Overview: Clinical trials are essential for evaluating new treatments, and there is growing interest in harnessing health systems data (HSD) to enhance their efficiency and effectiveness. HSD can offer researchers and trialists valuable opportunities to streamline key processes such as identifying eligible participants, monitoring trial progress in real time, enabling remote follow-up and capturing outcomes. Yet, its use also presents challenges, as researchers must navigate complex regulatory and legal frameworks that can hinder broader adoption.

Aim: In this masterclass series, we aim to explore how HSD can advance clinical research, with a particular focus on decentralized and large simple trials. By examining the challenges and sharing lessons learned, the talks will highlight practical strategies, methodological considerations and opportunities to strengthen the integration of HSD into trial design and execution.

A further hands-on session relevant to all clinical trial roles particularly DPhils and ECRs will explore some useful resources and skills for researchers to develop and optimise their trial design.

Agenda:
12:00 – 12:45: Networking & Light Lunch

12:45 – 13:00: Welcome & Introduction

13:00 – 13:20: Challenges in undertaking decentralized clinical trials using health systems data in primary care settings
Speaker: Professor Ly-Mee Yu

13:20 – 13:40: Supporting large simple trials with healthcare systems data: lessons learned
Speaker: Associate Professor Marion Mafham

13:40 – 13:50: Q&A

13:50 – 14:10: Panel Session: Unlocking Health Systems Data for Clinical Trials: Challenges and Opportunities
Moderator: Professor David Preiss (Professor of Metabolic Medicine and Clinical Trials, Oxford Population Health)

Panel: Professor Ly-Mee Yu (Professor of Clinical Trials and Biostatistics, Primary Care Clinical Trials Unit) Associate Professor Marion Mafham (Associate Professor, Oxford Population Health) Dr Charlie Harper (Trial Data Scientist, Oxford Population Health) Ms Lucy Cureton (Senior Trial Manager, Primary Care Clinical Trials Unit)

14:10 – 14:20: Audience Q&A and close main session

14:20 – 14:40: Break

14:40 – 16:00: Hands-on Session: Incorporating health systems data when planning a trial
(Relevant to all clinical trials roles particularly DPhils and early-stage researchers)

Facilitators: Professor Ly-Mee Yu, Associate Professor Marion Mafham, Dr Charlie Harper, Dr Michelle Goonasekera and Ms Lucy Cureton

In this session participants will discuss and find real-time solutions for challenges in using HSD to streamline clinical trials based on real clinical trial scenarios.

16:00 – 16:30: Networking and close