Strong partnerships and specialist expertise are key to the success of any Functional Service Provider (FSP) model. Through her role supporting Takeda, Beth McDougall works as an embedded statistical partner, providing expert oncology-focused support while collaborating closely with teams to deliver high-quality analyses and contribute to research that advances understanding across the oncology clinical trial landscape. In this blog, we share how a collaborative research project led to new insights into 25 years of oncology clinical trials and culminated in a presentation at the 2026 Joint Statistical Meetings (JSM).
As part of her role at Takeda, Beth provides expert FSP statistical support across multiple oncology compounds, contributing to a wide range of activities including the statistical review of clinical study reports (CSRs), interim safety analyses, ad hoc analyses and trial design support.
In late 2025, Beth’s Takeda manager identified an opportunity to undertake a research project examining trends in oncology clinical trials. The project was led by her manager, who defined the research question and overall analytical scope.
To support the study, Beth familiarized herself with the Aggregate Analysis of ClinicalTrials.gov (AACT) database, which served as the primary data source. Working collaboratively with her manager, she helped develop a comprehensive set of keyword search terms to identify the subset of oncology trials relevant to the analysis.
Beth’s primary contribution was leading the statistical analyses in R. She developed the analytical outputs, produced the tables and figures that formed the basis of the findings, and contributed to the methods and results sections of the resulting manuscript. Through this work, she helped transform a large and complex clinical trial dataset into a clear and evidence-based assessment of how oncology research has evolved over time.
Sharing Our Expert Insights with the International Statistical Community
Their work culminated in a presentation at the 2026 Joint Statistical Meetings (JSM), as well as a poster at the Central European Network (CEN) conference. Presenting the findings provided an opportunity to share insights with the wider statistical community and contribute to ongoing discussions about trial methodology, transparency and result reporting in oncology research.
The analysis revealed a dramatic increase in oncology clinical research activity, with the number of new trials launched each year growing more than five-fold between 2000 and 2024. Much of this growth was driven by an expansion in early- and mid-phase studies, reflecting the increasing number of therapies entering development.
The study also showed that endpoint selection remains closely aligned with traditional development pathways. Early-phase trials primarily focused on safety outcomes, while Phase II studies often used response-based endpoints. In later-stage trials, time-to-event measures and overall survival were more commonly used to assess treatment benefit.
While these findings suggest that oncology development continues to follow established clinical research paradigms, the analysis also highlighted areas for improvement. Information describing trial design characteristics was often incomplete, making it difficult to assess how studies were planned and conducted. Although public reporting of results improved following the introduction of regulatory requirements, fewer than one in four completed trials reported results within 12 months of primary completion.
Together, these findings provide a unique view of how oncology research has evolved over the last 25 years, while also highlighting the ongoing need for greater transparency and more comprehensive reporting to support future evidence generation, policy evaluation and clinical decision-making.
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