Transcript presentation for commercial customers

NHS Research Scotland
- Overview
- Feasibility
- R&D permissions
Dr Alison Walker
National Coordinator,
NRS Permissions CC
Commercial presentation
NHS Research Scotland (NRS)
• Collaboration
– CSO
– 14 NHS Boards in Scotland
• Funding
– CSO and Scottish Enterprise
• Function
– coordinate R&D processes and
systems
‘..agree and implement national policy to deliver greater
efficiency in the NHS R&D and Research Ethics function’
More efficient and effective service for Pharma
CSO – Chief Scientist office
NRS – ‘hub & spokes’
• Four regional hubs
–NRS N (NHS Grampian)
NRS PCC
• NRS Permissions CC
NRS N
–NRS SW (NHS GG&C)
• IT systems lead (SReDA)
–NRS SE (NHS Lothian)
• Contracts
• National training
NRS E
NRS SW
–NRS E (NHS Tayside)
• Governance
NRS W
NRS SE
Regional arrangements deliver coordinated systems to
facilitate clinical research
NRS PCC – NRS Permissions Coordinating Centre
NHS GG&G – NHS Greater Glasgow & Clyde
NRS Permissions CC
• Dedicated administrative team
• Coordination
– Feasibility
– Master CDAs
– R&D permissions process for multicentre1 studies
• Single point of contact
• Contact point for rest of UK – link with other
coordinated systems:- eg. CSP Unit, NISCHR PCU
Streamlined process to obtain R&D permission for
multicentre research in Scotland
1
Multicentre = > 1 Health Board/Trust in UK
CDAs – Confidential Disclosure Agreements
NRS Permissions CC – the team
• Director
– Professor David Reid
• National Co-ordinator
– Dr Alison Walker
• Senior Administrators
– Pamela Shand
– Karen Innes
• Administrator
– Lindsay Grant
Processes managed by NRS Permissions CC
•
Feasibility in Scotland
•
Coordination of R&D permissions process
•
Amendments
•
Addition of new sites
Feasibility in Scotland
• No formal ‘adoption’ process in Scotland
• Feasibility request/questionnaire/CDA sent to Permissions CC
• Permissions CC forwards study information to:• R&D commercial managers/facilitators (agreed Health Boards)
• Scottish Clinical Specialty Lead (if applicable)
• Scottish Topic-Specific Research Network Managers
• Investigators approached/supported to participate
• 2 week deadline for response
• Permissions CC actively chases / feeds back to Industry
• Companies are put directly in touch with interested parties to take
discussions forward
• At least involve NHS R&D commercial managers
Scotland: therapeutic areas of expertise
• Cardiovascular Disease
 Dermatology
• Gastrointestinal Disease
 Infectious Disease
• Inflammation/Immunology
 Metabolic Disease/Diabetes
• Neuroscience
 Oncology
• Opthalmology
 Mental Health
• Respiratory Disease
 Stroke
• Tissue Research
 Women’s Health
• Extensive imaging infrastructure and latest biomedical NMR
imaging techniques
• Scottish Clinical Specialty Lead represented on UKCRN/NIHR
Specialty Groups
• Topic-Specific Research Networks eg. Diabetes, Mental Health,
Dementia, Cancer, Stroke, Medicines for Children, Primary Care
When to use NRS Permissions CC
• More than one Board/Trust within UK
– Regardless of adoption in England
– Regardless of use of CSP, etc.
• Only time NRS Permissions CC is not used is
for SINGLE SITE IN UK studies
R&D Permissions Process Overview
‘Full Document Set’
0d
NRS Permissions CC
Each Health Board
Generic Review
Local Review
Certificate of Compliance
Local Management
Permission
Time
Lead Health Board
30d
NRS R&D Permission Process(es)
R&D permissions process in Scotland is
simple, but can vary depending on:•
single- or multicentre?
•
UK-wide study?
•
lead R&D office?
UK-wide study (lead R&D office in Scotland)
Applicant notifies Permissions CC of UK-wide multicentre project
Permissions CC sends applicant ‘Document Submission Checklist’
Confidentiality Agreements as required
Applicant sends IRAS R&D application to Permissions CC;
and IRAS SSI Forms to PIs (UK-wide)
Permissions CC uploads documents to SReDA; notifies participating Scottish
R&D office(s); requests outstanding documents; assigns lead reviewer
Permissions CC emails IRAS
R&D Form to other UK
nation(s)
Permissions CC emails
global documents to other
UK nation(s)
Generic Review
Local Review(s)
Scottish sites
Certificate
of Compliance (CofC)
Permissions CC emails CofC
to other UK nation(s)
For each Scottish Health Board:
Local management permission letter
Permissions CC will confirm when we have a full document set
SSI Form
R&D application to Permissions CC / SSI Forms to PIs
• Email documents to [email protected]
• Minimum for Permissions CC to assign generic reviewer:• confirmation of Health Boards/sites
• protocol + Costing Template + draft contract
• Can submit prior to receiving Ethics/MHRA approval
• Employ UK CRN Industry Costing Template
• Scottish model contract, draft:
mCTA, mCIA, mCTA-CRO, mCIA-CRO
Budget and Contract
• Budget
–UK CRN Industry costing template
• PbR MFF Scotland = 1.2; (negotiable for smaller Boards)
–Generic review
• Accuracy; Per patient fee; Additional costs
–Local review
• Board specific requirements
• Contracts
–ABPI mCTA – SCOTLAND 2011
–Generic review
• Final template for Scotland
–Local
• Board specific requirements
UK CRN – UK Clinical Research Network
PbR MFF – Payment by Results Market Forces
Factor
mCTA – model Clinical Trial Agreement
Scotland wide set up fees
Type of fee
Cost (inc. PbR MFF)
R&D set up fee
£840 (As per costing template)
Pharmacy set up fee
Dependent on study type
as per costing template
Site set up fee
£500 Observational
£1000 Phase 3/4
£1500 Phase 1/2 or GM
ARSAC
£500
inc Local Med Phys Expert
Archiving fee (per box)
£300
PbR MFF = Payment by Results Market Forces Factor
GM = Genetically Modified
UK-wide study (lead R&D office in other UK nation)
Applicant submits R&D application to other UK nation eg. to NIHR CSP Unit via IRAS
CSP Unit forwards IRAS R&D Form promptly to Permissions CC, along with global documents available
at that time
Lead CLRN collates global
documents and carries out global
governance checks
If ‘No’
Permissions CC contacts study contact promptly to
recommend submitting to Scotland (via Permissions CC)
in parallel, as well as remind about Scottish SSI Forms for
local Scottish PI(s)
If ‘Yes’
Permissions CC waits for global
documents and Governance Report from
Lead CLRN
Follow process as if lead R&D office is in Scotland
Mini-generic
Review for
Scotland
[no documents/CofC need be forwarded
Local Review(s)
Scottish sites
to other UK nation(s)]
Certificate of
Compliance
For each Scottish Health Board: Local management permission letter
How you can help speed up the process ?
•
•
•
•
Apply for R&D permission prior to receiving REC/MHRA approval
Documents you send to a REC, send also to Permissions CC (incl. interim)
Use the NRS Document Submission Checklist
Send correct versions of necessary documents to NRS Permissions CC
electronically
• Employ Scottish model contracts “as published”
• Obtain PIs’ support prior to sending out Site-Specific Information (SSI)
Forms and let them know that the SSI Form is on it’s way
• Submit amendments sent to a REC to NRS Permissions CC also, and at the
same time
Commercial customers should also:• Employ the UK CRN Costing Template
• Get in touch with NRS Permissions CC early to discuss CDAs
• Get in touch early on to initiate contract / budget discussions with the
Commercial Manager of the lead R&D office
Processes for: Amendments, New Sites
Amendments
• Permissions CC coordinates amendments for NRS projects
• Permissions CC should receive documentation, to upload
and notify participating Health Boards / other UK nation
New sites
• Adding new Scottish site to Scottish multicentre study, post
R&D permission
• Adding new Scottish site to single-Scottish-site study, post
R&D permission
• Adding 1st Scottish site to UK study
Submit
information
only once to
Scotland
Single point of
entry for
multicentre
permission
applications
No
adoption
process
One source
of requests
for global
documents
One source of studywide project queries
We can put you in touch
with the right people
Centralised
project
coordination and
management
Benefits of using
NRS
Permissions
CC
NRS R&D permissions
performance oversight
Efficient
addition
of new
sites
Escalation
NRS
teleconferences
Coordination of
amendments
Project Alert
Reports
Work Area
Alerts
Project
tracking:
adherence to
target
timelines
Improved
efficiency –
reduced
duplication
Active project management
• Circulation of ‘Project Alert Report’ every 2 weeks
• NRS teleconference every 2 weeks, to discuss projects with key
R&D office staff from each Node - chaired by Permissions CC,
representation from CSO
• Permissions CC team chases updates / actions / resolution
• Escalation procedure
• SReDA ‘Work Area’ alerts – at 20 and 30 calendar days
How is Scotland performing?
NRS R&D permission times measured from:receipt of NRS full document set, to issue of local Management
permission at each participating Health Board R&D office
[as ‘Net NHS time’].
NRS Performance Metrics – commercial
Commercial studies: R&D permission times (Jan 10-Jun 12)
R&D permission time (working days)
Median
30
Mean
22
21
20
18
19
19
16
20
18
16
18
18
16
10
0
Jan-Jun 10 Jul-Dec10 Jan-Jun 11 Jul-Dec 11 Jan-Mar 12 Apr-Jun 12
Time period
Commercial project stats
Commercial clients to date - 112 Pharmaceutical / Device companies
44 Clinical Research Organisations
No. of projects received to date: 347
65% of studies use only 1 Scottish site
Feasibilities conducted via NRS Permissions CC: 138
• 41 through NRS-PPD alliance
• 12 through NRS-Quintiles Prime Site alliance
• 85 direct from Pharma
No. of feedback questionnaires received = 66
Unacceptable
Poor
Acceptable
Availability (NRS PCC personnel)?
Competence (NRS PCC personnel)?
1
Helpfulness/attitude/flexibility?
Overall experience of the process?
1
Good
Excellent
3
26
35
4
29
30
1
21
41
6
28
30
Ongoing/Future plans
• Website update
– Link with Health Sciences
Scotland
• Improve feasibility
– Commercial Facilitators
• R&D involvement in
Site Initiation Visit
• Pharmacy Working
Group
• Patient databases
• Capability statements
• Communication Plan
• Collection of agreed
metrics
• Actively manage
recruitment
• Pharma/CRO and R&D
Collaboration
– Recruitment/troubleshooting
• Agreed Scotland wide
set up fees
Supporting clinical studies
•
Commercial Facilitators
– 2 in each node (primary and secondary care)
– Assist with feasibility, start up and recruitment
• Nurses
– Dedicated research nurses
– Help with resourcing nurses
– Expert support for investigators
• Imaging infrastructure
– Dedicated scanners and reporting
NRS Permissions CC Contact details
Dr Alison Walker
National Coordinator
NHS Research Scotland Permissions Coordinating Centre
(NRS Permissions CC)
[email protected]
Tel: 01224 554051
NRS Permissions CC Office
[email protected]
Tel: 01224 552690
Website: http://www.NRSPCC.org
Health Science Scotland
Health Science Scotland is uniquely placed to set up
collaborations between companies and researchers.
Graeme Boyle: Senior Program Manager
[email protected]
www.healthsciencescotland.com
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