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Day 1

2nd DECENTRALIZED & HYBRID CLINICAL TRIALS WORLD CONGRESS 2026 EUROPE

Patient-centric approach to Decentralized & Hybrid Trials: Understanding the changing landscape, the trends, challenges, and opportunities for a successful implementation.

London, United Kingdom

Day 1 - Wednesday 25th February 2026

REGULATORY GUIDELINES

  • Addressing varying regulatory guidelines for DCT
  • Emerging regulatory frameworks and approaches
  • Potential opportunities and challenges for DCT solution providers.
  • Regulations clarifying access to health technologies and technical requirements.
  • Adhering with data privacy laws and compliance
  • Lessons learned and future of DCTs

Moderator:

Panelist:

  • Brief overview of the current guidelines
  • ACT EU Pilot scheme for trials with decentralized elements
  • Harmonised and transparent approach for the use of DCT elements in clinical trials.
  • Review outlines of gap analysis focused on the frameworks and guidance
  • The need for a comprehensive sustainability assessment of each DCT element
  • Guidance related to a comprehensive assessment of designing and executing sustainable DCTs needed
  • Factors stakeholders regard as having the most significant impact on driving sustainability decisions in DCTs.

CURRENT TRENDS AND STRATEGIES

  • Current role of digital platforms in supporting decentralized trial activities
  • Challenges and benefits of digital platforms to investigators and participants
  • The obstacles developers must address before a fully integrated and unified DCT can be realized.
  • New tools and framework that facilitates progressive decentralization
  • Technological developments in telehealth
  • Important aspects to consider when conceptualizing a phase 1 decentralized clinical trial
  • Examples of promising model for early drug development.
  • Current adoption of remote monitoring and data collection technologies
  • Drivers of increasing adoption of remote monitoring and data collection technologies
  • Remote monitoring and data collection technologies with greatest outcomes associated with patient experience
  • Aspirations and direction for industry to enable more patient-centric trials.
  • Ethical aspects of digitalization in clinical trials associated with digital technologies
  • Informed consent in clinical research
  • Decentralized informed consent procedures that are impacted by digitalization
  • Electronic consenting technologies and procedures
  • Opportunities and Considerations
  • Data-Driven Solutions in Planning and Feasibility of Clinical Trials
  • Various decentralization components available for stakeholders to increase the reach and pace of their trials
  • Fit-for-Purpose, Usability Studies, and Contingencies
  • Examples of trials with dual DCT and DHT components
  • What is IRT and why use it for your trial?
  • Greatest challenges and obstacles to consider when selecting new IRT innovations?
  • Technical and operational considerations in selecting an IRT vendor
  • What are the benefits to look for?
  • Perspectives and guidance for effective eCOA in global DCTs
  • Preparations to implement eCOA in your global DCTs
  • What are the complexities of the eCOA process
  • Can technology play a pivotal role in achieving better outcomes?
  • Benefits of Decentralized Clinical Trials revolutionizing the way research is conducted
  • Key Components of Decentralized Trials reshaping the traditional model
  • Ethical standards and participant safety as crucial cornerstones of the research effort
  • Challenges and barriers in clinical research
  • Principles for successful Decentralization in Clinical Trials
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