Research

We are currently involved in over 100 clinical trials and other studies ranging from testing new surgical devices to trialling new drugs.

However, research projects cannot get started without the participation of our patients. We rely heavily on the thousands of patients we treat every year to volunteer and take part in research projects.

This arrangement is mutually beneficial because we get to see how new treatments work in practice and our patients benefit from ground-breaking treatments earlier than they would otherwise.

The Research Office is heavily involved in Clinical Research and actively involved with listed National Institute for Health and Research’s (NIHR) portfolio, a national information point of studies being run across the UK.

Time and target outcome

Performance in Initiating and Delivering Clinical Research

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research. The aim is to increase the number of patients who have the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research.

Since July 2013, Clinical Trial providers holding NIHR contracts are required to publish outcomes against the 40 day and 30 day benchmark and delivery to time and target metrics.

These tables are an accurate representation of trial status at the point of reporting and are updated on a quarterly basis.

The quarterly performance is now on the NIHR platform

2022-2023

Q1: 2022/23 Performance in initiating

Q1: 2022/23 Performance in delivering

2021-2022

Q1: 2021/22 Performance in initiating

Q1: 2021/22 Performance in delivering

Q2: 2021/22 Performance in initiating

Q2: 2021/22 Performance in delivering

Q3: 2021/22 Performance in initiating

Q3: 2021/22 Performance in delivering

Q4: 2021/22 Performance in initiating

Q4:: 2021/22 Performance in delivering

2019-2020

Q4: 2019/20 Performance in initiating

Q4: 2019/20 Performance in delivery no commercial trials closed to recruitment in this quarter

Q1: 2020/21 Performance in initiating

Q1: 2020/21 Performance in delivery no commercial trials closed to recruitment in this quarter

Q2: 2020/21 Performance in initiating

Q2: 2020/21 Performance in delivery no commercial trials closed to recruitment in this quarter

These reports are updated on a quarterly basis.

If there are any questions about these reports or the benchmarks themselves, please contact: Janet Forkes, Senior Research Manager

Research trials

At the heart of the Clinical Research Network’s activities is the NIHR Clinical Research Network (NIHR CRN) Portfolio of studies. This consists of high-quality clinical research studies that are eligible for consideration for support from the Clinical Research Network in England.

Research activity (recruitment) data from the NIHR CRN Portfolio is used to inform the allocation of NHS infrastructure for research (including NHS Service Support Costs) and supports the performance management of the Clinical Research Network.

UK Clinical Research Network Portfolio of Studies

The NIHR Clinical Research Network Portfolio is part of the UK Clinical Research Network Portfolio of studies, which comprises the network Portfolios for England, Northern Ireland, Scotland and Wales. These four Portfolios are held on a single information system: the Central Portfolio Management System (CPMS).

For information on available trials visit UK Clinical Trials Gateway.

Taking part

If you are treated at one of our hospitals, you may be invited to take part in clinical research. It is entirely up to you whether or not you wish to be involved. If you decide not to participate, you will still be treated with the best care currently available.

The length of time each study takes and what you’ll need to do varies depending on what is being investigated and on the specific tests and measurements that are needed. Some trials may involve overnight stays, or making additional visits to hospital. The research staff will also explain this to you along with the eligibility and screening. Patients from hospitals outside our Trust can take part in our trials dependent on eligibility criteria but would need referral to a specialist team at our hospitals.

Standard Operating Procedures (SOPs)

Chief and Principal Investigators, all other research personnel who have been delegated roles and responsibilities and the staff of the R&D Department who have the function of research governance for our hospitals must adhere to this set of procedures when undertaking research:.

• SOP 03 Training (Trial Delivery 02)
• SOP 04 Informed Consent in Research (Trial Delivery 03)
• SOP 05 End of Trial Procedures (Trial Delivery 04)
• SOP 06 Trial Archiving (Trial Delivery 05)
• SOP 07 Managing Participant Expenses (Trial Delivery 06)
• SOP 09 Medicines Management (Trial delivery 08)
• SOP 10 Hosting CTIMPs and other Clinical Studies (Managing Research 01)
• SOP 11 Confirmation of Capacity and Capability (Managing Research 02)
• SOP 16 Managing MHHRA Inspection (Managing Research 07)
• SOP 17 Radiotherapy trial management at satellite sites (Managing Research 08)
• SOP 18 Application Process for an Honorary Contract, Letter of Access or Research Passport (Managing Research 09)

Researcher’s initial engagement in research with the Trust

• Initiating Research 01 - Sponsorship
• Initiating Research 02 - Honorary Contract
• Initiating Research 03 - Writing a Protocol

R&D management of research

• Managing Research 03 - EDGE
• Managing Research 04 - Monitoring
• Managing Research 05 - Commercial Income
• Managing Research 06 - Sue Ryder

Reporting requirements - Pharmacovigilance

• Pharmacovigilance 01 - Periodic Reporting
• Pharmacovigilance 02 - Adverse Events
• Pharmacovigilance 03 - Misconduct
• Pharmacovigilance 04 - Serious Breaches

Research Development

• Research Development 01 - Scientific Review
• Research Development 02 - Sponsorship
• Research Development 03 - Staff Survey

Trial Delivery

• Trial Delivery 01 - File Management

Managing SOPs

• Managing 01 – Preparation, Review and Approval of Standard Operating Procedures for Research

Frequently Asked Questions (FAQs)

More information on research at our hospitals is available here

Working in partnership

National Institute for Health Research

They are funded by the Department of Health to improve the health and wealth of the nation through research.

Read more about the National Institute for Health Research

University of Gloucestershire

Each of the eight academic schools contribute to their learning-led, research-informed environment. They embed research in all activities, ensuring students and staff benefit from and contribute to vibrant subject communities, engaged in fundamental and applied research.

Their research priority areas build on strengths and recognise the opportunities to contribute to contemporary challenges which include:

• Sport, exercise, health and well-being
• Environmental dynamics and governance
• Being Human: past, present and future
• Innovation, design and technology
• Applied business research
• Learning from professional contexts

Read more about the University of Gloucesteshire

West of England Clinical Research Network

As the NIHR Clinical Research Network, West of England, they help to increase the opportunities for patients to take part in clinical research, ensure that studies are carried out efficiently and support the Government’s Strategy for UK Life Sciences by improving the environment for commercial contract clinical research.

Read more about the West of England Clinical Research Network

Research Design Service (RDS)

Each RDS office is run by an experienced researcher, well-equipped to provide practical and user-friendly advice on the research process and on applying for funding.

For further information on who they are and how they can help, visit: www.rds-sw.nihr.ac.uk

Good Clinical Practice (GCP)

Everyone involved in the conduct of clinical research must have training in Good Clinical Practice to ensure they are best prepared to carry out their duties. This is laid down in the Research Governance Framework for Health and Social Care 2005, covering all research in the NHS in England, and in law for those people working on clinical trials.

The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s), 2.8, E6 Guideline for Good Clinical Practice.

To download a copy of the NIHR Training Programme for GCP visit NIHR CRN Training Programme.

The team