Delivering clinical research to make patients, and the NHS, better Lung Cancer Research Report Site Specific Group Meeting Tuesday 11 th November 2014.

Delivering clinical research to make patients, and the NHS, better

Lung Cancer Research Report

Site Specific Group MeetingTuesday 11th November 2014

Maxine TaylorSenior 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 1st 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 August 1st• - 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

• Divisions 2 & 6

• Divisions 3 & 4

• Division 5

• Division 1

Maxine TaylorSenior RDM Workforce

Development

Martine CrossSenior RDM RM&G and

Industry Lead

Ruth AllenRDM

Business Intelligence lead

Chantal SunterRDM

PCPIE and Comms Lead

Mary PerkinsChief Operating Officer

Network Clinical Divisions• CancerDivision 1

• Diabetes Renal• Stroke Metabolic & endocrine• CardiovascularDivision 2• Children Reproductive health & childbirth• Genetics HaematologyDivision 3• Mental Health• Dementias & neurodegenerative diseases• NeurologyDivision 4• Primary care Ageing

Health services research• Oral & dental Dermatology• Musculoskeletal Public Health

Division 5• ENT Anaesthesia &

pain management• Surgery Critical care• Respiratory Opthalmology

• Critical care Infectious diseases

• Hepatology Gastroenterology

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

How important is cancer on our patch?

58

23

172120

34

67

Research staff WTE per division

Div 1Div 2Div 3Div 4Div 5 Div 6Generic

• Cancer incidence 9544• 242 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

West of England specialty portfolio compared to national

AgeingAnaesthesia, perioperative medicine and pain

CancerCardiovascular disease

ChildrenCritical care

Dementias and neurodegenerationDermatology

DiabetesEar, nose and throat

GastroenterologyGenetics

HaematologyHealth services and delivery research

HepatologyInfectious diseases and microbiology

Injuries and emergenciesMental Health

Metabolic and endocrine disordersMusculoskeletal disorders

Neurological disordersOphthalmology

Oral and dental healthPrimary CarePublic health

Renal disordersReproductive health and childbirth

Respiratory disordersStroke

Surgery

0 100 200 300 400 500 600 700 800

WE portfolio

National portfolio

Total studies 3827WE total 546=14%

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

CRN: West of England Performance against goals 14/15 (Apr 2014 - Sep 2014)

Recruitment (Apr 2014 - Sep 2014) Recruitment goal (Apr 2014 - Sep 2014) Recruitment goal 2014/15Data extracted: 27 Oct 14 Primary Care goal 14/15: 9224

Recruitment by Trust and study designApril – Oct 2014

Glos Swindon NBT Bath UHB Weston0

5

10

15

20

25

30

35

40

45

ObservationalInterventional

13

Recruitment by Trust and studyApril – Oct 2014

14

0

5

10

15

20

25

30

35

40

45

DIAPHRAGM

Investigation of pleural disease: improving the patient pathway 1

Lung ART

LungCAST

MEDLUNG

NCRN - 2974 VESTA: Veliparib, car-boplatin & paclitaxel in NSCLC

NCRN533 - Met inhibitor+/- Erlotinib in Met+ Eroltinib resistant NSCLC

NCRN552- ASCEND V

QUARTZ

STOMP

TIMELY

WE Lung portfolio

15

Gloucestershire Hospitals NHS Foundation Trust 14LungCAST 10NCRN - 2974 VESTA: Veliparib, carboplatin & paclitaxel in NSCLC 2NCRN552- ASCEND V 2

Great Western Hospital 11MEDLUNG 11

North Bristol NHS Trust 42DIAPHRAGM 0Investigation of pleural disease: improving the patient pathway 1 41NCRN533 - Met inhibitor+/- Erlotinib in Met+ Eroltinib resistant NSCLC 1

University Hospitals Bristol NHS Foundation Trust 1Lung ART 0QUARTZ 0STOMP 1

Weston Area Health NHS Trust 3QUARTZ 3TIMELY 0

Grand Total 71

New studies to discuss:

Portfolio search criteria – open to new sites with >12 months to run

16

SPUtNIk - Accuracy and cost-effectiveness of dynamic contrast enhanced computed tomography in the characterisation of solitary pulmonary noduleClosure date – March 2017CI Dr Steve George, Southampton

TAPPS - Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry: a randomised trial to determine the most effective method for the management of malignant pleural effusions in patients with a good performance statusClosure date – Jan 2017CI Dr Nick Maskell, NBT, Bristol

MARS2

A study to determine if it is feasible to recruit into a randomised trial comparing (extended) pleurectomy decortication versus no pleurectomy decortication in the multimodality management of patients with malignant pleural mesotheliomaIN SET UP. CI – Dr Eric Lim, Royal Brompton, London

New studies continued

CEDAR - A Phase II, randomised, open-label study of Gemcitabine/Carboplatin first-line chemotherapy in combination with or without the antisense oligonucleotide Apatorsen (OGX427) in advanced squamous cell lung cancersClosure date – Dec 2016CI – Prof Peter Schmid, Queen Mary’s, London

17

Commercial studies

• NCRN569- LDK378 in ALK+ advanced NSCLC - ASCEND IV - A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), locally advanced or metastatic, non-squamous non-small cell lung cancer

• NCRN552- ASCEND V - A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

• NCRN - 2974 VESTA: Veliparib, carboplatin & paclitaxel in NSCLC - A Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib PlusCarboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously UntreatedAdvanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

18

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

19

Imaging Adv. panel

Screening, Prevention &

Early Diagnosis

CTRad (Radiotherapy)

Psychosocial & Survivorship

Teenage &Young Adult

Palliative & Supportive Care

Biomarkers Adv. panel

Primary Care

Consumer Liaison Group

Breast CancerCSG

Lung CancerCSG Upper GI

CancerCSG

Colorectal CancerCSG

Kidney CancerCSG

Bladder CancerCSGTestis

CancerCSG

Gynae CancerCSG

PPI

Brain Tumours

CSGHead & Neck CSG

SarcomaCSG

MelanomaCSG

LymphomaCSG

Haematol.CSG Prostate

CancerCSG

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 Lung sub-specialty leadin 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

• Please discuss:– Your current research lead continuing and taking on

the network representation– The nomination of a new research lead who will take

on network representation 22

Contact & reference details

• [email protected]

• [email protected]

• http://csg.ncri.org.uk/portfolio-maps/

• https://www.edge.nhs.uk/Account/Index?ReturnUrl=%2f

• http://www.crn.nihr.ac.uk/can-help/funders-academics/nihrcrn-portfolio/

23