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)
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Toyna Chin
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Novotech（诺为泰）作为一家可提供全方位服务的国际性临床研究组织 (CRO) 和科学咨询公司，深受生物科技公司以及中小型制药公司的信赖，并指导其在各个阶段的药物开发。
公司在全球范围内拥有30多个办公地点，主要分布在亚太地区、北美和欧洲，并与5000多个试验机构建立了紧密的合作关系，为客户提供丰富的临床试验资源网络，帮助客户充分利用关键试验区域，广泛接触不同的受试者群体，推动变革性疗法更快惠及患者。
通过以客户为中心的服务模式，诺为泰无缝整合人才、流程和技术，提供定制化解决方案，加速变革疗法快速上市。通过构建紧密的合作伙伴关系，诺为泰坚定不移地支持客户实现研究目标，赋能创新，推动全球医疗健康发展。凭借在临床试验执行和创新方面的卓越表现，诺为泰已荣获多项殊荣，包括连续19年蝉联弗若斯特沙利文CRO年度公司奖 (Frost & Sullivan CRO Company of the Year)。依托深厚的临床领域与监管专业知识，结合对当地市场的深刻洞察，公司致力于简化临床试验流程，优化数据分析，并加快受试者招募策略的实施。
我们与客户携手并进，加速科研成果的落地转化，改善全球患者结局，践行我们推动创新、实现卓越成果的使命。
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