Patient-reported outcomes

Generating evidence and guidance to inform equitable patient-reported outcome collection in early phase trials to inform regulatory decision making.

Patient-reported outcomes (PROs) provide essential safety and tolerability data to inform clinical care and regulatory decisions. However, their use in early phase settings and the integration with clinical/wearable devices to support interventions is limited. Trials using PROs often fail to address cultural/health needs of under-served populations.

This theme will address UK Government’s vision to create a ”patient-centred, pro-innovation, digitally-enabled clinical research environment”. It will empower everyone in the NHS to participate in delivering research. It will ensure that patients from across the UK can take part in research that is of relevance to them, thus addressing “unacceptable health inequalities.”

To achieve our goals, we will work with a range of international stakeholders including patients, industry partners, international regulators, healthcare professionals and academics. We will review the evidence on the use of AI and PROs to inform earlier diagnosis, risk stratification, intervention, and better outcomes. We will explore participation from under-served populations in qualitative research, their engagement in co-design of ePRO systems which meet their needs, including the use of culturally validated tools. Building on our previous work, we will generate international guidance for PRO assessment of symptoms/adverse events in early phase trials.

The inclusion of PROs in research through design, delivery and evaluation will increase the value of research results, helping to protect patient safety, respect their priorities and address their preferences. These steps are particularly important in multi-cultural environments such as the population served by the BRC.