Sydney, Australia, December 2025, Novotech, a leading global full-service clinical research organization (CRO) and scientific advisory company, has released a new white paper, Early-Phase Oncology – Clinical Research Landscape and CRO Enablers (2025), offering in-depth analysis of the key drivers shaping early-phase oncology development.
With approximately 60% of oncology agents progressing from Phase I to Phase II, but only 3–6% reaching regulatory approval, the paper outlines the factors influencing early-stage success, including trial design, patient selection, and regional development pathways.
The paper highlights Australia’s continued position as a global first-in-human (FIH) and early-phase research hub. Its ethics-led review frameworks, which can support trial initiation within roughly 4–8 weeks, combined with established FIH centers, oncology networks, and cost efficiencies, position Australia as a practical starting point for programs that later expand into the US, Europe, and broader Asia markets.
The analysis provides biotech and pharmaceutical sponsors with analysis of how modern trial methodologies, precision-based approaches, and coordinated global execution are shaping early-phase oncology. It also highlights Novotech’s role in supporting these programs through scientific expertise, regulatory alignment, and access to more than 5,500+ trial sites worldwide.
Key areas covered:
- Global Early-Phase Oncology Landscape: Geographic trends, therapeutic innovation, and investment momentum driving new oncology pipelines.
- Emerging Trial Designs: Adaptive, biomarker-driven, and decentralized models improving speed, inclusivity, and data quality.
- Regulatory Shifts: The impact of initiatives such as the U.S. FDA’s Project Optimus in advancing evidence-based, patient-centric dosing strategies.
- Novotech’s Role as a CRO Partner of Choice: The organization’s early-phase oncology expertise and technology-driven model help sponsors manage risk, shorten timelines, and strengthen data quality.
Download the white paper: Early-Phase Oncology – Clinical Research Landscape and CRO Enablers (2025)
媒體聯絡人
Toyna Chin
關於Novotech Novotech-CRO.com
Novotech是一家可提供全方位服務的國際性受託研究機構 (CRO) 和科學諮詢公司，在藥物研發的各個階段提供指導，深受生物技術公司及中小型製藥公司的信賴。
Novotech的業務涉及全球多個國家和地區，在亞太地區、北美和歐洲設有30多個辦公據點，並與7,000多個試驗機構建立了緊密的合作關係，透過提供關鍵臨床試驗資源網絡、廣泛接觸不同的受試者群體，幫助客戶將前沿的治療方法加速推向市場。
Novotech透過以客戶為中心的服務模式，將人員、流程和技術無縫整合，提供定制化解決方案，推動變革性的治療方法進入市場。Novotech採用真正的合作夥伴關係模式，堅定地致力於幫助客戶取得成功、推動創新並促進全球醫療保健的發展。
Novotech憑藉卓越的臨床試驗執行和創新能力獲得了眾多業界榮譽。Novotech在臨床以及法規方面深厚的專業知識，以及對本地市場的深刻洞察，使其能夠為臨床試驗的順利進行、資料分析的強化以及加速受試者招募策略方面提供有力支援。
Novotech與客戶攜手，將科學進步轉化為能夠改善全球健康狀況的治療方法，實踐推動創新、創造卓越成果的使命。
如需瞭解更多資訊或與專家團隊成員洽談，請造訪www.Novotech-CRO.com