Improving Access to the NHS

1. Improving Access to the NHS Chris Counsell R&D Manager University Hospital Birmingham NHS R&D Forum Conference 10 May, 2006

2. Talk Outline • R&D Office • Processes • Sponsorship • SSAs • Commercial Studies • R&D budget allocation • Future • Data

3. R&D Office • 2.5 wte personnel • R&D Director – 2 sessions • R&D Manager – 0.5 wte • R&D Administrator – 0.75 wte • Clinical Trials Officer – 1.0 wte • Research Governance Manager – 1.0 wte - post frozen • ~200 studies per year (+50 student)

4. Database • In-house • ‘Management System’ not just Information system • Networked with offline copy • Triggers events • Warns against, and prevents, certain actions • Role specific features • Linked to MS Word – standard letters, MS Outlook – emails, Adobe Acrobat – electronic study files • Linked to other databases – publications, university income, • Picks out keywords in text to characterise study (e.g. CT-IMP, Gene Therapy, involves ionising radiation etc.)

5. R&D Process – Principles • Study registration is the hook • No committee • Not role of R&D office to judge research • Role to coordinate discussion and agreement between PI and relevant services • Not do PI’s job – i.e. do not ‘champion’ the research • Vast majority of research ok – process needs to be able to identify and deal with the few problems • Fit as far as possible with existing processes and procedures within Trust

6. Submission Information • Minimum • Protocol (+ request to start processing) • Provisional approval • Participant Information sheet(s) + sample consent forms • Ethics Parts A,B (& C) • Written evidence of sponsorship (or request for UHB to act as sponsor) • NHS R&D Form (not a requirement) • Full approval • Ethics approval • Regulatory approval

7. Principal Investigator Criteria • For any study that involves intervention in care of patient. PI must: • hold substantive or honorary contract with Trust • be of consultant status or equivalent From October 2006 • have evidence of recent accredited GCP training

8. Approval Processes • 3 different routes • Normal • Most studies, requires local principal investigator (PI) • ‘no objection’ • Has no local PI; declared SSA exempt; makes no use of Trust resources beyond usual care • Student • Approved by student sub-committee of South Birmingham REC

9. Full approval requirements • Sufficient information to register with NRR (non-commercial) • Principal Investigator agreement (or signed NHS R&D Form) • Clinical Director approval (or signed on NHS R&D Form) • No service objections • Sponsorship • Indemnity and contract finalised (for commercial studies) • IRMER 8 form (ionising radiation) • GMSC approved (gene therapy studies) • Treatment continuation (CTIMP) If all met before ethics approval – issue ‘provisional’ approval (and sign contracts) If ethics approved but conditions not met – issue ‘hold’ approval (do not sign contracts) • Ethics approval • MHRA approval (medicines trial) • Confirm full Trust approval

10. ‘No Objection’ Requirements • Sufficient information to register with NRR (non-commercial) • No objection from relevant clinical/service lead • Sponsor identified • Study approved by REC and declared SSA-exempt, or does not require REC approval Condition of approval is that researchers only have limited access to Trust resources

11. Student Studies • Approved by student sub-committee of South Birmingham REC • If research supervisor does not hold contract with Trust, must appoint clinical supervisor who does • Clinical and research supervisors sign acceptance of their roles • Research supervisor accepts sponsorship on behalf of University

12. Full Approval PI R&D Office Clinical Director Pharmacy Service Leads Regulatory checks Dialogue Information approval required/not required

13. Student R&D Office Student Research Supervisor Service Leads Clinical Supervisor Regulatory checks

14. ‘no objection’ R&D Office CI Service /Dept. Head Regulatory checks

15. Process Status 2 months +1 month Registered Abandoned Processing 2 months +1 month Withdraw Provisional Reject Provisional Approval 2 months Full Approval

16. Delays • Clinical Director signature • IRMER • PI not responding / returning documents • Sponsorship • Contract (particularly if not standard mCTA) • Costings

17. Fate of Studies Registered in 2005 Student 39 Registered 239 Abandoned 10 (3 on-going) Other 14 1 not UHBT 1 reject by ethics 12 abandoned by PI/sponsor Abandoned 10 Processing 173 Other 10 2 not UHBT 8 abandoned by PI/sponsor Reinstated 5 (20 on-going) ‘No Objection’ 10 Provisional approval 66 Withdraw provisional 22 Abandoned 5 (6 on-going) (3 on-going) Full approval 62 Confirmed 38 Approved 14

18. Trust Sponsorship • PI must complete sponsor request form • Provisional agreement to act as sponsor dependent on ethics/regulatory approval plus satisfactory funding (if externally funded) • UHB agreed to act as sponsor for 30% of studies registered in 2005. • Of which 90% are single-centre, 5 CTIMPs • Requested ethics to accept UHB sponsorship only if application contains letter from R&D office – not always followed • Site agreements – mainly for multicentre CTIMPs • Chief Investigator agreements – from May 2006

19. Site Specific Assessments (SSAs) • Part Cs submitted to South Birmingham REC • Forwarded to UHB R&D • SSA committee • SBREC Chair + 1 other • R&D Director (SSA Chair), R&D Manager + 1 other • Assessments all by email – return deadline • Require at least 2 responses to Chair for final decision • R&D admin emails decision to SBREC • SBREC updates ethics database

20. SSAs • 164 SSAs Since March 2005 • Median response time 10 working days • Objections raised on 14 studies • Suitability of PI • Suitability of facilities • Use of translation services • Queries raised with main REC

21. Commercial Studies • Contracts and costings handled through R&D Office • Follow NHS R&D Forum costing guidance • Clinical Trials Officer uses protocol and visit grid to draw up first-pass costing • Circulated to all relevant service leads + PI for confirmation • PI agrees final budget with Sponsor (either directly or via R&D) which must cover agreed service costs • Service leads + PI all sign agreements for internal transfer of funds

22. Commercial cont. • All funds paid into named Research Accounts (rules similar to charity accounts – including budget roll-overs) • Internal transfers to service departments • R&D Office Start up fee + 10% of per patient fee • Expect payments on invoices only (PIs learnt the hard way why – money lost in finance)

23. Commercial contracts • Expect sponsors to use model CTA • Pharmacy now included in overall CTA (but can invoice separately) • If use University facilities, required to insert additional clause referencing sub-agreement • University Full Economic Costing significant increase in costs (some trials lost)

24. Commercial Issues • Sponsors requiring unjustified changes to model CTA • CRO/Sponsor not communicating well • CRA trying to sort everything out independently of R&D • Changing contact at sponsor/CRO • Playing PI against R&D

25. NHS R&D Support Funding internal allocation • All projects given a ‘weight’ – minimal, low, standard, high – dependent on strategic factors, not numbers of patients. • R&D Budget 1 allocation divided among clinical departments based on total relative weighting of previous year’s studies • Finance ‘cascade’ model determines allocations to all service departments • R&D budget line at high level only (Divisions and Groups) • Departments not required to reconcile R&D cost to R&D income

26. Future • Web-based application process • Better link to other Trust & University databases (HR, Finance) • Link with external systems (Ethics, Funders, Regulators, Clinical Trials Registers etc.) • Paperless processing

27. Post approval • Audit • Annual reports • Adverse event reporting • Amendments

28. Study Numbers

29. Approval Times