2. Workstreams
1. Evaluation and set up
2. Context
3. Methodology
4. Patient and Public engagement
5. Asset identification
6. NHS pilot site identification
7. Health informatics
8. Regulatory
9. Reimbursement
10. Retrospective analysis
11. Other?
3. Evaluation and set up
1. Expression of Interest
2. Advisory Group
3. Working Party
4. Communication Materials
5. Work plan
6. Funding
7. Risk management strategy
8. Meetings
9. Legalities
10. Risk sharing agreement
4. Patient and Public engagement
Projects Objectives Potential Funding? Partners
To raise awareness of
the public role in the
current ecosystem and
to mitigate any
1. Public and drug
concerns that public
development and Wellcome Trust AMRC
will be exposed to risk
adaptive licensing
(including personal
information leaking).
This will also support
recruitment.
To ensure fully formed
consent when
Wellcome Trust AMRC
2. Decision Support participating in
Companies Companies
adaptive licensing
study
To ensure that all the
necessary aspects of
impact are captured in
3. Patient Experience ? Oxford Primary Care
the pilot. This has been
identified as inadequate
in current trials.
5. Context
WORKSTREAM OBJECTIVES FUNDING PARTNER OUPTS
To ensure all aspects of Workshop and white
1. Ethics Required Ethox
the pilot are ethical paper
To look at the wider
NHS Workshop and white
implications of system
2. Sustainability Required Sustainability/David paper
development including
Pencheon
economic impact
To examine the legal Required Workshop and white
implications of adaptive paper
3. Legalities licensing. EMA/MHRA/DH
6. Methodology
• IMI 7th call: incorporating real-life clinical data into drug
development
• ‘GetReal’ expression of interest submitted
• MRC engagement
Health Informatics
• To create and implement the Health Informatics that will
be needed to support real-life data collection
• To enable the real-time monitoring to be collected by
clinicians and patients
7. Asset identification
Funding required
Partners: NEWDIGS, ABPI, BIO, NICE, EMA,
MHRA, companies
1. Discussion with EMA/MHRA
2. Call for assets
3. Collate Master list of potential assets
4. First round selection
5. Establish selection criteria
6. Match assets against criteria to select second round
7. Explore first round candidates
8. Workshop first round candidates
9. Final selection
8. Pilot site identification
1. Evaluation criteria
2. Identify potential sites/ lead investigators
3. Identify further requirements
4. Funding
5. Agreements
9. Regulatory
• To identify the regulatory pathway/ requirements to
ensure project aligns
• EMA/MHRA/CAMI
Reimbursement
• To identify the reimbursement pathway/requirements to
ensure project aligns with needs
• Set up infrastructure for real-life data collection
• NICE/DH/NIHR/NHS/CAMI
10. Retrospective analysis
• To explore the impact/potential of AL by simulation
informed by retrospective analysis of potential candidates.
