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Work Package 24 - Clinical recruitment and research facilities

PI/Lead: Vanessa Raymont, Oxford – Theme Lead and Associate Director

Start date:   Jan 2021                                                                                                          End date: Dec 2025

Objective of project

To provide an efficient recruitment and delivery infrastructure for early symptomatic clinical trials

Background:

Recruitment to studies for symptomatic disease is best done close to the clinical research facility. This can be achieved by developing co-located networks for clinical enrolment and recruitment. For enrolment to prodromal and early symptomatic studies a clinical research register will be developed from existing research registers at specialist research facilities and research active memory clinical sites. This will begin by recruiting from 2-3 key ‘demonstrator sites’. These sites will be selected to create a trials delivery infrastructure for efficient and targeted recruitment to and conduct of multi-centres trials. The network will then be expanded to other sites around the UK.

Work will then be conducted to achieve a consensus on a potential cognitive screening tool to be utilised at these sites, including digital options. Sites will be linked to developing ‘brain health’ service models being set up at memory clinic sites across the UK and will aim to collaborate with other similar networks internationally (e.g., Global Alzheimer’s Platform (US), Brain Health Scotland), to create a wider network for trial delivery.

 

Objective 1: Build a clinical network for recruitment and trial delivery.

Deliverable 1: Perform a scoping exercise of activities across research facilities and memory clinics.

Deliverable 2: Obtain agreement with 2-3 facilities to become demonstrator sites.

Deliverable 3: Set up the infrastructure at the demonstrator sites.

Deliverable 4: Expand the clinical network to another 4 UK sites.

Deliverable 5: Data collated and shared on recruited participants.

Deliverable 6: At least one research trial commenced on network participants.

 

Objective 2: Achieve a consensus on a cognitive screening tool.

Deliverable 7: Review and compare the cognitive screening tools used across sites.

Deliverable 8: Select a cognitive screening tool to use across the clinical network.

Deliverable 9:  Establish the use of the selected cognitive screening tool across the clinical network.

Deliverable 10: Cognitive screening tool performance data compared with the clinical outcomes across sites.

 

Objective 3: Collaborate with other similar networks internationally (e.g., Global Alzheimer’s Platform (US), Brain Health Scotland), to create a wider network for trial delivery.

Deliverable 11: Expand the profile of the clinical network.

Deliverable 12: Identify and establish collaborations with other memory clinic sites across the UK.

Deliverable 13: Identify and establish international collaborations.

Deliverable 14: Development of agreed best practice from collaborations.

Deliverable 15: Data from network shared across collaboration sites.

 

Objective 4: DPUK/MRC project reporting

Deliverable 10: Quarterly reporting

Deliverable 11: Annual reporting

Deliverable 12: End report

Deliverable 13: Financial reporting

 

Objective 1: Build a clinical network for recruitment and trial delivery

Specifics

Description

How and who

Outcome

Dates

Deliverable 1: Perform a scoping exercise of activities across research facilities and memory clinics

M1.1.1

Scoping exercise

Send scoping questionnaire to all sites & collate results

Sites scoped ready for selection

Mar 21

Deliverable 2: Obtain agreement with 2-3 facilities to become demonstrator sites

M1.2.1

Site selection

Select 2-3 demonstrator sites to take part in initial set up, make initial contact and establish framework for working

Sites selected and agree to participation

Jun 21

Deliverable 3: Set up the infrastructure at the demonstrator sites

M1.3.1

Set up local site infrastructure

Discuss existing registers, recruitment techniques (including JDR), infrastructure (facilities, SOPs, contracts, consent for contact) and agree data sharing (via DPUK Great Minds)

Establish what is needed to set these up, agree data sharing pathways and complete set up

Dec 21

Deliverable 4: Expand the clinical network to another 4 sites

M1.4.1

Set up infrastructure at another 4 sites

For other sites - discuss existing registers, recruitment techniques (including JDR), infrastructure (facilities, SOPs, contracts, consent for contact) and agree data sharing (via DPUK Great Minds)

Set up complete at an additional site

Jun 22

M1.4.2

Set up complete at an additional site

Dec 22

M1.4.3

Set up complete at an additional site

Jun 23

M1.4.4

Set up complete at an additional site

Dec 23

Deliverable 5: Data collected and shared on recruited participants

M1.5.1

Tools for data collation and selection developed

Tool specification, development, testing, data collation, centralised access.

Tools developed for data retention and selection

Jun 22

M1.5.2

Data collated for recruited participants across network sites and available for selection for targeted recruitment

Participant data available for selection

Sep 22

Deliverable 6: At least one research trial commenced on network participants

M1.6.1

At least one research trial approved to include network participants

Research trial liaison, study development, participant selection and engagement, support for study set up, monitoring of study development, reporting of study results

Research trial approved

Mar 23

M1.6.2

At least one research trial commenced including network participants

Participants selected onto trial from across network sites

Jun 23

 

 

Objective 2: Achieve a consensus on a cognitive screening tool

Specifics

Description

How and who

Outcome

Dates

Deliverable 7: Review and compare the cognitive screening tools used across sites

M2.7.1

Scope cognitive screening tools used across sites

Send scoping questionnaire to all sites & collate results

Sites scoped ready for selection

Mar 22

Deliverable 8: Select a cognitive screening tool to use across the clinical network

M2.8.1

Finalise which cognitive screening tool to use

Discuss with demonstrator sites and review current literature, NHS practices

Confirmation of selected tool

Sep 22

Deliverable 9: Establish the use of the selected cognitive screening tool across the clinical network

M2.9.1

Explore and establish use of cognitive screening tool

Explore ways of establishing use in NHS memory clinics, work with existing infrastructure to set up and agree data sharing

Tools able to be used at sites

Sep 23

Deliverable 10: Cognitive screening tool performance data compared with clinical outcomes across sites

M2.10.1

Cognitive screening tool performance data obtained

Data collection from cognitive screening tool across sites, centralised storage, analysis incorporating clinical outcomes for network participants

Performance data and outcome data obtained and shared

Jun 24

M2.10.2

Cognitive screening tool performance data analysed

Data analysed

Sep 24

M2.10.3

Cognitive screening tool performance data compared with clinical outcomes across sites

Results from data analysis shared

Dec 24

 

 

Objective 3: Collaborate with other similar networks in the UK and internationally to create a wider network for trial delivery

Specifics

Description

How and who

Outcome

Dates

Deliverable 11: Expand the profile of the clinical network

M3.11.1

Expand profile of clinical network and identify collaborations

Explore potential networks for collaborations, logistical and contractual requirements for cross-working

Data gathered on benefits of collaborations and what is needed to set these up

Dec 23

Deliverable 12: Identify and establish collaborations with other memory clinic sites across the UK

M3.12.1

Establish collaborations in the UK

Identify and confirm collaborators in the UK

Collaborative partners agreed

Jun 24

M3.12.2

Meeting of UK collaborative partners held

Sep 24

Deliverable 13: Identify and establish international collaborations

M3.13.1

Establish collaborations internationally

Identify and confirm international collaborators

Collaborative partners agreed

Dec 24

M3.13.2

Meeting of international collaborative partners held

Mar 25

Deliverable 14: Development of agreed best practice from collaborations

M3.14.1

Best practice agreed with collaborators

Identification of key areas of collaboration, discussion of current practices, development of best practice, development of documentation, distribution

Best practice documentation shared

Jun 25

Deliverable 15: Data from network shared across collaboration sites

M3.15.1

Data from network shared across collaboration sites

Data collation, secure centralised storage on DPUK data portal

Data accessible to collaborators

Sep 25

 

 

Objective 4: DPUK/MRC project reporting

Specifics

Description

How and who

Outcome

Dates

Deliverable 16: Produce quarterly reports by the required dates

M4.16.1

Provide Quarterly reports detailing project deliverables and outcomes.

Online quarterly form to be completed for DPUK for MRC meetings

Quarterly report submitted

Mar 21

M4.16.2

Quarterly report submitted

Jun 21

M4.16.3

Quarterly report submitted

Sep 21

M4.16.4

Quarterly report submitted

Mar 22

M4.16.5

Quarterly report submitted

Jun 22

M4.16.6

Quarterly report submitted

Sep 22

M4.16.7

Quarterly report submitted

Mar 23

M4.16.8

Quarterly report submitted

Jun 23

M4.16.9

Quarterly report submitted

Sep 23

M4.16.10

Quarterly report submitted

Mar 24

M4.16.11

Quarterly report submitted

Jun 24

M4.16.12

Quarterly report submitted

Sep 24

M4.16.13

Quarterly report submitted

Mar 25

M4.16.14

Quarterly report submitted

Jun 25

M4.16.15

Quarterly report submitted

Sep 25

Deliverable 17: Produce an annual report by the required dates

M4.17.1

Annual reports to oversee project status and updates of deliverables and outputs. Information to assess completion criteria as part of payment schedule.

Annual form to be completed for DPUK for MRC meetings.

Annual reports submitted to confirm milestone completion for next payment scheduled

Annual report submitted

Dec 21

M4.17.2

Annual report submitted

Dec 22

M4.17.3

Annual report submitted

Dec 23

M4.17.4

Annual report submitted

Dec 24

Deliverable 18: Provide annual financial reporting against the specified budget by the required dates

M4.18.1

Financial reports submitted at the end of each year. Information to assess completion criteria as part of payment schedule.

Yearly financial statement on spending

Financial report submitted

Dec 21

M4.18.2

Financial report submitted

Dec 22

M4.18.3

Financial report submitted

Dec 23

M4.18.4

Financial report submitted

Dec 24

M4.18.5

Financial report submitted

Dec 25

Deliverable 19: Produce a final work package report by the required date to summarise the work completed and the benefits achieved

M4.19.1

Final report submitted at end of project.

PI to complete final report and send to DPUK /MRC for final payment to be made.

Final report submitted

Dec 25