PRIMORANT

Co-produced and stakeholder informed training for trial teams working with routinely collected health data.

Background

There are many benefits, for both trialists and the public, of using routinely collected health data (or healthcare systems data) in clinical trials. These include cost savings, and reduced burden on site staff and trial participants relative to traditional data collection approaches that can involve administering repeated questionnaires or tests.

However, research suggests that there is low public awareness that some of this data can be used for research, and that researchers must work to establish a ‘social license’ for using people’s routine data in this way. This involves working with the public to be transparent about how routine data will be kept safe and secure by trial teams, and what the public benefits of this approach are.

We were funded by HDR UK to develop training for clinical trialists that helped them to “build and maintain public trust in routine data trials”.

Developing the training

To develop the training, we worked closely with a range of stakeholders. Some of that work included:

• A questionnaire survey of all UKCRC Registered Clinical Trials Units
• Discussions and interviews with subject matter experts
• Discussions and interviews with public involvement and engagement leads from organisations such as HDR UK and ADR UK
• Discussions with representatives from routine data providers such as NHS England and SAIL
• A workshop with public partners

This background work helped inform the scope and detail of the training course, and we were able to integrate recorded clips of stakeholders into the training videos.

Topics covered

The training course comprises of five modules, each made up of a number of ‘bite-sized’ talking head videos. There are also links to infographics and key resources. The training was developed in close collaboration with HDR UK’s training team.

The course is intended for trial team members who work with – or are interested in working with – routine healthcare data in their trials.

Modules include:

1. Introduction
2. Drivers of public trust in routine data
3. Public involvement and engagement, and inclusivity
4. Communicating clearly about routine data
5. Evaluating costs and impact

Next steps

The Centre for Trials Research are involved in the recently-funded HDR UK workstream, ‘Transforming Data for Trials’, which aims to help realise the potential of healthcare systems data to transform clinical trials in the UK.

As part of this work, our team in Cardiff will build on the PRIMORANT work to identify training needs and develop training materials for researchers and other stakeholders on a range of different routine data topics.