Brain Health Community Assessment for Trials Service

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:

Brain Health 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:

1. Appointment booking system that enables participants to book appointments directly through a portal;
2. Booking system able to receive information from and interface via secure integration with data partners;
3. Telephone and email support with appointment booking if needed by participants;
4. Identity check and verifying or obtaining informed consent;
5. Complete 10,000 appointments - one appointment per participant to deliver;

• community phlebotomy service;
• digital cognitive and 'day-to-day function' assessment performed using electronic device in a quiet location;
• physical measurements: height, weight, blood pressure;

6. Blood sample processing;
7. Sample storage, tracking and shipment to a chosen UK location(s);
8. Data collection, storage and sharing.

The service required will be a pilot with appointments across England, 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 and provide flexible service times which accommodates those who have daytime commitments. 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, future phases of which will include coverage of the four nations of the UK, subject to a separate procurement process.