The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting highlighted transformative shifts in oncology—advances not only in drug development but also in trial methodology, biomarker strategy, patient inclusivity, and data intelligence. For biotech innovators and sponsors, the message is clear: success in this next era of oncology requires a partner who is as agile and forward-thinking as the therapies being developed. Contract research organizations (CROs) are helping sponsors integrate these emerging trends into smarter, faster, and more inclusive clinical trials. 

In this recap, we break down the top oncology clinical research trends from ASCO 2025 and what they mean for your next study.

 

1. ctDNA & Liquid Biopsies Go Mainstream for Trial Stratification

Circulating tumor DNA (ctDNA) continues to demonstrate powerful utility in identifying minimal residual disease (MRD), detecting recurrence earlier, and guiding treatment escalation or de-escalation. ASCO 2025 featured Guardant Health’s landmark data on ctDNA-informed adjuvant therapy in colorectal cancer and AstraZeneca’s use of ctDNA to guide endocrine treatment in the SERENA-6 trial for ER+/HER2- breast cancer.

Why it matters: 
Sponsors designing trials with biomarker-driven endpoints must incorporate real-time, minimally invasive monitoring tools. CROs can support the integration of liquid biopsy technologies with rigorous operational support and biomarker strategy, ensuring smarter patient stratification and faster go/no-go decisions. 

 

2. AI in Oncology Trials: From Hype to Execution

Artificial intelligence is no longer theoretical in oncology research—it’s becoming embedded across the trial continuum. Highlights from ASCO 2025 included AI models outperforming human pathologists in HER2 assessment, tools for predicting patient response, and intelligent trial matching platforms that reduce screen failures.

Why it matters: 
AI adoption can lower trial costs, improve enrollment efficiency, and elevate data integrity. Sponsors benefit by partnering with CROs like TFS that are ready to incorporate AI-driven technologies into trial workflows, from protocol optimization to site selection and beyond. 

Learn more about the role and development of AI in clinical research in this article.   

 

3. Novel Modalities: ADCs, Bispecifics & First-in-Class Agents

The oncology pipeline is increasingly dominated by targeted and complex biologics. Data presented on Gilead’s Trodelvy + Keytruda combination and Innovent’s PD-1/IL-2 bispecific antibody (IBI363) illustrate the momentum behind antibody-drug conjugates (ADCs), bispecifics, and immune-modulating biologics entering earlier lines of treatment.

Why it matters: 
Advanced modalities require specialized operational and regulatory support. CROs can offer sponsors deep oncology expertise combined with global trial infrastructure—ensuring flexible execution for even the most sophisticated assets. 

 

4. Lifestyle, Obesity & Metabolic Factors Gain Clinical Priority

A paradigm shift is underway as cancer research increasingly intersects with metabolic health. ASCO 2025 featured groundbreaking data on structured exercise reducing colon cancer recurrence, and emphasized obesity as both a modifiable risk factor and therapeutic consideration in breast and gynecologic cancers.

Why it matters: 
Sponsors can explore lifestyle endpoints, digital health integrations, and real-world evidence strategies to differentiate their assets. TFS helps design holistic trials that reflect the evolving understanding of cancer biology and patient-centered outcomes. 

 

5. Rare Cancer Innovation: Global, Adaptive, & Patient-Centric

Rare cancers took center stage in ASCO’s push for equity and innovation. With smaller patient populations, rare and orphan oncology trials demand adaptive designs, global reach, and sponsor-CRO collaboration that minimizes delays and maximizes recruitment.

Why it matters: 
Mid-sized global CROs like TFS provide a size and structure that give rare oncology sponsors the best of both worlds: personal attention and global scalability. From site activation to regulatory navigation, we help sponsors bring hope to underserved patient communities. 

 

6. Driving Diversity: LGBTQIA+ Inclusion in Oncology Research

Coinciding with Pride Month, ASCO 2025 featured new insights into sexual orientation and gender identity (SOGI) data in cancer trials. A significant number of LGBTQIA+ patients still feel unsafe disclosing their identity in healthcare settings, limiting trial access and representation.

Why it matters: 
True innovation in oncology includes designing trials that welcome all patient populations. TFS supports inclusive trial strategies and builds DEI considerations into feasibility, site selection, and patient engagement plans. 

 

Conclusion

The landscape of oncology research is evolving—fast. Whether it’s leveraging ctDNA for adaptive trial designs, accelerating AI integration, or expanding into novel biologics and rare diseases, ASCO 2025 emphasized one thing: sponsors must move with precision, speed, and inclusivity. 

TFS is here to help! As a mid-size global oncology CRO with therapeutic depth, regulatory fluency, and operational agility, we’re your partner for navigating what’s next in oncology trials. 

Let’s build the future of oncology—together. 

 

TFS HealthScience: Your Global CRO Partner in Oncology & Hematology  

TFS HealthScience Oncology & Hematology CRO is dedicated to providing comprehensive services to support your oncology clinical trials. With a proven track record of over 300 cancer-related clinical trials across all phases globally, we’re committed to delivering solutions that match your needs. Our global operations teams are fully experienced with navigating the complex landscape of cancer clinical research, offering rigorous operational oversight and adherence to global standards. Visit our oncology CRO website to learn more or connect with a TFS representative here! 

To learn more about the expertise that TFS Oncology & Hematology CRO can offer for your next cancer trial, visit our page here.  

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