Brain Health Clinical Trials Community Assessment for Trials Service

Description

Health Data Research UK (HDR UK) and the UK Dementia Research Institute (UK DRI) invite expressions of interest for the provision of a Brain Health Clinical Trials Community Assessment for Trials Service. The service is a critical component of the Dementia Trials Accelerator (DTA) programme which is supported by the Dame Barbara Windsor Dementia Goals programme and funded by the Medical Research Council (MRC). Lot 1: Programme Vision: The DTA vision is for the UK to become the destination of choice for late-phase clinical trials in dementia and neurodegenerative diseases. The aims of the DTA are to: 1. Increase trial recruitment by identifying potential participants in trials by creating a "biomarker toolbox". This toolbox will incorporate one or more of: genetic or clinical risk scores, blood-based biomarkers and clinical measurements of subjects living with or at risk of dementia and related neurodegenerative disorders 2. Work with existing UK patient or population cohorts to approach people for clinical trials to identify potential participants 3. Accelerate low-cost delivery identification of potential participants in dementia and neurodegenerative trials with community-based, digitally enabled, trial pre-screening 4. Accelerate collaborative neurodegenerative research through assembly of a secure UK-wide AI-enabled data platform that makes multi-dimensional FAIR (findable, accessible, interoperable, reusable) through trustworthy and secure data environment(s) 5. Prioritise the needs of industry innovators, patients and the public with an iterative engagement with stakeholders Service Required: The Brain Health Clinical Trials Community Assessment for Trials Service is central to this vision. It will provide pre-screening for a range of dementia and neurodegenerative clinical trials close to where people live as recommended by the O'Shaughnessy Review. The appointed provider will deliver comprehensive services, including: • Participant appointment and consent management • Blood sample collection by community-based phlebotomy services • Secure preparation, storage, and transportation of samples to designated UK locations • Data collection and secure sharing with contracting authorities The service required will be a pilot, initially operating across 4-10 locations in England, Scotland, and Wales, with plans to expand to underserved areas. The aim is to identify up to 10,000 potential trial participants over one year. Providers must ensure accessibility by offering flexible appointment times, including evenings, weekends, and bank holidays. They must also comply with regulatory standards for sample handling, participant confidentiality, and data security. This procurement marks the first phase of a broader initiative. Additional information: HDR UK and UK DRI wish to invite interested providers to engage with us prior to a procurement in early 2025. The purpose of engagement will be to gain provider input into: • Determine the level of provider interest • Inform development of service specification/s and collaborative service delivery options • Procurement process design • Help enable providers to participate in the process • Help inform the commercial model and contract terms HDR UK and UK DRI are preparing a pre-recorded session to provide additional details. Please check the link referenced above on Wednesday, 11th December, for more information. One-to-one meetings will be scheduled throughout December 2024 and January 2025 for deeper discussions as required at authority sole discretion.