> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Reforms Needed to Boost Efficiency of Global Cancer Trials: Report
- URL: https://www.fdaweb.com/reforms-needed-to-boost-efficiency-of-global-cancer-trials-report/
- Published: 2025-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:25:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160162

A new report from the Reagan-Udall Foundation for the FDA is calling for broad operational and policy reforms to improve the efficiency, representativeness, and success rates of oncology multi-regional clinical trials. The [report](https://reaganudall.org/sites/default/files/2025-11/Oncology%20Clinical%20Trials%5FPaper%5FFinal%5F0.pdf?ref=fdaweb.com), *Improving Oncology Multi-Regional Clinical Trials*, summarizes findings from a 9/4 roundtable that brought together leaders from the biopharmaceutical industry, clinical research organizations, cancer trial sites, and patient advocacy groups. Participants discussed long-standing challenges in launching and conducting cancer trials across multiple regions and proposed a slate of actionable recommendations to accelerate site activation and patient enrollment.

The group’s recommendations focused on modernizing clinical trial infrastructure and operations. Key proposals included:

- Expanding the use of network-based trial models to increase efficiency;
- Streamlining contracting and budgeting for U.S. trial sites;
- Shifting toward patient-centric enrollment strategies;
- Ensuring new technologies deliver measurable benefits;
- Harmonizing training and compliance activities across institutions; and
- Developing science-based standards for trial representativeness and generalizability.

Participants also emphasized the need for “short-term operational fixes” for ongoing trials as well as longer-term structural reforms. The report underscores that federal and state policy support, including tax and funding reforms for medical research infrastructure, will be critical to realizing these goals.

The Foundation’s report comes amid mounting concerns about the cost and complexity of oncology research. According to the paper, oncology trials now account for 41% of new global studies, yet they remain the most complex and time-consuming, with a success rate of just 5.1% compared with 19.1% for infectious disease trials. The average oncology Phase 2-3 protocol lasts nearly 1,600 days, roughly 50% longer than non-oncology trials.

Rising data demands and costs are also straining the ecosystem. Phase 3 oncology trials now generate about 4.9 million data points, nearly triple the volume collected a decade ago, while the combined cost of clinical research organization and technology vendor services has more than doubled since 2010.

The Foundation said it hopes the recommendations will serve as a roadmap for sponsors, regulators, and research institutions to advance both operational reforms and scientific rigor in cancer trial development.

“Multi-regional oncology trials are essential to bringing new cancer therapies to patients faster,” the report notes. “Achieving sustainable improvements will require cross-stakeholder collaboration and a shared commitment to efficiency, quality, and equity.”

A detailed list of the roundtable’s recommendations, responsible stakeholders, and projected implementation timelines is included in the report’s appendices.