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作為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，深受生物科技公司以及中小型製藥公司的信賴，引領其在各個階段的藥物開發。
公司在全球各地擁有30多個辦公據點，主要分佈在亞太地區、北美和歐洲，並與5000多個試驗機構建立了緊密的合作關係，為客戶提供豐富的臨床試驗資源網絡，幫助客戶輕鬆進軍關鍵試驗區域，廣泛接觸不同的受試者群體，推動變革性療法更快嘉惠患者。
透過以客戶為中心的服務模式，Novotech無縫整合人才、流程和技術，提供定制化解決方案，加速變革療法快速上市。透過建立緊密的合作夥伴關係，Novotech堅定不移地支援客戶實現研究目標，賦能創新，推動全球醫療健康發展。憑藉在臨床試驗執行和創新方面的卓越表現，Novotech已榮獲多項殊榮，包括連續19年蟬聯Frost & Sullivan CRO年度公司獎 (Frost & Sullivan CRO Company of the Year)。憑藉深厚的臨床領域與監管專業知識，再結合對當地市場的深刻洞察，公司致力於簡化臨床試驗流程，提升資料分析，並加快受試者招募策略的實施。
Novotech與客戶攜手並進，加速科學研發成果轉化為療法，改善全球患者結果，充分體現我們推動創新、實現卓越成果的使命。
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