical trial participation and consequences
The National Institutes of Health (NIH) Revitalization Act of 1993 established guidelines for inclusion of women and underrepresented racial and ethnic groups in NIH-funded clinical research. Unfortunately, two decades later there has been little improvement in participation by several of these groups, including Blacks, Hispanics, Native Americans, Asian Americans and Pacific Islanders in clinical trials. While these groups comprise approximately 40% of the US population, they represented only 25% of clinical trial participants in the trials of the 53 medicines approved by the US Food and Drug Administration (FDA) in 2020. Moreover, according to a recent analysis of nearly 100 precision oncology trials in the US, White participants were overrepresented by 35% while Black and Hispanic participants were underrepresented by nearly 50% and 75%, respectively, when compared to the expected number of cancer cases based on the corresponding population.
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To close the gap in clinical trial diversity, it is critical to recognize that underrepresented populations face both structural and personal barriers to clinical trial access and participation. Structural barriers restrict a person’s ability to participate; these include proximity to trial sites, transportation challenges and language barriers between patient and trial personnel. Personal barriers include distrust in the research process, lack of clinical trial awareness, and unconscious bias among clinicians and site investigators. All these factors limit clinical trial enrollment.
Capturing the heterogeneity of the patient community in clinical research is necessary to provide truly representative data when bringing safe and effective treatments to the larger population. Improving diversity of and access to clinical trials is critical to the success of trials and important in building the confidence in underrepresented patient populations. This is especially consequential in oncology where patients may respond differently to medical therapies based on their ethnic, racial and family history.
Medical Affairs’ role in breaking down barriers
As a critical function in dissemination of scientific data and stakeholder engagement across a medicine’s lifecycle, Medical Affairs has a role in addressing the structural and personal barriers to clinical trial diversity alongside the functions of R&D, Commercial and Market Access. These approaches can include the use of new technologies, changing the way we conduct clinical trials and gather patient data, and more direct approaches that provide clinical trial participants with education, information and support throughout their journey.
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- Patient-centric planning and implementation to address structural barriers
A key approach to addressing structural barriers is implementing a patient-centric approach early in the medical planning process. This includes broadening trial inclusion criteria, simplifying study designs and randomization, and establishing trial sites where patients live, not just large clinical centers. It also includes accounting for the individual patient’s circumstances (e.g., providing transportation support, childcare and family support where needed), and communicating the trial information in languages most accessible to the patient.
By tapping into advanced analytics and cross-functional digital execution, Medical Affairs is uniquely positioned to understand where the relevant patient populations are located across the US, while leveraging this information with our R&D colleagues to expand our clinical trial footprint. In addition, we leverage data to streamline the clinical trial experience for patients across various geographies by providing remote data collection, at-home health monitoring devices, and online tools for informed consent and information about clinical trials. Finally, we deploy tactical solutions such as partnering with ride share services, providing transportation for patients who are enrolled but don’t live near the trial site.
- Accelerating change through collaborations to address personal barriers
Another challenge in clinical trial access and participation is that the pharmaceutical industry is not perceived the same across different cultural groups, which can be attributed to longstanding institutional and implicit bias in medicine and restrictions on equitable access to clinical services. This lack of trust can often lead to self-exclusion from clinical trials. Therefore, there is an urgent need to build trust by engaging local organizations to reach underrepresented communities.
With an increasingly large and complex healthcare system, collaborations with a range of stakeholders are critical. This includes medical societies, payers and patient advocacy groups. Collaborations are at the heart of any successful approach to health equity and can increase trial participation among populations that have been historically underrepresented, in turn increasing participation across the continuum of care, including early screening and treatment adherence.
Underrepresentation of racial and ethnic groups and other historically disenfranchised populations in clinical trials continues to be a major public health challenge. Medical Affairs can help identify solutions as we constantly gather insights from different stakeholders and can drive collaborations that can lead to a change in the current status quo. The benefits of inclusive trials extend beyond the clinical scenario to include participation of marginalized communities in healthcare more broadly, advancing the understanding of the disease area as a whole and ultimately, helping improve cancer treatment for all impacted by the disease.
As the Vice President and Head of Medical Affairs for US Oncology Business Unit, Carlos Doti, MD, leads the teams responsible for the development and delivery of the medical strategy across AstraZeneca’s US oncology portfolio. Since joining AstraZeneca in 2016, he has held various Medical Affairs leadership roles within the Oncology Business Unit within the International markets and on a Global level. Most recently, he served as the Global Medical Franchise Head of Hematology where he led the delivery of integrated confidence and evidence generation plans, while implementing new development initiatives.
Prior to joining AstraZeneca, he was with Pfizer and Novo Nordisk where he served in various leadership roles in Latin America Medical Affairs. He received his MD from the University of Buenos Aires, where he specialized in hematology. As a practicing physician, he specialized in hematology and bone marrow transplant.
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