1. Pathway Planning – a model for study initiation or troubleshooting

2. Purpose of the session Background Purpose of bringing to CLG Overview of materials Plans for breakout session

3. Background Training materials were devised following 2007 NCRN Road-shows Delivered through regional model Workshop Format – facilitated

4. Purpose of bringing to CLG Training materials currently delivered by Local Cancer Research Network Managers/Training Links Offered to NIHR Clinical Research Network as part of suite of training materials Needs to be developed further to make more ‘deliverable’ by others Supporting examples give it patient focus, but lacking in materials (mostly in our heads!)

5. Overview of materials Workshop Format –To provide delegates with the opportunity to use pathway planning as part of study initiation or troubleshooting –Interactive –Thought-provoking

6. Topics to be covered National policy that influences pathways Factors that influence timings Patient pathways Critical path

7. Pathway Planning – where can it be used? Recruitment –Increase recruitment by reducing factors that result in ‘missed’ or ineligible patients (better study initiation or troubleshooting) –Attributing recruitment - ‘sharing’ recruitment count Costing studies Governance –PICs, standard care at other sites, accurate completion of SSI

8. Pathway Planning- when can it be used? –Early in study development Development by CI and Study team Maximum impact –Local site during set up implementation Development by PI and support team When should it be used –Both the above! All studies that involve a change in patient’s journey Particularly when the study involves new teams

9. Overview of materials What it is not –Disease pathway Neo-adjuvant, adjuvant etc. Gives context to participants (rules) –Cancer waiting times –NICE IOGs

10. What is a patient pathway? Series of slides from NHS Improvement Focus on –good communication/relationships –Knowing the current pathway –Looking for changes for trial pathway –Look for bottlenecks or critical steps

12. Exploring differences in pathways [ based on trial schedule of events]

13. Identifying patient and before prior interview Pt identified at MDT Pt attends clinic Who will tell the research nurse? How will the PI know when pt is attending clinic? Who will ensure PIS and consent form is clinic? Are there any test results ‘due to expire’? Are there any tests necessary to determine eligibility? When does treatment need to start? Waiting times? Protocol? 1 day Who identifies patient as potentially eligible?

14. Consent Process Where will the patient be? Do we need to change where the patient is? Who will approach the patient?

15. Pathway planning in practice POETIC Study –Co-ordinated by Institute of Clinical Research Clinical Trials and Statistics Unit –Very detailed pathway planning involving cancer patients, trials team and multiple individuals from a variety of disciplines. –Sample of the POETIC pathway and how it has been used to set up the study and address issues, (both national and local), as they have become apparent.

16. POETIC – ICR-CTSU Trial design 1 st follow up visit post-surgery Postmenopausal women with ER/PR positive invasive breast cancer 2 weeks preoperative treatment with AI SURGERY Continue AI for 2 weeks post- operatively No perioperative treatment SURGERY 2 1 Patient pathway Take cores for diagnosis + research cores Hormone sensitive breast cancer diagnosed Patient consents to POETIC 1 st blood sample 2 nd blood sample SURGERY Research core at surgery 1 st follow up after surgery – 3 rd blood sample Patient presents with breast lump Patient asked to donate research core biopsies RANDOMISE 2:1 Postmenopausal women with palpable tumour or ≥1.5cm ultrasound

17. Workshop Group exercises designed to make participants think about study in greater detail Involves lots of post-it notes

18. Break-out session Training itself is patient focused but materials perhaps do not reflect this! Narrative is quite different to the delivery of power point presentation. Application Knowledge Tools Support

19. Break-out session Examples of where your involvement in study design has changed the study Examples of studies using the pathway model Do you have experiences that can be used as examples Need for different examples of ineligible patients

20. Break-out session Having seen the materials is this what you were expecting from the title? What improvements would you want to see? What value language would you add?

21. Break-out session Go, muse, discuss and make notes Reconvene at 14:45

22. Feedback

23. Next steps Revise materials Test at next training session Provide updated materials to NIHR CRN team

24. Thank you! Jackie Sears Jackie.Sears@uhb.nhs.uk Gina Dutton G.Dutton@ncrn.org.uk