How to get support with clinical research studies Clinical Research Network East Midlands How to get support with clinical research studies Chris Siewierski, Study Support Manager – Mental Health, Community and Independent Providers of NHS Services Ruth Robinson, Study Support Service Facilitator, Mental Health, Community and Independent Providers of NHS Services CRN East Midlands RR University of Leicester Venue: George Davies Centre, University Road, Leicester, LE1 7RH 19th March 2018
Core elements of the service The Early Contact Service The Early Contact Service is the first stop on the Research Delivery pathway in the Study Support Service. It provides advice, support and direction for Chief Investigators, Sponsors, and their study teams about how the NIHR CRN can support them to deliver their study to Time and Target. Early Feedback Service and Site Identification Service Gathering intelligence within the East Midlands relating to participant recruitment, potential participating sites and support available Study Delivery Assessment (non commercial) / Site Intelligence (commercial) An assessment for all portfolio studies, undertaken by the network for the network. The outcome of this assessment is to identify challenges to study delivery. Effective Study Start-Up Plan Recommendations to overcome challenges identified earlier on in the research pathway Performance Monitoring Monitors the impact of the recommendations on study recruitment and delivery. Identifies studies requiring additional support to maintain delivery to Time and Target. CS
What is the CRN Study Support Service? The CRN Study Support Service supports researchers from the research idea stage, through the whole research delivery pathway, up until study closure This is not a new service - but streamlining what we already do nationally and locally The service is being implemented across England in all Local Clinical Research Networks (LCRNs) to ensure greater consistency to researchers Regardless of the topic of research or location, researchers will receive the same level of support RR
Early Contact and Engagement CS
How do we engage with researchers? Research Idea Stage Study Development and Planning Face to Face meetings (when possible) to discuss their idea or proposal Working in collaboration with the Research Design Service, CLAHRC, Clinical Trials Units, NHS Research and Innovation (R&I), academic institutions, non-NHS stakeholders, Public Health and community pharmacies Creation and coordination of the study record management Initial advice and guidance on undertaking clinical research within the NHS and what the Study Support Service is Attribution of costs according to AcoRD Guidance Delivering AcoRD training to researchers and study teams Discussions on NIHR Portfolio eligibility criteria and process Issuing Letters of Support as the Lead LCRN to include in funding application Face to Face meetings (when possible) to discuss their study Continued guidance on the Study Support Service and how your research can be delivered in the NHS Continue to work in collaboration with all NHS and non-NHS partners Discussions and support on NIHR Portfolio eligibility criteria and process Gathering intelligence within the East Midlands relating to participant recruitment, potential participating sites and what support is available for the study Support with the IRAS application for HRA Approval National coordination of study as the Lead LCRN to all participating Local CRNs and Devolved Nations CS
How can Early Contact assist? Common barriers: Researcher has limited time to attribute costs before funding submission Treatment Costs and/or Excess Treatment Costs have not been identified early enough IRAS application submitted to HRA before Portfolio Adoption Form (PAF) Solutions: Researcher/Sponsor/Partner Organisation contacting the Study Support Service ASAP...it is never too early! Meeting and discussion what the Early Contact Service can offer CS
Study Set-up and Start-up RR
Purpose of Effective Study Start-Up Effective Study Start Up pulls together all previously identified study challenges into a single, study-wide action plan detailing recommendations to overcome them and support study delivery to time and target. Consists of: Study Milestone Schedule - a central list of all the sites participating in the study, with key study milestones and targets where applicable. Minimum requirement of the start up plan and uploaded onto CPMS by the Lead CRN Study recommendations - specific to the study, outline the tools to be used to help set up the study at each site to maximise study delivery to time and target. RR
How can Effective Start-up assist? Determines study complexity. Identifies population required. Specifies expertise, equipment & facilities required. Provides explicit timelines. Discussion with other participating LCRNs if multi-site. RR
Actively Optimising performance to recruit to time and target CS
Managing Study Performance All studies, commercial and non-commercial It applies to study-level performance management Local CRNs should continue to manage site level performance according to local processes Performance management approach is determined by the study delivery rating assigned following National Study Delivery Assessment 3 study delivery ratings: – Standard – Enhanced – Bespoke Provides: Clearly defined roles and responsibilities for reviewing performance; Standard review procedures and timescales. Communication and escalation processes to avoid duplication of activity, and promote sharing of information CS
How can Performance Management assist? What barriers you may encounter whilst recruiting to time and target? Commercial Early Closure Competing studies Failed Nationally Delays in setting up the study Failed to deliver where other sites achieved Difficult to recruit to and sites closed early Data discrepancies Investigator left Poor study design Non-Commercial Capacity issues Target set too high Recruitment not uploaded Incorrect data from sites, admin error and narrowly missed target Coordinating Centre data discrepancies RR
Study Support Service solutions: Examples: Capacity issues Research Support Team provided a research nurse for fixed term period Recruitment was not uploaded Portfolio Support Team provided support in upload training Target set too high Research Delivery Manager suggested opening other sites or PIC sites CRN Support Infrastructure, Service Support Costs, Inclusion/ Exclusion criteria, Training (AcoRD and Costing Template Workshops) CS FOAM Trial: Capacity issues, Alison gave a Research Nurse for fixed-term 12 months. Took 6 months for study to get set-up 4D Flow MR Angiography of Abdominal Aortic Aneurysms: Was showing no recruitment. Picked up by portfolio support team during performance management. Upload issues. Provided support in upload training and target met. Mechanisms underlying physiology and pathophysiology of pregnancy Too high a target. CRN communicated that recruitment is dependent on consent not blood samples conducted or other study activities. Suggested opening study at other sites or have PICS.
Useful Contacts The Study Support Service email address is: supportmystudyeastmidlands@nihr.ac.uk Primary Care research - East Midlands wide: Catherine Ashman-Lee – catherine.ashman-lee@nihr.ac.uk (MAT leave) Marie Warrington – marie.warrington@nihr.ac.uk Andrew Skeggs – andrew.skeggs@nihr.ac.uk Mental Health and Community Healthcare Services Research - East Midlands wide: Chris Siewierski - chris.siewierski@nihr.ac.uk Acute and Teaching Hospitals Research: Kiran Mistry – kiran.mistry@nihr.ac.uk CS
Thank you for listening We are happy to answer your questions CS