Novotech, a global full-service clinical research organization and scientific advisory firm, has announced the release of a new white paper titled Early-Phase Oncology Clinical Research Landscape and CRO Enablers 2025. The publication takes a close look at the forces shaping early oncology development and provides practical insight for sponsors navigating increasingly complex clinical pathways. The paper is designed to help biotech and pharmaceutical companies make more informed decisions during the earliest and most critical stages of oncology research.
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Drawing on industry data, the white paper notes that while nearly 60 percent of oncology therapies advance from Phase I into Phase II, only a small fraction ultimately receive regulatory approval. This sharp drop highlights the importance of strong foundations in early development. According to the analysis, success at this stage is heavily influenced by factors such as thoughtful trial design, accurate patient selection, and the choice of regions used to initiate development programs.
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A significant portion of the paper focuses on Australia and its continued role as a preferred location for first-in-human and early-phase oncology studies. The country’s ethics-driven review processes often allow trials to begin within four to eight weeks. When combined with experienced early-phase centers, well-connected oncology networks, and favorable cost structures, Australia offers sponsors a practical entry point before expanding into the United States, Europe, and other Asian markets.
The report also examines how early-phase oncology research is evolving through the use of modern trial approaches. Precision-based strategies, adaptive study designs, and better coordination across global regions are changing how early data is generated and used. These shifts are helping sponsors move faster while maintaining data quality and patient safety in an increasingly competitive environment.
John Moller, Chief Executive Officer at Novotech, shared that the goal of the white paper is to give sponsors a clearer view of what drives success in early oncology development. In his words, understanding how science, regulation, and execution intersect at this stage can significantly reduce risk later in the pipeline. He added that early alignment across these areas allows promising therapies to progress with greater confidence and efficiency.
The paper also outlines Novotech’s role in supporting early-phase oncology programs worldwide. With scientific and regulatory expertise and access to more than 5,500 clinical trial sites globally, the organization helps sponsors streamline execution, manage complexity, and build strong data packages that support future development and regulatory discussions.
Overall, the white paper serves as a practical resource for companies seeking to strengthen their early-phase oncology strategies by combining innovative trial methods, regional insights, and experienced global execution.
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