CN2 - A public involvement process to enhance diversity in technology clinical trials

Background

Clinical trials exist to determine safety and efficacy of emerging interventions and should be representative of all patients. The digital Experimental Cancer Medicine Team (dECMT) conducts technology clinical trials (TechCT) to develop new technologically-enabled healthcare pathways through patient involvement. However, there is a growing appreciation of the digital divide in healthcare technology which may limit access to technologically-enabled healthcare pathways.

Methods

A collaboration between Vocal (a Manchester-based not-for-profit organisation which brings people and health research together) and dECMT facilitated 3 half-day workshops over 6 months. These involved patients and their representatives from diverse backgrounds, healthcare workers and researchers with an interest in digital healthcare and inclusion. Participants were reimbursed for their time. The aim of the workshops was to create inclusivity guidance for development of TechCT across the Greater Manchester Region (GMR), ensuring that technologically-enabled healthcare pathway development is designed for all.

Results

The 3 key stages of developing, establishing and running a TechCT were discussed and evaluated. This enabled all participants to interrogate each stage and process for opportunities to encourage inclusivity. Presentations, groups discussion and case studies were used to generate discussion and highlight areas for change. The outcome of this work has also been compiled into a guidance document and infographic for easy use, and will be shared with researchers across GMR via an established forum and with partners in the UK and Europe. It will also be fed back to the participants.

Conclusions

This process helped us to reflect on trial design from different perspectives. The workshops highlighted immediate changes we could make and changes to trial management processes and communication that we will adopt in our trial processes. More broadly, it highlighted the value of collaborating with others to both question practice and identify solutions. The legacy of this project will be to make our processes and practice more inclusive in all future TechCT, and to contribute to the wider discussion of addressing the digital divide in clinical research.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Manchester Academic Health Science Centre (MAHSC).

Disclosure

D.M. Graham: Financial Interests, Personal, Advisory Board, Consulting role on advisory board: Clinigen; Financial Interests, Personal, Invited Speaker: Cancer Drug Development Fund; Financial Interests, Personal, Advisory Board: McCann Health; Financial Interests, Institutional, Invited Speaker, Institutional funding from study: MSD, Codiak Biosciences, Starpharma, Faron Pharmaceuticals, Synthon, Janssen; Financial Interests, Institutional, Other, Sub-I: Institutional funding from study: AstraZeneca, Roche, BerGenBio, GlaxoSmithKline, Bayer, Bicycle pharmaceuticals, Carrick, Taiho Pharmaceuticals, CytomX Therapeutics, RedX Pharma PLC, Eisai Inc, Octimet, Orion Pharma, Kinex pharmaceuticals, Boehringer Ingelheim, BMS, Turning Point Therapeutics, Immutep, Agalimmune, Kymab, Blueprint, Astellas, Cellcentric, UCB Biopharma USL, Eli Lily, Seagen, Repare Therapeutics, Timepoint Therapeutics, Astex, Stemline, Crescendo Biologics Ltd, ADC Therapeutics, Genentech, Avacta Life Sciences Ltd, Nurix Therapeutics Inc; Financial Interests, Institutional, Other, Sub-I: Institutional finding from study: Chugai Pharmaceuticals; Financial Interests, Institutional, Invited Speaker: Incyte. All other authors have declared no conflicts of interest.