Diagnostic Evidence Co-operative Newcastle

Overview of services and capabilities The NIHR Diagnostic Evidence Co-operatives are established to support industry with the generation of high quality evidence on commercially available in vitro diagnostic test.

Introduction The National Institute for Health Research (NIHR) funds four Diagnostic Evidence Co-operatives (DECs) to help generate information on the clinical utility, cost-effectiveness, and care pathway benefits of in vitro diagnostics (IVDs). The DECs work collaboratively with experts from across the NHS, academia, and industry. This collaborative approach has the potential to lead to improvements in healthcare services and the quality of life of NHS patients, by helping patients access the most appropriate diagnostic technologies more quickly and help the NHS make the best use of its resources. The other DECs are based at Leeds, Oxford, and London (Imperial).

Clinical themes

Collaboration

The NIHR DEC Newcastle focuses its activity on the strengths of the clinical research activity based in Newcastle. We are able to cover a broad range of clinical themes, including, but not limited to: • Infectious disease • Molecular genetics • Liver • Stroke and cardiovascular • Respiratory • Musculoskeletal • Cancer

The NIHR DEC Newcastle collaborates closely with a number of organisations during the delivery of its research, these include: • Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) • Newcastle University - Institute of Health and Society, School of Mathematics and Statistics, and School of Biology • Clinical Measurement and Engineering Unit of Northern Medical Physics and Clinical Engineering (NuTH), including links with the Newcastle and York NICE External Assessment Centre • Newcastle Molecular Pathology Node • Newcastle Biomedical Biobank • VOICENorth Research Support Group

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University

Creating an evidence development strategy

Working with you to run a successful study

We believe that working with you to produce an Evidence Development Strategy is one of the most important steps to help you generate the evaluation evidence required to expedite the adoption of your diagnostic test by the NHS and wider market.

Once it has been decided which studies to undertake, and funding has been secured, the NIHR DEC Newcastle will work with you to help design, deliver and manage the studies, and ensure they are delivered to time and budget.

The NIHR DEC Newcastle will help you to identify where your device is currently placed on the evidence development pathway. We will work with you to understand the evidence you already have, and to help identify the gaps in evidence. We can then develop a plan of potential studies to generate the required evidence to demonstrate the benefit of your test to patients and the NHS.

Methodology development In order to deliver studies in the most cost efficient and timely manner the NIHR DEC Newcastle will seek to utilise the most up-to-date and novel approaches to IVD evaluation, both in clinical trial design and in health economics studies. The four NIHR DECs are also working collaboratively, via the DEC Methodology Group, on researching and developing new methodologic approaches for IVD evaluation. The group includes representation from the National Institute for Health and Care Excellence (NICE) to help ensure that evidence generate is relevant to the NICE Diagnostic Assessment Programme (DAP).

The DEC will work with you to identify the most suitable source of funding for your study. We will also develop the most appropriate contractual arrangement with you, whether this is a collaborative arrangement, or a fee for contract services.

Services available from the NIHR DEC Newcastle: • End-to-end study development and management • Development of the study protocol and statistical analysis plan • Patient and public involvement in the study design • Applying for Research Ethics approval and NHS Permission (R&D Approval) • Development and generation of patient information sheets, consent forms and test request forms via our ‘Work Packet System’ • Data capture and secure storage via the ‘Work Packet System’ • Liaison between trial sites • Ensuring study staff are trained in the study protocol and test procedures • Study progress monitoring • Assistance with preparation of interim progress reports to funders, sponsors and regulatory bodies • Data collation, cleansing, and analysis • Study report preparation • Preparation of papers for submission to journals

www.newcastle.dec.nihr.ac.uk | [email protected] |

@NIHR_DEC_Ncl

The NIHR Diagnostic Evidence Co-operative Newcastle is delivered in partnership between Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University