1. NIHR Research Design Service (NE) Research Design Services & Clinical Trials Units Professor Elaine McColl Director Newcastle CTU and NIHR RDS (NE)

2. NIHR Research Design Service (NE) “The NIHR RDS should offer advice and guidance on all aspects of research design and conduct including: –formulating research questions… –research design for quantitative studies… –research design for qualitative studies… –identifying and applying to appropriate funding sources… –contacting appropriate collaborators in research… “Each RDS must at its core have access to health economic and statistical expertise, systematic review and research methodological expertise, and be able to draw on other expertise as necessary to provide guidance on the range of topics indicated above.” The services offered by RDSs

3. NIHR Research Design Service (NE) Clinical Trials Units Clinical Trials Units (CTUs) are specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies.

4. NIHR Research Design Service (NE) Range of models in existence –Formal relationships (not mutually exclusive) Local CTU(s) co-applicant on the RDS bid Geographical co-location of CTU and RDS (hub) Shared staff between RDS and CTU Local RDSs (in previous guise of RDSU) and their staff named in applications for UKCRC CTU registration –Informal relationships Cross-referral in both directtions between RDS and CTUs in region –No formal relationship no or few CTUs in some regions recognised as a gap and working to fill this gap The relationship between RDSs & CTUs

5. NIHR Research Design Service (NE) Expertise in trial design & statistics –All RDSs have this expertise in-house (though sometimes in guise of generalist statisticians rather than ‘triallists’ per se) Expertise in ‘practical’ aspects of trial conduct (recruitment strategies, EU CT Directive, ethics) –Not all RDSs have this expertise in-house RDSs’ Expertise in Trials

6. NIHR Research Design Service (NE) Cross-referral happens both ways – RDS to CTU and CTU to RDS A range of models are in existence –Refer onwards as soon as RDS is confident that an RCT is the correct methodology –May ‘bring in’ CTU rather than refer on (i.e. RDS maintains some involvement) –Can depend on geographical location and/or nature of proposed trial –Don’t currently refer onwards to a CTU –Shared staff and therefore collaborative approach with possible co-badging of the study How and when do RDSs refer to CTUs

7. NIHR Research Design Service (NE) Areas with no RDSs, others with no/few/only specialist CTUs –RDSs work within region, CTUs may work across country Capacity issues for both RDSs and CTUs –Competing deadlines “ Incentives” for both RDSs and CTUs to seek the work, as both judged on applications supported From a cost point of view, incentive to investigators to go to RDSs NETSCC funders ask about engagement with registered CTU, providing an incentive to engage with CTU at application stage RDS remit (largely) stops when funding obtained Challenges of RDS and CTU cross-working - 1

8. NIHR Research Design Service (NE) Investigators being confused about where to go and when –Need for clear sign-posting: perhaps start with RDS Risk of inconsistent advice being given by RDS and CTU –Timing of referral crucial here Greater difficulty in synergistic working with geographical separation –Funding (inc. capital) to facilitate closer working Challenges of RDS and CTU cross-working - 2