APPRAISEMENT
Research type
Research Study
Full title
Developing an equity-focused Target Product Profile for non-invasive biomarker tests tailored to support mobile testing outreach programmes to reduce cancer inequalities.
IRAS ID
337809
Contact name
Patrick Kierkegaard
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Cancer outcomes are inequitably distributed with many studies reporting disparities falling disproportionately on people with lower socioeconomic status, certain minority populations, and those who live in geographically isolated areas. Detecting cancer early in asymptomatic individuals is crucial for addressing these disparities. Efforts enabling the early detection of cancer include testing delivered through screening programmes and advanced diagnostics available at secondary care settings. However, population-based testing using advanced diagnostics is not practicable due to the cost, capacity, and expertise required. Considering this, there is an urgent need for more targeted efforts in developing early detection testing strategies to efficiently reduce disparities among these populations groups.
In response, state-of-the-art non-invasive biomarker tests delivered through mobile testing clinics present a promising low-barrier outreach solution. These clinics, exemplified by the 'Man Van' program, offer improved testing access to underserved groups. However, an evidence gap exists in understanding how to effectively integrate these concepts. Identifying the necessary characteristics for developing non-invasive biomarker tests supporting mobile testing outreach programs is essential to overcome barriers driving cancer disparities.
In view of this, developing an equity-focused Target Product Profile (TPP) can provide a summary of the requirements for an optimal yet realistic profile of biomarker tests designed to address this evidence gap. Currently, no such TPP is available. The absence of a well-defined TPP can lead to a host of problems, where developers risk making certain assumptions and end up discovering at a late development stage that their biomarker test does not align with the realities of disadvantaged, underserved, and minority populations. As a first step to mitigate this risk, this project will develop a proof-of-concept TPP to identify the critical evidence requirements needed to develop non-invasive biomarker tests for use in mobile testing clinics to support early detection outreach programs.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
25/YH/0139
Date of REC Opinion
7 Jul 2025
REC opinion
Favourable Opinion