Archives: Agenda

This session will explore recent findings from the Tufts Center for the Study of Drug Development (CSDD) on the current landscape of decentralized clinical trial (DCT) solutions, addressing key questions including:

• How are DCT solutions being funded, and to what extent?
• How are resources being deployed for DCT implementation across research site types?
• Which DCT solutions are most heavily funded and supported?
• What are participant and site perspectives on direct-to-participant investigational products – what’s working and what’s challenging?

• Identifying the key decision points that shape an oncology program’s trajectory
• Making faster, more informed go/no-go decisions through cross-functional insights
• Recognizing differentiation opportunities and reducing development uncertainty early
• Accelerating development and strengthening competitive positioning in a crowded market

LinkedIn Prize Draw

To be in with a chance of winning our LinkedIn prize draw on day 2, post your most engaging and/or funniest photo from Day 1 of the conference on LinkedIn by 8:00pm on June 30^th.

Please include the hashtag #CTO and tag both:

• Clinical Trials in Oncology Event Series
• Arena International Events Group

We will shortlist three finalists, and the audience will vote for the winner during the Chairpersons’ Opening Remarks on Day 2.

Please note. You must be present in the room at 8:45am to claim the prize. If the winner is not present, the prize will be awarded to the next finalist in attendance.

• Synthetic populations and AI-simulated control arms are already reducing reliance on traditional randomization
• Real-time, adaptive approval models could replace rigid phase boundaries
• Continuous post-market learning may become as important as pre-market proof
• Decision-making authority shifts as AI accelerates evidence generation beyond human-paced review cycles

• Changing how researchers select potential patients for better success rates
• How has regulation changed and what to expect?
• How to improve drug efficacy and patient safety before it’s too late
• Back to square one: Differentiating with simpler, patient-centric protocols and optimized study design
• Avoiding disappointing results by implementing the right technology tools to advance your trial
• Lessons learned to mitigate trial failures

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials

• Integrating the right biomarker to narrow relevant patient groups and optimize and personalize disease management
• Engaging with the oncology community and advocacy groups to grow involvement of well-informed patients
• Leveraging investigator expertise for pragmatic trial designs and patient identification
• Building the evidence, from natural history to endpoint development, to support informed decisions by health authorities
• Modernizing criteria: Moving beyond traditional cut-offs to include underrepresented populations safely

Moderator: Nekia Clark, Director of Community Engagement & Outreach, Ellie Fund

• Shift trial success toward speed and quality of decisions, not just endpoints, by embedding patient journey insights early.
• Enable precision enrollment and site activation through integrated data (EHR, genomics, biomarkers) and real-time feasibility.
• Use Biomarkers/MRD/ctDNA and real-time data flows to drive adaptive treatment decisions and improve patient outcomes.
• Operate within a connected partner ecosystem (sponsor-CRO-diagnostics) to deliver faster, more reliable, decision-grade evidence.

• Challenging the perception of Europe as a backup option for oncology trials rather than a strategic development partner
• Sharing practical lessons from running four concurrent Phase II oncology studies across Europe, with a strong focus on Poland
• Examining the operational, recruitment, and cost advantages that can make Europe a compelling choice for clinical-stage biotechs
• Highlighting what worked, what didn’t, and the key considerations sponsors should evaluate before defaulting to traditional trial geographies
• Exploring how early integration of European sites can strengthen global development strategies and accelerate clinical progress

• Recognizing how the geographic concentration of oncology trials can limit the global relevance of regulatory evidence
• Understanding the role of genomic and epigenomic variation across ancestries in driving treatment response and toxicity
• Identifying how environmental and contextual factors interact with biology to influence therapeutic outcomes
• Evaluating how conventional eligibility criteria may exclude biologically relevant patient populations
• Learning the principles of ancestry-aware eligibility design as a scientifically rigorous approach to trial inclusion
• Assessing how eligibility reform can improve the predictive validity of clinical trial data for regulators and sponsors
• Applying ancestry-aware trial design concepts to support equitable, efficient, and globally applicable drug approvals