April 24, 2023
Irby Hunter, Jr., MD Medical Director Oncology Independent Medical Education Inc & Executive Publisher Oncology Disparities Peer Reviewed Scientific Journal
Disparities across the cancer continuum stem for a long history of institutional and societal injustices that negatively impact the rate of progress in oncology outcomes in diverse populations. Lack of representation among ethnic minorities in research studies about the genetic and microenvironmental changes of tumors has severely limited the understanding of the genetic predispositions that lead to a higher incidence of and mortality rate for cancer in these populations. Long-standing inequities in numerous social determinants of health (SDOH) contribute to significant disparities in the burden of preventable cancer risk factors among socially, economically, and geographically disadvantaged individuals. Routine cancer screening is one of the most effective ways to reduce the burden of cancer, yet, many disparities in screening exist for racial and ethnic minorities and other medically underserved populations. Clinical trials are an important part of medical research because trials establish whether new cancer treatments are safe and effective. Given this knowledge, it is critical for clinical trials to represent all population groups who may need the therapy. However, there is a serious lack of sociodemographic diversity among those patients going onto clinical trials. Many patients from disadvantaged population groups frequently experience severe and multilevel barriers to quality cancer treatment including surgery, radiotherapy, cytotoxic chemotherapy, and molecularly targeted therapy, and immunotherapy. (2)
The 2023 American Association of Cancer Research (AACR) Annual meeting held in Orlanda, Florida from April 14, 2023 to April 19, 2023 proved to be a valuable resource for gaining access to best practices, initiatives, and policies geared toward equipping healthcare providers and research scientists with the tools to solve the national problem of cancer disparities. AACR is home to 54,000 members in over 130 countries and territories. AACR members provide the world with high-quality innovative cancer research. Historically, the AACR Annual Meeting brings together over 22,000 investigators from basic, translational, and clinical disciplines. Multiple AACR conference speakers and attendees shared details about research findings and programs that will result in diminishing the systemic health inequities experienced by racial and ethnic minorities and other medically underserved populations. This manuscript will serve as a chronicle of the AACR Annual Meeting 2023 with respect to cancer disparities as well as diversity, equity, and inclusion (DEI).
During the AACR Annual Meeting 2023 “Opening Session” held on Sunday April 15, 2023 at 8:00 AM EST, AACR Chief Executive Officer (CEO), Margaret Foti and AACR President, Lisa M. Coussens, pointed the general public and cancer research community to the AACR Cancer Disparities Progress Report 2022 Achieving the Bold Vision of Health Equity for Racial and Ethnic Minorities and Other Underserved Populations as the organization’s fundamental response to cancer inequities. Likewise, AACR leadership highlighted the organizations partnership with the National Institute of Health (NIH). Derived from NIH’s Precision Medicine Initiative Working Group, NIH’s All of Us Research Project is working to improve healthcare through research by building a robust resource database including one or more participants reflecting the diversity of the United States (1). Currently NIH has enrolled 100,000 people; 50 percent are from underrepresented groups (2).
As component of the National Cancer Institute (NCI) – NIH sponsored session held on Sunday April 16, 2023 at 11:45 AM EST, Sanya Springfield, Ph.D., Director of the NCI’s Center to Reduce Cancer Health Disparities, led an engaging dialogue about funding opportunities for diversity training and disparities research. NCI’s flagship diversity training program is named Continuing Umbrellas of Research Experiences (CURE). CURE promotes diversity in scientific and clinical research among underrepresented individuals in the biomedical, clinical, behavioral, and social sciences ranges from middle school aged students to post-doctoral fellows. The Support for Research Excellence Program (SuRE) is one of several funding opportunities. SuRE promotes research excellence in institutions that receive limited NIH grants. NCI’s Equity & Inclusion Program (EIP). EIP addresses cancer disparities and increases the diversity in the cancer research workforce. The Early Investigator Advancement Program (EIAP) was highlighted during the session. EIAP fosters an inclusive environment within NCI’s extramural research community, EIAP provides future R01 awardees with mentoring and peer to peer support. Also, The Professional Advancement Virtual Engagement Series (PAVES) is a monthly webinar that provides career development resources to support diverse cancer and cancer health disparity researchers achieve research independence. NCI’s Cancer Moonshot Scholars program advances cancer research while also diversifying the pool of researchers and the approaches to cancer research. (7)
Drs Baras and Mazor, co-chaired a Methods Workshop titled “Utilizing AACR Project GENIE Real-World Clinico-Genomic Data on Saturday April 15, 2023 at 8:00 AM EST. AACR’s Project Genomics Evidence Neoplasia Information Exchange (GENIE) was launched to create a research collaboration with ten biopharmaceutical companies with the goal of obtaining clinical and genomic data from an estimated 50,000 de-identified patients for the purpose of advancing precision oncology (3). To date, Project GENIE® has sequenced tumors from over 121,000 patients; 16,000 are from racial and ethnic minorities (2). Driven by openness, transparency, and inclusion, Project GENIE® is an international open source pancancer registry of real-world data build through data sharing (4). During the annual meeting, AACR announced that four new cancer centers would be joining the consortium: Children’s Hospital Los Angeles, Korea University Anam Hospital, Louisiana State University Health Sciences Center New Orleans, and the University of Miami Sylvester Comprehensive Cancer Center. During the workshop attendees were informed that Project GENIE® was adopted to power precision medicine through real world clinic-genomic data; thereby, making the data set a potential powerful tool to be used to reducing overcome cancer inequities (4).
Cheryl Willman, MD, Executive Director of Mayo Clinic Cancer Program, moderated a Major Symposium held on Saturday April 16, 2023 at 1:00 PM EST. The symposium focused on President Biden’s Cancer Moonshot 2.0. The White House’s Cancer Moonshot 2.0 inspires and supports the next generation of diverse, innovative cancer researchers (7). Additionally, the President’s initiative seeks to increase diversity of cancer research and care workforce to better resemble the communities we serve (7). Dr. Willman addressed the need fully transform decentralized cancer clinical trials bringing trials to people and communities across geographic boundaries using digital and platform innovation, thereby achieving health equity. (8)
The Advances in the Science of Cancer Disparities Major Symposium was held on Sunday April 17, 2023 at 1:00 PM EST. Symposium chair, Lucile L. Adams-Campbell, Ph.D., Associate Director for Minority Health and Health Disparities Research at Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, shared with the audience that Black and African American individuals are at increased risk for overall cancer mortality and poorer health-related quality of life, which may be attributed to earlier age at diagnosis and incidence of more aggressive tumor subtypes. Dr. Adams-Campbell made the correlation between allostatic load at the aforementioned risks. Allostatic load is defined as a measure of cumulative physiological stress and burden across major regulatory systems. Allostatic load is an indicator of adverse health outcomes and can serve as a multidimensional indicator of the body’s response to chronic stressors. She served as the principal investigator for the Focused Intervention on Exercise to Reduce Cancer (FERCE) study. The study demonstrated that physical activity reduces allostatic load in women at increased risk of breast cancer. (9)
A three-part Methods Workshop titled Clinical Trial Design in A Diverse World was co-chaired by Ezra Cohen, MD and Wendy London, PhD. The workshops were held on Saturday, April 15, 2023. Workshop session times were as follows: Part 1 10 AM EST, Part 2 12:30 PM EST, and Part 3 2:00 PM EST.
As a speaker for Part I, Aligning the Needs for a Clinical Trial with the Most Appropriate Design, Dr. Thomas Braun, an expert in the design and application of Bayesian adaptive clinical trials, brought into question the effectiveness of the prevailing Phase 1 clinical trial design type, 3 + 3, as a lead into Phase II clinical trials (5). In addition to highlighting dose expansion cohorts, Dr. Braun recommended several steps to be taken to improve Phase I trials: the need for the use of statistical models, measurement of efficacy outcomes, consideration of more than one dose, tracking patient for more than one cycle, and enrolling a larger number of participants (5). During the same workshop, Elizabeth- Garrett-Mayer, PhD, Vice President of the Center for Research and Analytics at the American Society of Clinical Oncology (ASCO), offered multiple recommendations towards improving Phase II clinical trials: monitoring the evaluability of patients, timing of measurements, paying closer attention to quality-of-life outcomes reporting, and allowing cross-over in randomized trials (5). Dr. Braun and Dr. Garret-Mayer’s collective observations sparks the need for enhanced DEI considerations in Phase I and Phase II clinical trials.
During Part II, Challenges in Clinical Trial Enrollment, Katherine Panageas cited a recently published article authored by Reopell et all. in which the barriers to clinical trial participation were aggregated into four categories: access, racism, workforce diversity, and awareness. Several fundamental solutions were shared with the audience including: transportation vouchers, extending clinic hours, utilization of translators, patient education, employing research ambassadors, cultural competency training, seeking diversity in hiring practices. Katherine Panageas discussed several adopted policies that have been put into place to improve DEI in cancer research. Since 2015, Center for Drug Evaluation Research governed by the Food Drug Administration (FDA) has published Drug Trials Snapshots. Effective April 2022, the FDA released a draft guidance on Diversity Plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials. Effective December 2022, Public law 117-328, requires diversity action plans for phase 3 clinical trial studies. FDA, NCI, and ASCO are formerly recommending broadening eligibility criteria to increase access to trials. FDA is strongly encouraging the incorporation of real-world data to support the design of more representative clinical trials. (6)
Dr. London served as the third speaker for Part III, Biomarkers in Clinical Trials. A biomarker is an objectively measured and evaluated indicator of normal biological processes, pathways, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Diagnostic biomarkers determine the presence of disease. Pharmacodynamic biomarkers assess or monitor the effect of treatment. Prognostic biomarkers are associated with outcomes independent of treatment. Predictive biomarkers are associated with outcomes linked with a specific intervention or treatment. Dr. London instructed the audience to identify sources of bias in biomarker research with respects to age, gender, and ethnicity. She also stressed the importance of DEI consideration resulting in achieving the goal of the specimen collection being representative of the disease population. When using a specimen bank the researchers should calculate proportions by age, race, and ethnicity. (10)
Dr. Lucille Adams-Campbell reminded AACR Annual Meeting 2023 attendees that disparities in cancer screening, diagnostics, outcomes, and care is a problem shared by the entire clinical and research community. The investigators, speakers, and panelists of the 2023 annual meeting are to be commended for lending their research findings, thoughts, and influence towards diminishing cancer related inequities. AACR CEO, Marget Foti, PhD and AACR President, Lisa Coussens PhD are due a great deal of gratitude for keeping cancer disparities at the forefront of the organization’s objectives, operations, and funding. In conclusion, collectively AACR attendees are recommending the immediate adoption of the following best practices and policies in hopes of diminishing cancer inequities:
• widespread usage of diversity plans,
• incorporation of real-world data,
• further investigation of precision therapy,
• accounting for DEI considerations in phase I, phase II, and phase III clinical trial design,
• full optimization of NCI-NIH programs and initiatives,
• address the SDOH associated with cancer risk factors,
• reevaluate clinical trial eligibility, and
• removing bias in biomarker research with respects to age, gender, race, and ethnicity.
References:
- All of Us Research Program. 2023 National Institute of Health All of Us Research Program. Retrieved on April 16, 2023 from All of Us Research Program Overview | All of Us Research Program | NIH
- CancerDisparitiesProgressReport.org [Internet]. Philadelphia: American Association for Cancer Research; ©2022 [cited year month date] Available from http://www.CancerDisparitiesProgressReport.org/.
- AACR Program GENIE: Biopharma Collaborative. AACR American Association for Cancer Research. Retrieved from April 16, 2023 from AACR Project GENIE Biopharma Collaborative (BPC) | AACR
- Baras, Alexandar., Mazor, Tali., Nassar, Amiri. 2023. Utilizing AACR Project Genie Real-World Clinico-Genomic Data. AACR Annual Meeting 2023. AACR. Orlando, Florida. April 15, 2023.
- Cohen, Ezra., London, Wendy., Bruan, Thomas., Garrett-Mayer, Elizabeth. 2023. Clinical Trial Design in a Diverse World, Part 1. Aligning the Needs of a Clinical Trial with the Most Appropriate. AACR Annual Meeting 2023. AACR. Orlando, Florida. April 15, 2023.
- Cohen, Ezra., London, Wendy, Bruan, Thomas., Panageas, Katherine., Martinez, Maria Elena., Hughes-Halbert., Beg Muhammad, Shaalan. 2023. Clinical Trial Design in a Diverse World, Part 2. Challenges in Clinical Trail Enrollment. AACR Annual Meeting 2023. AACR. Orlando, Florida. April 15, 2023.
- Springfield, Sanya., Davani, Behrous., O’Bailey, LeeAnn., Wallace, Tiffany., 2023. NCI-NIH Sponsored Session. 2023. AACR Annual Meeting 2023. AACR. Orlando, Florida. April 15, 2023.
- Willman, Cheryl., Brinker, Nancy., Carnival, Danielle., Nassi, Phyllis., Fairley, Ricki. 2023. President Biden’s Cancer Moonshot Reignited. AACR Annual Meeting 2023. AACR. Orlando, Florida. April 15, 2023.
- Adams-Campbell, Lucile., Lianos, Adana., Ragin, Camille. 2023. Advances in the Science of Cancer Disparities; Disparities and Cancer Outcomes. AACR Annual Meeting 2023. AACR. Orlando. Florida April 15, 2023.
- Cohen, Ezra., London, Wendy., Schalper, Kurt Alex., Yap, Timothy. 2023. Clinical Trial Design in a Diverse World, Part 3, Biomarkers in Clinical Trials. AACR Annual Meeting 2023, AACR. Orlando, Florida April 15, 2023.
