INTERACT - Understanding inclusivity in oncology clinical trials: a data-driven approach

Development work questions Who is underrepresented amongst cancer clinical trial participants? What data do NHS Trusts collect and audit about patient demographics and trial participation? Who are the key stakeholders who can help address any gaps we find?

Background Despite increasing recognition of the need to prevent anyone being left behind by research, there are no country-wide datasets available in the UK exploring cancer trial participation and under-representation.

Without these data, targeted assessment and validation of interventions to improve representation from underserved groups, cannot be conducted.

Aims Our aims are to obtain robust quantitative data on representation of oncology trial participants in comparison to the incident population, assess current data collection standards and foster collaborations with diverse patient and public, NHS and research expert stakeholders.

Objectives Characterise inclusivity within our cancer trials, using routinely-collected healthcare data, comparing against the incident population during the equivalent time-period to identify exclusion of any groups.

Assess UK-wide NHS practice of recording and auditing patient demographics and trial participation and obtain a snapshot of current practice in trial recruitment at selected NHS sites.

Develop collaborations with diverse patient and public representatives, NHS stakeholders and multidisciplinary researchers for a future programme grant application.

Development work plan Data held centrally by NHS England will be requested for the 1.2 million people diagnosed with early-stage bladder, breast, head and neck, prostate and testicular cancer between 2007-2021. 20,100 ICR-CTSU trial participants (representing 44% of those joining similar trials in the same period) will be flagged in the records, accessed for analysis via NHS England s Trusted Research Environment.

The records will be analysed to identify any groups under-represented amongst trial participants, taking an intersectional perspective.

NHS Trusts will be surveyed about current demographic and trial participation data collection and a pilot study will be conducted at selected Trusts to investigate current practice in oncology trial inclusion, including review of verbatim text in medical records to identify data not captured in standard NHS data fields.

Multidisciplinary collaborations will be built by leveraging our existing links with patient groups, researchers and NHS Trusts across the UK, with targeted outreach to representatives and expert researchers involved with groups confirmed to be underserved by cancer trials. Timelines for delivery We will deliver the project within two years of grant start.

Whilst ambitious, we believe this to be feasible with dedicated project staffing, expertise within the team and determination of the applicants to establish a foundation against which future improvements in inclusivity can be measured.

Impact and dissemination Our results will be presented, published and disseminated via lay summaries and patient and public organisations.

We anticipate the results will be valuable to the NHS and UK research community, however our ultimate goal is to use them as a basis to develop a programme grant to develop an evidence base for feasible, effective and value-for-money interventions that improve inclusion from groups confirmed to be underserved, for which there are currently no proven strategies for improvement.