Ivy Riano, MD, discusses the adoption of broader clinical trial eligibility in lung cancer, specifically for those with brain metastases or leptomeningeal disease.

Broader Clinical Trial Eligibility in Lung Cancer

Ivy Riano, MD, of Dartmouth Geisel School of Medicine, discusses the adoption of broader clinical trial eligibility in lung cancer, specifically for those with brain metastases or leptomeningeal disease.

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Ivy Riano, MD, of Dartmouth Geisel School of Medicine, discusses the adoption of broader clinical trial eligibility in lung cancer, specifically for those with brain metastases or leptomeningeal disease. 

Adopting Broader Clinical Trial Eligibility in Lung Cancer With Brain Mets, Leptomeningeal Disease

Over the years, clinical trials have been the strongest means of advancing cancer research and treatments. Clinical trials are pivotal to developing novel therapeutics to enhance the anticancer drug arsenal. Most patients with cancer do not participate in clinical trials, even though nearly three-fourths of Americans are said to be interested in or willing to enroll in clinical trials.

 This discrepancy is partially explained by clinicians’ unawareness of opportunities to enroll patients in ongoing clinical studies. Moreover, many early-career clinicians are not familiarized with clinical trials during their training, given that this is not part of their hematology-oncology fellowship. Thus, the opportunity to educate future trialists is hindered.

Not surprisingly, these barriers are heightened for patients and clinicians from underserved racial or ethnic populations, low educational and socioeconomic levels, and/or those residing in rural areas. Many strategies to tackle these obstacles have been widely discussed in the literature; however, policies formally incorporated into graduate medical education curricula are missing. Increasing awareness is often recommended through education during fellowship programs; however, across the US, just a few institutions have properly included clinical trial training to prepare future oncology trialists.

 Moreover, why these recommendations have not been adopted nationwide is unclear. Although not all clinicians will become trialists, it is important that they are aware of clinical trial opportunities to expand recruitment, contribute to research with fairness, and promote engagement.

Other strategies at the provider level aim to promote clinical trial enrollment during patient-physician encounters. However, engagement will likely decrease if the programs provide no formal training. Desirable features in clinical trial curricula train clinicians in a multidisciplinary environment where communication specialists, experienced trialists, clinical research coordinators, and mid-career/senior oncologists are actively involved.

Moreover, efforts should be focused on providing additional resources and maintaining engagement in underrepresented populations. These populations are more likely to have higher dropout rates, which can affect equity in clinical trial enrollment.

An anticipated outcome of early-career clinicians receiving education and training in clinical trials is that they will likely develop research skills centered on the patient. Moreover, when clinicians offer to enroll patients in clinical trials, this increases access to novel treatments with the promise of safer and/or higher effectiveness compared with the standard of care; thus, patients receiving novel therapies or treatment modalities may have access to potentially lifesaving therapies or increasing their quality of life, which are pillars in cancer care. The earlier an oncology fellow receives appropriate training, the more efficiently they will be able to manage patient recruitment, consent, and ethical considerations, which will ultimately enhance patient care, and advance clinical research in their institutions or centers. Ethical and science advisory boards are also more likely to benefit from medical discussions under ethical principles, ensuring clinical research is conducted with the highest standards and integrity.

Another advantage of educating clinicians early in their careers is to aid in identifying and promoting equity in accessibility to clinical trials. Inclusiveness can be promoted if clinicians know about a patient’s disparities. Thus, by acknowledging barriers such as fear of adverse effects, the clinician can become an advocate and ally to increase accessibility with fairness and justice. In subsequent patient encounters, these interactions are likely to strengthen the patient-physician relationship, with valuable results for clinical care and research.

Overall, a comprehensive education curriculum during hematology and oncology fellowship for clinical trials will yield individual and societal benefits by advancing cancer treatment, improving patient-relevant outcomes, and enhancing cancer research.

Ivy Riano, MD, is a thoracic oncologist and an assistant professor of medicine at Dartmouth Cancer Center, Dartmouth Hitchcock Medical Center, and Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. 

. 2016;35:185-198. doi:10.1200/EDBK_156686

Mara AA, Rader R, Bylund C, et al. QIM23-139: Creating a fellowship curriculum: clinical trial patient conversations. 

. 2023;21(3.5):QIM23-139. doi:10.6004/jnccn.2022.7195

Murphy MC, Parker ND, Amin TB, et al. Educating hematology-oncology fellows about how to communicate with patients about cancer clinical trials: a needs assessment. 

. 2024;42(suppl 16):9029. doi:10.1200/ JCO.2024.42.16_suppl.9029

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Many early-career clinicians are not familiarized with clinical trials during their training, so the opportunity to educate future trialists is hindered.

Ivy Riano, MD

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Adopting Broader Clinical Trial Eligibility in Lung Cancer With Brain Mets, Leptomeningeal Disease

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