By Peter J. O’Dwyer, MD (left)
and Mitchell D. Schnall, MD, PhD

Older adults make up a large proportion of people diagnosed with cancer, yet they remain consistently underrepresented in clinical trials. A recent publication by Dr. Laurie Pearson and colleagues (including Dr. Efrat Dotan, chair of our Geriatric Oncology Committee) highlights where gaps persist. The analysis examined older adult enrollment in landmark ECOG-ACRIN clinical trials conducted between 2005 and 2019 and found substantial underrepresentation compared with the real-world cancer population. Although older adults account for roughly half of US cancer diagnoses, they comprised just 26% of trial participants, with enrollment declining sharply with advancing age. Trials with restrictive eligibility criteria enrolled younger populations, while community sites enrolled a higher proportion of older adults than academic centers. The findings highlight ongoing structural and design-related barriers and underscore the need for strategies to improve trial inclusivity for older adults.

Under the leadership of Dr. Dotan, the Geriatric Oncology Committee has activated three trials to date to explore the effectiveness of treatment strategies in elderly patients with various cancers, and to promote the use of objective geriatric assessment tools to guide therapeutic decision-making. The Committee has a number of additional projects underway, including imaging analyses and biomarker and correlative studies.

In the fall, an editorial appeared in Science that was intriguing to us, but was displaced by other issues until now. The authors (a former CEO of the American Association for the Advancement of Science and a current senior program officer at the National Academies) recognize the stresses and funding insecurities of the current environment but point out that “regulatory and policy requirements force researchers to spend nearly half of their research time on paperwork… not on discovery.”  They propose that the current political focus on efficiency offers an opportunity to reform federal regulations to decrease burdensome and often duplicative tasks associated with grant- and contract-supported research. They also point out that our institutions themselves contribute significantly to this burden.

Though not a focus of the Science editorial, the preceding statements must resonate particularly with those of us engaged in clinical research. We see examples at all levels of our activity, including:

• Annual conflict of interest documentation (for multiple interrogators, including journals!)
• Irrelevant or repetitive “training”
• Nitpicking Institutional Review Board review, and
• Consent forms that seem constructed more to protect institutions from liability than to be truly informational to the patient

We are distracted from our “real work” by redundant or meaningless tasks. In September, the National Academies produced a report, “Simplifying Research Regulations and Policies: Optimizing American Science.” This timely publication provides three recommendations that can span the research landscape: harmonize regulations and reporting requirements across agencies; adjust the intensity of regulation to the risk to individuals or society; and use technology to simplify compliance. Though addressed only tangentially in the report, the recommendations are pertinent to clinical research as much as basic science and should be a focus of our attention in facilitating research. The issues are thorny; if there is interest, we will convene a working group to explore further.

Even as we navigate regulatory complexity, our core mission moves forward. An exciting trial for patients with extensive-stage small cell lung cancer (SCLC) is now open through PrECOG. PrE0510 is a phase 2 study designed to determine the optimal dose of ivonescimab in combination with carboplatin and etoposide chemotherapy. Ivonescimab is a novel bispecific antibody designed to simultaneously target PD-1 and VEGF. PrECOG is open to adding additional sites, so please email the study team if you are interested.

Read the February 2026 issue here.