NOVEL METHODOLOGIES
Innovative participant recruitment and collaboration
The CPTU leverages innovative approaches and technologies to conduct impactful epidemiological studies and clinical trials. By collaborating with NHS DigiTrials and providers like iPlato, we explore efficient participant recruitment methods for large-scale studies. We are involved in proof-of-concept projects that may inform other units manage recruitment and NHS patients are approached in the future.
Digital tools for participant engagement
We actively promote the use of mobile apps and electronic consent to reduce the burden on participants and the environmental impact as well as the cost to funders. For instance, the CPTU Behavioural Scientist conducted in-depth PPI interviews with individuals in target communities for the YORKSURe bladder cancer project. These interviews assessed the acceptability of novel data collection methods, such as mobile phone applications and web-based systems, to ensure community needs and preferences were met.
Electronic records for long term follow-up
To facilitate long-term outcome studies, the CPTU continues to pioneer the use of electronic health records for extended follow-up, working with NHS Digital and other data providers to implement more efficient approaches to long-term data collection. For example, in the GRAIL (NHS-Galleri) and BEST4 projects, we utilise health registry data to achieve study objectives while minimising the need for duplicate data collection in secondary care.
Dynamic recruitment algorithms
We use novel data-enabled approaches to recruitment that are designed to address healthy volunteer effects and inequity in health research studies. For NHS-Galleri and BEST4 Screening Trial, a computer algorithm was developed to help target trial invitation. Public data sources were used for objective function weights, and constraints. Invitations were sent by by sampling according to lists generated by the algorithm. To enhance equity, the algorithm tilts the invitation sampling distribution towards groups that are less likely to join.
Advanced methods and novel paradigms
We also study and apply advanced methods to maintain randomised comparisons, despite challenges like non-compliance or opportunistic cross-over, and novel paradigms to enable smaller trials with multiple treatment arms . Key examples include:
- BEST4 Screening Trial: Using a Zelen design within a cohort study to preserve statistical power by facilitating participation of control arm individuals who receive standard care treatment.
- YORKSURe Trial: Implementing a conceal-reveal design to increase statistical power and a reciprocal design for greater ethical acceptability.
- Finesse Trial:
Employing a pragmatic study design with open-label pharmacy stock to significantly reduce costs compared to a double-blind trial.
Decentralised trial delivery
We employ decentralised trial delivery methods in the forms of central invitations and mobile research units to reduce the burden on traditional clinical sites and increase recruitment and community engagement.