Improving the Patient Journey & Increasing Equitable Access in Oncology Research
by Dr. Shaalan Beg, Vice President of Oncology at Science 37
A 38-year-old mother with stage 4 breast cancer has identified a clinical trial enrolling patients at a site located two-hours away. She depends on her job for insurance and out-of-pocket costs and can’t take many days off work. As a result, she misses appointments and delays treatment until she can find childcare. She grows increasingly tired of handling the logistics and worries about what will happen to her and her family.
Despite being otherwise healthy and interested in participating, she finds that her job, family responsibilities, and location create insurmountable challenges.
Accurate representations of patient populations are critical to produce reliable clinical evidence for patient care, especially when considering well-documented variations1 of more intense side-effects due to race, ethnicity, and/or gender.
Hence when the FDA released clinical trial guidelines2 on data reporting for race, ethnicity, and gender - with calls for less exclusionary enrollment criteria and less patient burden - it was received as a path towards health equity.
These guidelines have garnered support from leading medical professional organizations and oncologists. However, there remains many pervasive challenges complicating the patient journey and hindering more inclusive enrollment of underrepresented populations.
Here are a few known solutions to help improve awareness, access, and equity that are best aligned throughout the patient journey:
Ask ALL patients if they would like to join a clinical trial.
Oncology studies typically enroll 5% of cancer patients3, even though 70% of cancer patients are willing to participate3. Women comprise less than 45%4 of study participants – 73% of whom are white5, while black women have a 12% overall higher mortality rate5. The impact of underrepresenting populations based on race/ethnicity, age, and more cannot be understated:
- Though 1 in 8 women will develop breast cancer, Black women are 41% more likely to die5. Disproportionately, Black, Hispanic, and Indigenous (American Indian/Alaska Native) patients are also more frequently diagnosed with metastatic cancer.
- In comparison to white patients suffering from lung cancer6, Black, Latino, Asian/Pacific Islander, and Indigenous patients are up to 20% less likely to receive early diagnoses, up to 25% more likely not to receive any treatment, and up to 21% less likely to survive for a period of five years.
We must consistently invest time and resources to connect with, educate, and build trust with prospective patients earlier, especially those in underserved communities, by:
- Enhancing digital and social media channel messaging to convey the purpose and methods of clinical trials.
- Holistically engaging all stakeholders (i.e. patients, family members, community leaders, advocacy groups, local providers, site staff, community health workers, etc.) to create greater awareness of current research opportunities and better identify local-level concerns.
- Instituting community advisory councils that can contribute to the development of protocols/study designs, address cultural competencies of study teams, and include linguistically and culturally appropriate recruitment and optimized consent documents that support equitable patient participation.
Address the disruptive financial, geographic, and logistical challenges of daily life.
Cancer patients with household incomes below $50,000 are 27% less likely7 to participate in clinical trials, despite representing 29% of the U.S. population and being the most diverse income group.
Furthermore, because 98% of cancer trials take place at academic medical centers8, recruitment is highly dependent on the local populations and pre-existing referral networks.
The following steps can help overcome logistical barriers to trial participation:
- Investment in infrastructure that empowers community health centers, rural health centers, and safety net hospitals to act as central hubs for clinical studies. These trusted neighborhood staples often have limited access to research opportunities but serve diverse communities.
- Innovate trial delivery in oncology with more seamless, universal, decentralized technologies. Newer treatments (i.e. immunotherapies) don’t have the same toxicity profiles as traditional chemotherapy; technology can therefore work in conjunction with networks of telemedicine investigators, remote coordinators, and mobile nurses to provide robust oversight, collection of high-quality data, and end-to-end trial management in real-time.
- Enhance our methodologies to allow patient centricity and empower patients to choose whether study visits can take place at-home or on-site at hospitals, clinics, or laboratories within their own communities, when feasible and safe. This shift could improve study retention and is often preferred by patients with debilitating symptoms.
Recognize how population sample bias undermines the validity of clinical trials and breeds patient mistrust.
One study shows that women with cancer are initially misdiagnosed with stress and anxiety9, while another shows only one-third of eligible Black patients reported receiving any information on cancer clinical trials10. This is despite the fact that fewer women (28%) participate in clinical studies for colorectal cancer11 than would be expected based on the proportion of U.S. women with the disease, while Black Americans have a 20% higher incidence12 and overall likelihood of developing the disease at a younger age.
This is a complex challenge that cannot be solved by changes to clinical trials alone. However, because a doctor’s race has been reported to play a major role in whether patients decide to participate in a clinical trial, we can and should:
- Involve local physicians and oncologists whom patients trust into studies as sub-investigators so as to not disrupt those relationships.
- Utilize infrastructure already in place to involve providers while decentralizing study procedures such as consent, education, and training. This can optimize and accelerate the development of new treatments without excessive burden to sites.
Most patients will never be able to participate in trials testing innovative treatments, screening methods, or preventative therapies if their doctors never present them as opportunities.
In one study among Latinx and Black residents of both rural and urban areas, 75% were willing to participate in clinical research, but over 90% had never been asked8.
Only a patient with cancer fully understands the challenges and obstacles they will face when participating in a clinical trial – and, especially given the more efficient and agile future of oncological trials, assumptions regarding one’s ability to participate must never be a factor.
Therefore, to pursue more equitable and representative oncological care, we must consider at the start of every clinical study how decentralizing aspects can change lives while decreasing patient burden, increasing enrollment, improving retention, and expanding diversity.