ASCO 2023 preview: Prioritising the exploration of patient differences to enhance cancer care and research
The American Society of Clinical Oncology (ASCO) annual meeting is approaching and provides the ideal setting to connect with friends and colleagues in the global cancer care community. The key theme of this year’s meeting, Partnering with Patients: The Cornerstone of Cancer Care and Research, reinforces that we are in the fight against cancer alongside the patients we aim to serve. We are pleased this year’s meeting emphasises the value that comes from increasing our focus on the perspective that patients bring to oncology drug development, giving us the chance to gain insights from those who participate in critical oncology trials.
Anticipating what we may hear in next week’s conversations, we know there will be a running focus on tangible ways the industry can act to keep the patient front and centre in drug development, including the following critical topics in cancer care optimisation.
Reaching traditionally underserved patients
Among the many ways to enhance patient centricity, perhaps our greatest opportunity is to increase racial and ethnic diversity in oncology clinical trials. This inequity was particularly spotlighted during the COVID-19 pandemic. In response, our industry has recommitted to breaking down long-standing barriers to participation among traditionally underserved patient communities.
Recognising long-standing barriers
Though there is much headway yet to be made, the industry recognises that there are multiple patient-specific roadblocks to trial participation among underserved populations, including:
- Mistrust or fear of the clinical trial process, driven by historical discrimination or marginalising practices towards minorities. This can be compounded by discomfort with the communication style of the investigator or site or by outreach that is not culturally tailored to resonate with a diverse population.
- Lack of clinical trial awareness, which is further impacted by limited access to health care, particularly to institutions with robust clinical research programmes that could increase patients’ understanding of the value of trial participation.
- Cultural barriers to participation, especially regarding communication. Patient discomfort with the language format or one’s literacy level may present a challenge, even with effective translation services for written documents. Engaging family and community leaders when presenting the trial is an important aspect in many cultures and should be considered.
- Investigators and providers may have a conscious or unconscious bias towards engagement of minorities in trials, based on their understanding of the patient’s ability to comply with all aspects of participation. In today’s complex healthcare environment, a provider’s attitude toward the additional work required for a patient in a clinical trial may discourage participation.
- Financial and logistical challenges associated with trial participation can discourage patients. Often minorities represent lower socio-economic populations with limited resources to deal with the financial burdens of study participation (e.g., travel to trial site, meals, time off from work, childcare, added medical costs not covered by insurance, etc.).
Tangible steps towards progress
Findings from a retrospective analysis evaluating patient diversity in 113 pivotal immunotherapy studies of FDA-approved therapies published in Nature Review Drug Discovery last year found that African American patients were largely underrepresented (2% of total patients) in the indications that secured the most immuno-oncology (IO) approvals. In surveying more than 60 oncology clinical trial professionals in the analysis, the greatest barriers to diverse enrolment included the lack of involvement of community-based sites and distance to existing study sites, as well as indirect cost of participation (e.g., travel, child support, and missing work). Respondents noted the most impactful strategy to improve trial diversity was offering financial support systems that go beyond what is currently available through the Clinical Treatment Act and via Medicaid for low-income individuals, including compensation for missed work days or financial aid for childcare.
From the sponsor perspective, working with providers to ensure research opportunities are discussed with patients during visits and bettering engagement with minority-serving community centres are two critical pieces to the puzzle. As researchers, recruiting a trial population to evaluate a treatment effect may lead one towards use of sites with a proven track record for enrolment and collection of high-quality data. Given the factors noted above, it can be difficult for any company, particularly for emerging biopharma, to look beyond those centres that have well-established research programmes, but may not be noted for the diversity of the population which they serve.
From a regulatory perspective, the US Food and Drug Administration (FDA) is taking actionable steps to ensure trial enrolment reflects the population who will ultimately use the treatment. Upholding its 2022 draft guidance, the agency has issued complete response letters to several sponsors, requesting better reflection of the US patient population in studies after receiving submissions of patient data from single country studies. Also, understanding that exclusion criteria disproportionately affect some patient groups (e.g., African Americans) due to higher comorbidity prevalence, the FDA’s guidance provides sponsor recommendations for widening and updating trial eligibility criteria.
We are seeing how crucial it is to be deliberately focused on diversity goals during trial design and planning. Quantitatively calculating patient burden using qualitative patient insights about trial design influencers can help improve participation. Sponsors and their clinical research organisation partners can ask key questions earlier on, including:
- What factors will motivate participation by a more diverse population of patients?
- Do those influences vary by race and ethnicity? If yes, which protocol design elements impact interest in participation and by how much?
For example, for those eligible to receive certain immunotherapies, knowing if the patient and their family are willing to participate in a trial requiring a significant time commitment (e.g., with infusions once every few weeks over a year or longer, or inpatient stays required) sheds light on protocol burden and how to better account for diverse patient population needs.
We look forward to having an open dialogue with colleagues this week on key learnings and best practices to make a long-term impact.
Further personalising medicine
Continuing a key conversation from ASCO 2022, our community seeks to evaluate oncology care paradigms to effectively shift from treating overarching disease characteristics to treating disease based on patient profiles. Currently, the focus is on enhancing innovative therapies to meet the needs of patients based on genetics, environment, and lifestyle. Doing so requires effective strategies to improve trial diversity among underserved populations to truly gauge how these treatments may provide real-world benefits to those most impacted by certain cancers. Our industry is highly aware of this concern and is taking steps to better address it in trial design and operations.
Immunotherapy has changed the outlook for many patients impacted by cancer. However, to maximise this promising therapy’s benefits, striving for better response rates and greater accessibility to this care is key. We are interested to see what takeaways will come from discussions at ASCO about examining how life-changing immunotherapies can be used solely or in combination to be more effective for patients based on racial and ethnic differences. For example, there will be conversations around the use of next-generation sequencing testing for patients with advanced non-small cell lung cancer (NSCLC) to better understand genetic variations and biomarker insights that help with cancer predisposition, diagnosis, and related treatment plans. Leveraging NGS-driven insights can help drive more individualised therapeutics for varying patient populations.
Making progress through collaboration
As we connect with colleagues at ASCO, most will agree that to be successful in the fight against cancer globally, we need to break down our information silos, sharing our knowledge and learnings to best meet the evolving needs of patients with cancer.
Oncology drug development will always be a complicated space, requiring multi-pronged strategies, evolving expertise, and innovative solutions to make a genuine impact in patients’ lives. We are excited to come together and engage in meaningful conversations with key stakeholders actively involved in improving patient outcomes. As we further explore the latest advancements in cancer care at ASCO next week, we know this stage will represent another critical step in the overall efforts of the community to drive cancer care forward.
About the authors
James Kyle Bryan, MD, chief medical officer, IQVIA Biotech
As CMO, Bryan is responsible for strategic global medical and scientific leadership for IQVIA Biotech, collaborating across the IQVIA organisation to advance the development programmes. Focused on drug discovery and development in the biotechnology and pharmaceutical industries for more than 25 years, and board-certified in haematology and medical oncology, Bryan also remains actively engaged in clinical care as a clinical faculty member at the University of Washington Medical Center, allowing him to better understand the current needs and wants of patients to factor into his guidance for trial sponsors.
Dr Sari Heitner Enschede, senior medical director and haematology-medical strategy lead, Oncology Center of Excellence, IQVIA
Dr Enschede has worked in the pharmaceutical industry for 18 years with five years at IQVIA, providing strategic guidance to customers for haematology studies and programmes, and consultation and leveraging of professional networks for haematology-specific partnerships. Her previous experience at AbbVie/Abbott entailed leading global clinical trials in haematologic malignancies for Phases 1-4, with key roles in product safety, regulatory agency communications, and the launch of its BCL2 inhibitor Venetoclax. Prior to transitioning into the pharmaceutical industry, Dr Enschede was an experienced haematologist who served as assistant professor in medicine in the Department of Hematology-Oncology at Rush University in Chicago.
Forrest H. Anthony, MD, PhD, senior medical director, Oncology Center of Excellence, IQVIA
With more than 25 years of pharmaceutical and biotech leadership experience and 15 years of diverse oncology trial management, Anthony currently focuses on early engagement guidance for emerging oncology trial sponsors, as well as serving as a medical advisor for ongoing oncology trials. He helps ensure the team is thoroughly trained on the latest immune-oncology product trials and plays a key role in forecasting oncology-specific technology trends to guide strategic planning for customers. Anthony previously served as president of the Association of Biotechnology Companies and as a founding board member of the Biotechnology Innovation Organization.