Presidential Symposium brings patient perspective into focus, explores future directions and challenges for clinical trials domestically and globally

By Jennifer Jang, ASTRO Communications

ASTRO President Jeff Michalski, MD, MBA, FASTRO

The Presidential Symposium offered perspectives for attendees to explore as they considered patients’ roles in clinical trials. ASTRO President Jeff Michalski, MD, MBA, FASTRO, chose this year’s theme to shine a spotlight on patient engagement in advancing research and clinical care.

James Dignam, PhD, moderated Session I on Clinical Trial Design, setting the stage looking at the challenges of trials, including the tension between broad inclusivity versus focused application, rapidity of results versus reliable definite endpoints. Dr. Dignam noted, “prospective clinical trials as yet remain the bedrock of evidence-based medicine, lending the most credible information about effectiveness of interventions.”

Nolan Wages, PhD, spoke on “Novel Designs for Contemporary Early Phase Trials,” including more efficient early phase designs that yield correct dosing, and trials that explore late onset of toxicities. Efficacy without toxicity is the most desirable endpoints.

Matthew Sydes, MSc, CStat, asked “Can We Improve Late Phase Clinical Trials?” He reviewed STAMPEDE, with examples of expedited recruitment, research waste and how to speed up data and reports into practice. The trial has gone on to deliver practice-changing results multiple times.

Eleanor Walker, MD, moderated Session II, Diversity in Clinical Trials, introducing issues surrounding underrepresentation. Lack of diversity poses numerous problems: bias, inability to generalize study findings, safety and efficacy issues, and delays in progress.

Panel participants included Desiree A.H. Walker, patient advocate; Karen Winkfield, MD, PhD, FASTRO; Electra Paskett, PhD; and Brian Rivers, PhD, MPH. They stressed the importance of diversity both within enrolled subjects and the research team.

Other ideas to incorporate including for LGBTQ+, native and rural populations, potentially involve multi-level approaches toward research participation, and options such as novel digital tools, navigators, and resources such as CBOs, faith-based organizations, i.e., sites of trust. Dr. Rivers summarized: “We must dismantle the structural barriers that exist within our health system.”

Bryan Hwang, MD, and Barbara Barclay, Patient Advocate, facilitated the third session as a “fireside chat,” comprised of participant voices from clinical research.

Participants Catherine Circo, Roberta Albany and Joseph Radocchio revealed factors that patients face when deciding to participate. Ms. Albany had her son in mind: “Most of us do want to participate because we understand if we’re not in it, then how can we know if treatments are going to help us save our lives?”

Mr. Radocchio wanted to help push science forward, influenced by learning that certain options like immunotherapy could become part of standard of care.

Themes of building trust continued to emerge. Ms. Albany gave a practical idea of having clinicians wearing buttons saying, “Ask me about clinical trials,” an inexpensive way to encourage asking early on to improve outcomes.

The final session, led by Mitchell Machtay, MD, FASTRO, was comprised of leadership including Quynh-Thu Le, MD, FASTRO, Winette van der Graaf, MD, PhD, Trevor Leong, MD, and May Abdel-Wahab, MD, PhD, FASTRO. Together, they highlighted challenges and opportunities facing multiple international organizations, providing updates from various international societies.

Specifically, Dr. Le provided updates on NRG Oncology (NRG), noting that the goal of the NCTN System is to perform late-stage cancer trials that define the standards of care for the U.S. and the world, and that current aims are to investigate and test novel medical technologies. Dr. van der Graaf provided updates on European Organisation for Research and Treatment of Cancer (EORTC), with the mission of EORTC to improve the quality of life and survival rates of patients, by generating robust medical evidence, setting standards, and acting as a reference for methodological research.

Dr. Leong updated on the Trans-Tasman Radiation Oncology Group Cancer Research (TROG) and stressed that the major challenge is to maintain a diverse portfolio of clinical trials that is available to cancer patients. Dr. Abdel-Wahab of International Atomic Energy Agency (IAEA) shared: “Research policies that lack advance consultation, provide excessive demands, and are overly broad in reach threaten to reverse progress in international collaboration.”

Dr. Michalski closed with summarizing that opportunities are abundant to make trials more efficient and effective. Looking at issues of inclusivity and disparities, concrete suggestions are available on how to engage and advocate for patients to enroll in clinical trials. The refrain emerged repeatedly: build trust and work with patient advocates prior to cancer onset. And cementing those intentions, a big takeaway was the exhortation to clinicians, simply ask. So many are willing to participate if simply asked in the first place.

Registered participants can view this session via the Annual Meeting Portal. Not registered? Purchase the Meeting onDemand.

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