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Work Package 23 a&b: Precision Pre-clinical Recruitment

PI/Lead: Ivan Koychev, Oxford, DPUK Clinical Scientist

Start date:  Jan 2021                                                                                                                  End date: Dec 2025

Objective of project

The Trials Delivery Framework (TDF) will create an integrated, high quality, experimental medicine focused, national trial delivery network. This will include research registers for precision recruitment for pre-clinical studies, standard clinical assessment for recruitment to early clinical studies, and a network of clinical facilities accredited for multi-centre studies. The TDF builds on earlier work by DPUK including the DPUK imaging, stem cell, and informatics networks. These networks provide national reach for multi-centre studies. The TDF comprises two integrated work packages, each designed to fill important gaps in the UK trials ecosystem.

 

Background

Lack of success in dementia clinical trials is in part a result of the heterogeneity of research participants and poor characterisation. This is a particular problem for early disease stage, pre-clinical experimental medicine studies. Two research register, each providing different levels of characterisation have been established to address this with current work focussing on developing efficient study enrolment procedures.

 

Aim

To provide risk stratified recruitment for preclinical dementia experimental medicine studies and pre-clinical trial studies.

 

Work Package 23a: The Clinical Studies Register (CSR)

(n=53,528 as of December 2020) is a re-contact platform for DPUK cohort participants who already have a consent to re-contact on the basis of their existing cohort data. It currently consists of members from the Airwave and HealthWise Wales cohorts and includes data on the participants’ health (n=47k), cognitive phenotyping (n=34k) and GWAS (n=21k). This resource is able to support a range of studies that require stratified recruitment and offers a level of precision based on single alleles (e.g., APOE), polygenic risk, cognition and lifestyle. The Clinical Studies Register will be developed further and promoted to ensure incremental utilisation.

 

Work Package 23b: The Great Minds Register (GM)

(n=4,542 as of December 2020) is a solution for individuals who have provided explicit consent for re-contact on the basis of their risk of dementia, as determined by serial cognitive assessments and self-reported medical data relevant to trial inclusion. Procedures are in place to allow remote genetic testing and actigraphy-based monitoring.  At December 2020, the Great Minds Register has 4,542 members available from 6 platform cohorts: HealthWise Wales, Airwave, Brains for Dementia Research (BDR), SleepQuest, Aberdeen Cohort of the 1950s and European Prevention of Alzheimer’s Disease (EPAD), of which 4,530 have health data and 2,725 have cognitive data.  The Great Minds Register will be developed further and promoted to ensure incremental utilisation.  Regular engagement with participants will be continued and developed based upon participant feedback.

 

Objective 1: Develop and promote the Clinical Studies Register (CSR) (work package 23a)

Deliverable 1: Increase the number of cohorts providing participants into the CSR by at least one per annum.

Deliverable 2: At least two new studies per annum utilise the CSR for recruitment.

Deliverable 3: The CSR database is enhanced to incorporate additional variables to enhance selection capabilities.

Deliverable 4: Re-develop the CSR feasibility tool to provide additional functionality for researchers.

 

Objective 2: Develop and promote the Great Minds Register (GM) (work package 23b)

Deliverable 5: Increase the number of participants registered on Great Minds to a target of 8,000.

Deliverable 6: At least three new studies per annum use Great Minds for recruitment.

Deliverable 7: The Great Minds database is enhanced to incorporate additional variables to enhance selection capabilities.

Deliverable 8: Determine genotypes for 50% of Great Minds participants and add to database to enhance selection capabilities.

Deliverable 9: Re-develop the Great Minds feasibility tool to provide additional functionality for researchers.

 

Objective 3: Continue and enhance the engagement with participants of the registers

Deliverable 10: Organise and run at least two engagement events every year to which all participants are invited.

Deliverable 11: Develop the website to provide Great Minds participants with additional, relevant information.

Deliverable 12: Solicit feedback from participants on the value to them of the engagement events and information provided on the website to enable further development.

 

Objective 4: DPUK/MRC project reporting

Deliverable 13: Produce quarterly reports by the required dates.

Deliverable 14: Produce an annual report by the required dates.

Deliverable 15: Provide annual financial reporting against the specified budget by the required dates.

Deliverable 16: Produce a final work package report by the required date to summarise the work completed and the benefits achieved.

 

 

 

 

Objective 1: Develop and promote the Clinical Studies Register (CSR) (work package 23a)

Specifics

Description

How and who

Outcome

Dates

Deliverable 1: Increase the number of cohorts providing participants into the CSR by at least two per annum

M1.1.1

At least one additional cohort providing participants each year

GM/CSR Team.  Engagement with platform cohorts, contract agreement, data transfer, database incorporation, transfer onto selection tools

Number of additional cohorts providing participants into CSR

Dec 2021

M1.1.2

Number of additional cohorts providing participants into CSR

Dec 2022

M1.1.3

Number of additional cohorts providing participants into CSR

Dec 2023

M1.1.4

Number of additional cohorts providing participants into CSR

Dec 2024

M1.1.5

Number of additional cohorts providing participants into CSR

Dec 2025

Deliverable 2: At least two new studies per annum utilise the CSR for recruitment

M1.2.1

Increase the number of studies using CSR participants by at least 2 per annum

GM/CSR Team.  Liaison, promotion of service, study development, participant selection and engagement, support for study set up, monitoring of study development, reporting of study results

Number of new studies recruiting or ongoing

Dec 2021

M1.2.2

Number of new studies recruiting or ongoing

Dec 2022

M1.2.3

Number of new studies recruiting or ongoing

Dec 2023

M1.2.4

Number of new studies recruiting or ongoing

Dec 2024

M1.2.5

Number of new studies recruiting or ongoing

Dec 2025

Deliverable 3: The CSR database is enhanced to incorporate additional variables to enhance selection capabilities

M1.3.1

At least one incremental variable incorporated within each year

GM/CSR Team.  Engagement to identify variables, liaison with cohorts to confirm availability, data transfer, data harmonisation, inclusion into database, transfer onto selection tools

Number of additional variables added for selection

Dec 2021

M1.3.2

Number of additional variables added for selection

Dec 2022

M1.3.3

Number of additional variables added for selection

Dec 2023

M1.3.4

Number of additional variables added for selection

Dec 2024

M1.3.5

Number of additional variables added for selection

Dec 2025

Deliverable 4: Re-develop the CSR feasibility tool to provide additional functionality for researchers

M1.4.1

Re-develop the CSR Feasibility tool on superior technology to provide additional selection capabilities for researchers

GM/CSR Team.  Obtain feedback from researchers on current tool relative to requirements, specify tool requirements, develop tools, demonstrate enhanced tools, and obtain additional feedback.

CSR Feasibility tool re-developed to better meet researchers’ requirements.

Jun 2022

 

Objective 2: Develop and promote the Great Minds Register (GM) (work package 23b)

Specifics

Description

 How and who

Outcome

Dates

Deliverable 5: Increase the number of participants registered on Great Minds to 8,000

M2.5.1

Number of participants on the Great Minds Register increased each year to achieve a target of 8,000 participants by December 2025

GM/CSR Team.  Engagement with platform cohorts, contract agreement, unique ID development, participant engagement and invitation, participant registration, cohort data transfer, database incorporation, transfer onto selection tools

 

Incremental participant membership

Dec 2021

M2.5.2

Incremental participant membership

Dec 2022

M2.5.3

Incremental participant membership

Dec 2023

M2.5.4

Incremental participant membership

Dec 2024

M2.5.5

Incremental participant membership

Dec 2025

Deliverable 6: At least three new studies per annum use Great Minds for recruitment

M2.6.1

Increase the number of studies using Great Minds participants by at least 2 per annum

GM/CSR Team.  Liaison, promotion of service, study development, participant selection and engagement, support for study set up, monitoring of study development, reporting of study results

Number of new studies recruiting or ongoing

Dec 2021

M2.6.2

Number of new studies recruiting or ongoing

Dec 2022

M2.6.3

Number of new studies recruiting or ongoing

Dec 2023

M2.6.4

Number of new studies recruiting or ongoing

Dec 2024

M2.6.5

Number of new studies recruiting or ongoing

Dec 2025

Deliverable 7: The Great Minds database is enhanced to incorporate new cohort variables to enhance selection capabilities every year

M2.7.1

At least two incremental variables incorporated within each year

GM/CSR Team.  Engagement to identify variables, liaison with cohorts to confirm availability, data transfer, data harmonisation, inclusion into database, transfer onto selection tools

Additional selection variables added to database and selection tools

Dec 2021

M2.7.2

Additional selection variables added to database and selection tools

Dec 2022

M2.7.3

Additional selection variables added to database and selection tools

Dec 2023

M2.7.4

Additional selection variables added to database and selection tools

Dec 2024

M2.7.5

Additional selection variables added to database and selection tools

Dec 2025

Deliverable 8: Determine genotypes for 50% of Great Minds participants and add to database to enhance selection capabilities

M2.8.1

Genotype samples from at least 50% of GM participants and include the results in the database and selection tools so that they are available as selection capabilities for researchers

GM/CSR Team.  Send kits to consented participants, perform genotyping, obtain results and incorporate into database and selection tools.

Number of participants with genotypes available for selection in GM studies.

Dec 2023

Deliverable 9: Re-develop the Great Minds feasibility tool to provide additional functionality for researchers

M2.9.1

Re-develop the GM Feasibility tool on superior technology to provide additional selection capabilities for researchers

GM/CSR Team.  Obtain feedback from researchers on current tool relative to requirements, specify tool requirements, develop tools, demonstrate enhanced tools and obtain additional feedback.

GM Feasibility tool re-developed to better meet researchers’ requirements.

Jun 2023

 

Objective 3: Continue and enhance the engagement with participants of the registers

Specifics

Description

 How and who

Outcome

Dates

Deliverable 10: Organise and run at least two engagement events every year to which all participants are invited

M3.10.1

Hold a member event in every six-month period

GM/CSR Team, Communications.  Determine appropriate brain health topic, identify suitable researchers, organise event, invite participants, host event, evaluate.

Member event held & evaluated

Jun 2021

M3.10.2

Member event held & evaluated

Dec 2021

M3.10.3

Member event held & evaluated

Jun 2022

M3.10.4

Member event held & evaluated

Dec 2022

M3.10.5

Member event held & evaluated

Jun 2023

M3.10.6

Member event held & evaluated

Dec 2023

M3.10.7

Member event held & evaluated

Jun 2024

M3.10.8

Member event held & evaluated

Dec 2024

M3.10.9

Member event held & evaluated

Jun 2025

M3.10.10

Member event held & evaluated

Dec 2025

Deliverable 11: Develop the website to provide Great Minds participants with additional, relevant information

M3.11.1

Review and develop website

GM/CSR Team, Communications.  Review of website, develop additional content, develop design.

Website re-developed

Dec 2021

M3.11.2

Website re-developed

Dec 2023

Deliverable 12: Solicit feedback from participants on the value to them of the engagement events and information provided on the website to enable further development

M3.12.1

Generate input from participants on the value of member events and the website through questionnaires and follow-up conversations.

GM/CSR Team, Communications.  Development of questionnaires, delivery of questionnaires, review and analysis of responses, plan follow-up conversations, review, determine required developments.

Feedback obtained and incorporated

Dec 2022

M3.12.2

Feedback obtained and incorporated

Dec 2024

 

Objective 4: DPUK/MRC project reporting

Specifics

Description

 How and who

Outcome

Dates

Deliverable 13: Produce quarterly reports by the required dates

M4.13.1

Provide Quarterly reports detailing project deliverables and outcomes.

Online quarterly form to be completed for DPUK for MRC meetings

Quarterly report submitted

Mar 2021

M4.13.2

Quarterly report submitted

Jun 2021

M4.13.3

Quarterly report submitted

Sep 2021

M4.13.4

Quarterly report submitted

Mar 2022

M4.13.5

Quarterly report submitted

Jun 2022

M4.13.6

Quarterly report submitted

Sep 2022

M4.13.7

Quarterly report submitted

Mar 2023

M4.13.8

Quarterly report submitted

Jun 2023

M4.13.9

Quarterly report submitted

Sep 2023

M4.13.10

Quarterly report submitted

Mar 2024

M4.13.11

Quarterly report submitted

Jun 2024

M4.13.12

Quarterly report submitted

Sep 2024

M4.13.13

Quarterly report submitted

Mar 2025

M4.13.14

Quarterly report submitted

Jun 2025

M4.13.15

Quarterly report submitted

Sep 2025

Deliverable 14: Produce an annual report by the required dates

M4.14.1

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 2021

M4.14.2

Annual report submitted

Dec 2022

M4.14.3

Annual report submitted

Dec 2023

M4.14.4

Annual report submitted

Dec 2024

Deliverable 15: Provide annual financial reporting against the specified budget by the required dates

M4.15.1

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 2021

M4.15.2

Financial report submitted

Dec 2022

M4.15.3

Financial report submitted

Dec 2023

M4.15.4

Financial report submitted

Dec 2024

M4.15.5

Financial report submitted

Dec 2025

Deliverable 16: Produce a final work package report by the required date to summarise the work completed and the benefits achieved

M4.16.1

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 2025