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SWOG outlines decade of work to expand NCI clinical trials in Latin America, cites regulatory and logistics hurdles
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Summary
Dr. Mariana Chavez McGregor told an NCI Global Health seminar that SWOG's Latin America initiative has grown to about 15 active or near‑activation trials, improved accrual and training, but faces persistent barriers—language, regulatory incompatibility and drug/specimen shipping—that limit activation and scale.
Dr. Mariana Chavez McGregor, a breast medical oncologist at The University of Texas MD Anderson Cancer Center and SWOG’s executive officer for international affairs, on Thursday described a decade of progress and persistent hurdles in SWOG’s effort to bring National Cancer Institute–supported clinical trials to Latin America.
"We are increasing the number of protocols available to our Latin American sites, and we’re doing that by identifying those trials that are feasible and that are relevant for Hispanic communities here and there," Chavez McGregor said, summarizing the initiative’s aims to expand trial access and diversify study populations.
The SWOG (formerly the Southwest Oncology Group) Latin America initiative began as a Gates Foundation–funded Helicobacter pylori project and formally launched in 2009 with the National Cancer Institute in Mexico as the first partner, Chavez McGregor said. The effort now works through a small number of vetted sites across several countries—Mexico, Peru, Colombia, Uruguay, Chile and Brazil were cited as past or current partners—rather than treating participation as a single national enrollment.
Chavez McGregor said SWOG’s broader clinical-trial infrastructure includes roughly 1,300 sites and more than 12,000 research staff and patient advocates; SWOG has opened hundreds of trials over decades and has contributed to drug approvals and changes in standards of care. She said SWOG historically recruits more than 4,000 patients a year across its trials, and that 2024 was a particularly strong year for accrual in the Latin America initiative.
Using the trial S1316 as an example, Chavez McGregor described how Latin American participation materially helped enrollment: of about 50 randomized patients in a relevant trial arm, 16 came from Latin America, she said. Those contributions, she added, help answer clinical questions that might be difficult for commercially sponsored studies to address, such as optimization of dosing, cost‑effectiveness, and rare‑disease therapies.
But the presentation stressed operational and regulatory constraints. Chavez McGregor listed key barriers to activation: English-only protocols requiring local translation with no central funding, complex membership and contracting processes, Department of State vetting for some sites, and logistical challenges such as international drug shipment and specimen transport. She warned that country-specific rules can make some partnerships infeasible; in Brazil, she said, national requirements that sponsors cover nearly all components of a trial participant’s care meant SWOG could not support activation under its usual funding model.
"We have learned, for example, of some of our countries that require civil responsibility insurance for those enrolling clinical trials, meaning the sponsor has to pay an insurance that will cover anything that goes wrong," Chavez McGregor said, describing a regulatory mismatch with U.S. trial norms.
To address those problems, SWOG has altered internal processes to make inclusion of Latin America in new protocols the default position early in protocol development, and it has invested in Spanish‑language training for clinical research associates and local investigator workshops. The initiative also publishes a biannual newsletter (first issue 2022) and partners with the Hope Foundation to support early‑stage investigator training in the region.
Chavez McGregor said the initiative now has about 15 trials recruiting or near activation in Latin America, and that the region represented roughly 5% of SWOG patient accrual in 2024. She highlighted efforts to nurture investigator‑initiated concepts from regional investigators but cautioned that funding and committee support remain barriers to converting those ideas into NCTN national trials.
"It takes a long time to get to get here," she said, describing a decade‑long effort to build trust, administrative capacity and bidirectional scientific partnerships.
In the Q&A, Chavez McGregor said SWOG has begun working with other cooperative groups and that vetted SWOG sites with existing Department of State clearance can sometimes act as de facto U.S. sites for network trials. She also confirmed the initiative does not currently operate a jobs board for partner institutions but is open to strategic expansion when sites and SWOG leadership determine a mutual capacity to succeed.
The NCI Center for Global Health webinar recording and related resources are available at cancer.gov/globalhealth and events.cancer.gov/cgh/gcrcss, organizers said. The seminar series is recorded and offers CME credit information for participants.
