Delivering clinical research to make patients, and the NHS, better Head & Neck Cancer Research Report Site Specific Group Meeting Tuesday 9 th June 2015 Maxine Taylor Senior Research Delivery Manager

Content of report Overview of network changes Overview of research activity New studies for the portfolio Request for research lead 2

Introduction NIHR Clinical Research Network merged all cancer research networks with all other clinical research networks in England on 1 st April 2014 CRN - West of England is one of 15 new networks This new geography does not map exactly to the site specific group geography. It now includes Gloucestershire and Swindon but no longer includes Taunton and Yeovil Taunton and Yeovil are served by the CRN – South West Peninsula I will work closely with my counterpart in South West Peninsula to support this SSG in full 3

West of England Population 2.4 million - Budget £13.2 million - 7 Acute Trusts - 2 Mental Health Trusts - CCL Principal Treatment Centre - Full team only since December Small core support team based at host in Bristol Research will follow patient pathways regardless of network geography Map showing the 15 Clinical Research Networks in England

Purpose of the network Translation of national workstreams and objectives (generic and specialty specific) with strategic oversight of research activity within the geography of CRN - West of England in terms of: –Portfolio Balance, new studies, feasibility, industry trials –Performance Targets, support timely set up, support timely recruitment –People Skill mix, workforce flexibility, resources, training 5

CRN - West of England Management Model Division s 2 & 6 Division s 3 & 4 Division 5 Division 1 Maxine Taylor Senior RDM Workforce Development Mary Griffin RDM RM&G and Industry Ruth Allen RDM Business Intelligence Chantal Sunter RDM Patients & Public & Communications Mary Perkins Chief Operating Officer

Network Clinical Divisions Cancer Division 1 DiabetesRenal StrokeMetabolic & endocrine Cardiovascular Division 2 ChildrenReproductive health & childbirth GeneticsHaematology Division 3 Mental Health Dementias & neurodegenerative diseases Neurology Division 4 Primary careAgeingHealth services research Oral & dentalDermatology MusculoskeletalPublic Health Division 5 ENTAnaesthesia & pain management SurgeryCritical care RespiratoryOpthalmology Critical careInfectious diseases HepatologyGastroenterology Division 6

The Clinical Team Dr Steve Falk Clinical Director 6 Divisional Clinical Leads Prof Hugh Barr for Div 1 30 Specialty Leads Sub Specialty Leads Sue Taylor Network Consultant Nurse Clinical Research Teams

NIHR CRN High Level Objectives Set up as fast as you can Recruit as many and as fast as you can All organisations involved Commercial and non commercial portfolio studies Cancer specialty specific objectives Recruitment overall at 20% cancer incidence Recruitment to interventional studies at 7.5% of cancer incidence Recruitment to rare cancer studies

How important is cancer on our patch? Cancer incidence recruiting studies £2 million (16%) Funding per incident case approx £220 Funding per recruit £800 Exceeded both recruitment targets for last 2 years Largest non commercial portfolio Benefit from continued good national and international links

Recruiting studies Study Acronym/Title Gloucestershire Hospitals NHS Foundation Trust Royal United Hospital Bath NHS Trust Taunton and Somerset NHS Foundation Trust University Hospitals Bristol NHS Foundation Trust Grand Total ART DECO 33 De-ESCALaTE HPV Developing a core information set for consent to oral cancer surgery 98 HeadandNeck5000 – now closed IoN3 710 NIMRAD (NIMorazole/placebo plus RADiotherapy in head and neck cancer) 22 Grand Total

National Portfolio 6 studies in set up. Only 1 open to new sites EORTC 1209EnTF A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.

43 Studies on National Portfolio Only a few open to new sites HOPON - (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomised Controlled Trial of Hyperbaric Oxygen to prevent Osteoradionecrosis of the Irradiated Mandible. Closing 2018, 62% recruited. DAHANCA 21 - Hyperbaric oxygen treatment of mandibular osteoradionecrosis. A randomized clinical study. Closes Dec % recruited so far. Head and Neck Cancer: molecular, cellular and immunological mechanisms - Investigation of the molecular and genetic mechanisms promoting oral cancer development and progression. Closing March 2020, 45% recruited. Head and neck skin malignancy - Investigating molecular and cellular mechanisms of head and neck skin malignancy. Closing April 2019, 12% recruited so far. IoN Is ablative radio-iodine necessary for low risk differentiated thyroid cancer patients. Closing May 2016, 45% recruited. 2 further studies open to new sites but nearing closure date.

Cancer Subspecialty Research Leads Within each network 13 subspecialty research lead roles are identified, mapping onto the national Clinical Studies Groups with the aim of: –Providing link between local network and CSGs –Promoting the research agenda to clinical colleagues across the network –Advising on portfolio planning locally –Attendance at annual meeting to discuss portfolio planning and delivery and horizon scan for new studies –Supporting the research delivery manager for the cancer specialty Role very similar to SSG Research Lead role 17

Imaging Adv. panel Screening, Prevention & Early Diagnosis CTRad (Radiotherapy) Psychosocial & Survivorship Teenage & Young Adult Teenage & Young Adult Palliative & Supportive Care Palliative & Supportive Care Biomarkers Adv. panel Primary Care Primary Care Consumer Liaison Group Breast Cancer CSG Breast Cancer CSG Lung Cancer CSG Lung Cancer CSG Upper GI Cancer CSG Upper GI Cancer CSG Colorectal Cancer CSG Colorectal Cancer CSG Kidney Cancer CSG Kidney Cancer CSG Bladder Cancer CSG Bladder Cancer CSG Testis Cancer CSG Testis Cancer CSG Gynae Cancer CSG Gynae Cancer CSG PPI Brain Tumours CSG Brain Tumours CSG Head & Neck CSG Head & Neck CSG Sarcoma CSG Sarcoma CSG Melanoma CSG Melanoma CSG Lymphoma CSG Lymphoma CSG Haematol. CSG Haematol. CSG Prostate Cancer CSG Prostate Cancer CSG Children’s Cancer & Leukaemia National Clinical Studies Groups

Division 1 Clinical Lead Brain cancer H&N cancer Lung cancer Breast cancer Sarcoma Skin Cancer Children/young people Upper GI cancer Colorectal cancer Urological cancer Gynae cancer Haem/lymphoma Pall/Supportive & Psychosocial 13 LCRN Subspecialty Leads: LCRN (x15) Clinical Director CRN WE Exec Board COO Division 1 RDM Research Delivery Teams Partnership Group Clin. Advisory Group [ +/- other clinical roles]

Call for H&N sub-specialty lead in CRN - West of England Each SSG already has a research lead We are looking for a research lead in each tumour site to represent the network locally and nationally in terms of developing and supporting the portfolio and providing clinical specialty support to the Research Delivery Manager and Principal Investigators across the network Expenses to attend national meetings will be met by the network Discussion: –Your current research lead continuing and taking on the network representation and/or –The nomination of a West of England research lead who will take on network representation 20

Contact & reference details academics/nihrcrn-portfolio/ academics/nihrcrn-portfolio/ 21