Expanding Clinical Trial Access and Individualizing Care: Vicki Keedy, MD

Clinical trials play an outsized role in rare cancers such as sarcoma, where many subtypes fail to respond to standard therapies and oncologists often reach for investigational options early, according to Vicki Keedy, MD, MSCI, clinical director of the Sarcoma Program at Vanderbilt-Ingram Cancer Center.

Why Trial Access Is the Central Barrier

The greatest obstacle, Keedy explains, is simply reaching a trial. Because sarcoma is rare, research funding is limited, and the sites running any given study are often scattered across the country. Patients in rural areas may drive hours just to reach an airport before traveling on to a participating center. Trials backed by foundations or grants, rather than well-resourced pharmaceutical sponsors, may open at only 3 to 5 sites nationwide, leaving patients to shoulder substantial travel and financial burdens. Keedy notes that insurance network rules compound the problem, as some Medicaid programs will not cover out-of-state travel, and patients without a sarcoma center in their state can struggle to access expert care at all. Expanding the number of trial sites and enlisting foundations to offset travel costs, she argues, would meaningfully widen access.

She also pushes back on a persistent assumption that rare disease trials cannot enroll. The "if we build it, they will come" mentality, whereby trials are open in only a handful of sites on the belief that desperate patients will travel anywhere, overlooks the reality that many lack the time, money, and family support to do so. 

How Care Has Shifted Toward Shared Decisions

Keedy highlights desmoid tumors (DTs) as a case where management has changed dramatically over 20 years, moving away from repeated, often morbid surgeries. She credits patient advocacy groups with rerouting patients to specialty centers and away from unnecessary operations performed by surgeons who may not have treated a DT in decades.

With a growing menu of therapies and no head-to-head trial data, treatment becomes highly individualized. Keedy explains the shared decision-making process where physicians assess whether to observe, since some DTs regress on their own, how quickly a symptomatic patient needs a response and whether a patient prefers daily oral therapy of uncertain duration or a defined course of intravenous chemotherapy. Adverse effects, fertility and pregnancy concerns, out-of-pocket drug costs, and lifestyle factors, including whether telehealth and local labs can support pill-based care, all shape the final choice.