September is National Awareness Month for Prostate, Childhood, Ovarian, Blood and Thyroid Cancers, which often hit underserved populations the hardest. Reasons why include: they reside in under-resourced communities that are medical deserts; they may experience physician and PI bias; they may have a long-standing fear of the ‘white coats’; or they do not know what to do when they have indicators. Consequently, there is a lack of early detection, a lack of early-stage clinical care, significantly lower participation in cancer clinical trials, and worse health outcomes. When compounded with prejudice and systemic discrimination, underserved populations don’t always experience a healthcare system, they can experience a hell-care system.
There are many factors that contribute to underrepresentation of underserved populations in clinical trials at both the sponsor and site level. With the commitment of anti-racist practices across the life sciences industry, I want to take a look inward and focus on three areas that we seldomly discuss: 1) bias during the clinical trial process; 2) sponsor bias; and 3) publication/citation bias. As an industry, what can we do to eradicate these biases to increase more clinical trial participation with diverse, marginalized, or under-resourced populations? Let’s examine all three because you must understand a problem before you can solve it. And a better understanding of these biases and how it affects study results is essential to eradication.
Bias during the clinical trial process – Bias can occur in the planning, data collection, analysis, and publication phases of research. According to a recent American Cancer Society (ACS) study, the first of its kind, researchers conducted a series of 91 qualitative interviews at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. According to researchers, bias can take three forms: prejudice (negative attitudes), stereotypes (categorical beliefs), and discrimination (unequal treatment). Some of the themes include:
- Interactions with potential minority participants were perceived to be challenging
- Potential minority participants are not perceived to be ideal study candidates
- A combination of clinic-based barriers and negative perceptions of minority study participants leads to providers withholding clinical trial opportunities from potential minority participants
Sponsorship bias – This refers to the influence of commercial interests who have a vested stake in the outcomes of their trial. The biopharma industry is primarily responsible for testing their products, which some may view as a conflict of interest. Some have recommended that a firewall needs to be in place between the funders and the people doing the research as well as data analysis. Another recommendation is to develop an entirely separate funding source for clinical trials that is independent of the biopharma industry. Would these ideas help remove this bias? Or would they impede the very research we as an industry want to accelerate?
Citation bias – This refers to the fact that researchers and trial sponsors may be unwilling to publish unfavorable results, believing that such findings may negatively reflect on their personal abilities or on the efficacy of their product. For example, multiple outcomes are measured but only the significant outcomes are reported, while insignificant or unfavorable outcomes are ignored. So, how do you balance help and potential harm? How can we factor in more transparency and oversight to the benefit of all?
Clinical trials are the cornerstone of biopharma’s commitment to developing safe and effective therapies. Yet, we know the current system is not perfect. As we continue to address ED&I throughout our industry, our aim must be always on how what we’re doing impacts the patient. COVID-19 has shown clearly that many systems need fixing and clinical trials is one place where improvements, specifically reducing biases, can lead to immediate improvements in patient outcomes in diverse populations.
To learn more about access to cancer care and the patient’s current path to diagnosis and treatment, register to attend our October 1st event, “Access To Care Challenges And Innovation During Covid-19: An Oncology Perspective.”