Embedding the public voice in clinical trials: developing public-informed training for patient data research

Area of Science:

• Health Systems Data (HSD) in Clinical Trials
• Participatory Health Research (PHR)
• Public and Patient Involvement and Engagement (PPIE)

Background:

• Health systems data (HSD) use in clinical trials is growing for efficiency and real-world relevance.
• Challenges in HSD trials include governance, data quality, transparency, and public trust.
• Limited public involvement in methodological and data-focused aspects of HSD trials necessitates improved training.

Purpose of the Study:

• To develop training resources for health systems data (HSD) trials that reflect public perspectives.
• To explore participatory health research (PHR) approaches for creating effective HSD trial training.
• To enhance the relevance, accessibility, and trustworthiness of HSD trial training through public involvement.

Main Methods:

• A Participatory Health Research (PHR) approach was employed within the HDR UK Transforming Data for Trials programme.
• A UK-wide Public Advisory Group (PAG) was recruited and engaged through virtual meetings.
• Two case studies demonstrated co-production for public-facing modules and consultative input for researcher-focused modules.

Main Results:

• The Public Advisory Group (PAG) comprised 25 diverse members who shaped training content.
• Co-production resulted in accessible, plain-English video modules on HSD topics for public partners.
• Consultative input refined a researcher-focused module on Data Utility Comparison Studies, addressing public concerns on accuracy and equity.

Conclusions:

• Co-production yielded accessible resources for public partners, while consultation improved researcher training on public trust.
• Integrating public perspectives strengthens HSD trial methodology training.
• This work offers a practical model for public involvement in methodological training for HSD trials.