The 2025 Drug Information Association (DIA) Global Annual Meeting, held in Washington D.C., is beginning to wind down. As always, the conference has left a clear vision for the future of clinical trials. one defined by groundbreaking innovation, unprecedented global collaboration, and a profound commitment to patient well-being. This year's conference underscored key themes that are shaping the landscape of medical product development, with Artificial Intelligence (AI) and Real-World Data (RWD) taking center stage.
Medable unveils its new CRO partner program
Medable Inc., a leading provider of clinical development technology, unveiled its new Partner Program at DIA 2025, designed to empower contract research organizations (CROs) and other partners with generative AI-driven, self-service eCOA build capabilities for digitally enabled clinical trials. This program aims to eliminate traditional bottlenecks for CROs, accelerating timelines by 50% or more, while delivering administrative and financial benefits through straightforward, up-front pricing.
Medable's Partner Program offers CROs three models: self-service, managed-service, or a hybrid. It provides pricing tools, demo support for bid defense meetings, and a portfolio content library for reuse and scalability. The program also offers partial or full enablement to help CROs take control and drive higher margin services, leveraging GenAI for market differentiation. Regardless of the chosen support option, the Medable Partner Program facilitates a collaborative eCOA design experience for sponsors with real-time updates.
A significant advantage of the program is access to Medable Studio, an AI-powered solution for building, storing, and reusing eCOA instruments. Designed with CROs in mind, Studio enables self-service eCOA builds and trial deployments, providing CROs with more control and flexibility to scale operations. Non-technical staff can easily build assessments in minutes for various studies and therapeutic areas using Medable Studio's rich content libraries, translational workbench, virtual scheduling, AI-based point-and-click builder, and user-friendly interface.
Beyond technical advantages, Medable's Partner Program simplifies contractual relationships with upfront, consistent, and competitive pricing, streamlined communications, and on-demand support, reducing the need for change orders. This program puts CROs in control to confidently leverage AI and automation for faster, more efficient, and higher-quality studies, generate study-specific quotes in seconds, and enter any study kick-off or bid defense meeting with a pre-built digital study ready for instant feedback and updates.
Global collaboration and regulatory evolution
A central tenet of DIA 2025 was the resounding call for enhanced global regulatory collaboration and scientific integrity. The opening keynote panel, featuring leaders from the FDA, EMA, MHRA (UK), AAAS, and Vertex, emphasized the critical need for regulatory bodies to work together to accelerate the delivery of therapies and reduce global disparities in treatment access. Discussions highlighted the importance of mutual reliance between agencies and the proactive role of regulators in fostering ethical innovation. FDA Commissioner Marty Makary, for instance, stressed the need to learn from real-world data and synthetic controls, complementing traditional randomized, controlled trials. The concept of "international reliance and recognition" was highlighted as a key priority for global regulatory bodies.
The continued AI revolution in clinical research
The pervasive influence of Artificial Intelligence (AI) and Machine Learning (ML) was a dominant theme throughout the conference. A breakout session, led by Mary Jo Lamberti of Tufts CSDD, showcased a recent industry survey revealing significant adoption of AI/ML in clinical research. The survey, a collaboration between Tufts CSDD and DIA with 16 biopharma companies and CROs, found an average time reduction of 18% using AI/ML, with a positive overall outlook from respondents.
However, the path to full AI/ML integration isn't without its challenges. Panelists discussed the need for massive amounts of high-quality data, the importance of building trust in AI-generated results, and addressing intellectual property concerns related to data sharing.
Despite these hurdles, the enthusiasm for AI's potential was palpable. Industry leaders shared real-world use cases, including optimizing study protocols by analyzing data components like criteria and assessment schedules, calculating patient and site burden, and comparing trials with industry sponsors. Generative AI techniques are also being explored to improve productivity and open capacity for AI-driven insights. Looking ahead, the vision for AI includes digital twins, decision augmentation, and adaptive clinical trials leveraging generative AI for synthetic data generation.
Peter Ronco, CEO of Emmes, highlighted the often-underrecognized yet impactful role of the public sector, particularly the NIH and FDA, in advancing tech-enabled clinical development. These agencies have been pioneering the use of AI and large language models for tasks such as automating IND submissions, optimizing protocol design, and leveraging decades of complex data to improve trial execution and patient recruitment. Ronco emphasized that while AI enhances efficiency, human oversight remains essential. The ultimate vision includes AI-driven workflows becoming standard practice to reduce animal testing, improve regulatory processes, and address health disparities, all while establishing clear ethical and privacy standards globally.
Patient-centricity and health equity
A recurring message was the deepening commitment to patient-centricity. Discussions revolved around genuinely involving patients in clinical trial design and decision-making, moving beyond mere compliance. Innovations in digital health technology, including direct-to-patient approaches, wearable sensors, and connected devices, are transforming data collection and enhancing the patient journey within trials. AI is also aiding in better disease detection algorithms to identify disease burden early and connect patients with clinical trial options as a care alternative. Efforts are being made to measure and reduce patient burden during trial visits through elements like home healthcare and telemedicine.
Jimi Olaghere, a patient advocate who shared his personal experience with sickle cell disease and gene therapy, passionately urged the industry to move away from a solely "value-based healthcare system" and prioritize getting therapies to people as quickly as possible.
Breakthrough clinical trial results
The conference also served as a platform to discuss significant advancements in clinical trials:
- Tecentriq and Zepzelca combination for lung cancer: Positive data from the Phase III IMforte trial showed that the Tecentriq (atezolizumab) and Zepzelca (lurbinectedin) combination therapy significantly reduced the risk of disease progression or death by 46% and the risk of death by 27% in patients with extensive-stage small cell lung cancer (ES-SCLC). This combination may offer a new practice-changing option for a disease with high unmet need.
- Braftovi-based regimen for colorectal cancer: The Phase III BREAKWATER trial delivered the first statistically significant and clinically meaningful overall survival benefit in the first-line setting for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The Braftovi (encorafenib) plus Erbitux (cetuximab) and mFOLFOX6 combination showed a 51% reduction in the risk of death compared to standard-of-care chemotherapy.
- Enhertu plus Pertuzumab for breast cancer: AstraZeneca and Daiichi Sankyo shared positive data from the Phase III DESTINY-Breast09 trial, demonstrating that Enhertu (fam-trastuzumab deruxtecan-nxki) plus pertuzumab significantly improved progression-free survival (PFS) in patients with HER2-positive metastatic breast cancer. The combination reduced the risk of disease progression or death by 44% and achieved a median PFS of 40.7 months.
Breaking down silos and fostering innovation
A recurring theme in discussions around AI/ML adoption and overall industry efficiency was the need to break down information and functional silos. The importance of interoperability and integration of data systems was highlighted as crucial for accelerating processes and improving communication between stakeholders. The sentiment was that while silos were created for specific reasons, the current landscape demands seamless workflows and integrated processes to truly harness the power of new technologies.
DIA 2025 has truly set the stage for a transformative year in clinical research. The emphasis on collaboration, ethical AI implementation, and a steadfast patient focus signals a bright and promising future for medical product development worldwide.
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