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The William Harvey Research Institute - Barts and The London

For Researchers

The CVCTU is currently leading on a wide range of trials with the cardiovascular speciality with local Investigators at Barts Health NHS Trust and Queen Mary University of London, and also external companies. Our aim is to support and oversee the trials to ensure high-quality research and results are generated, and to assist with informing and changing modern clinical and health care practice.

Information about the trials that the CVCTU have in set-up and actively recruiting are detailed in the section below.

What type of studies do we support?

The CVCTU supports Clinical Trials of Investigational Medicinal Products (CTIMPs), non-CTIMPs (which include trials of complex interventions) and device studies, whether these are single-centre, multi-centre, national or international studies. The aim is to support local investigators to deliver high-quality trials by providing oversight of the main trial activities. The CVCTU is a core resource providing infrastructure support for clinical cardiovascular research.

What services will the Barts CTU provide?

If you wish to have the Barts CVCTU as your official trials unit for a study, it will provide oversight of the main trial activities, and also provide specific resource services as requested, which may include:

Trial design, risk assessment, costings, protocol development, obtaining approvals (MHRA, NRES, NHS), regulatory and ethics submissions, statistical design and analysis, study oversight, data management, database development and CRF design, randomisation and unblinding, patient and public involvement, IMP management, and recruitment of study staff. 

What is the process for Barts CVCTU portfolio adoption?

If you are interested in seeking our advice or collaborating with us on a study, please contact us by phone or email. We recommend making contact at an early stage and preferably at the point of grant application development. By contacting us early this will enable you to take full advantage of our wealth of experience and expertise, and increases the likelihood of a successful application.

Our CVCTU Flowchart [PDF 41KB] explains the current procedure if you would like our clinical Trials Unit support for your study.

What should I do if I would like support from the Barts CVCTU?

To gain adoption onto the CVCTU portfolio, you need to submit the CVCTU Enquiry form [DOC 268KB] confirming full or outline submission to the CVCTU team - Email: CVCTU@qmul.ac.uk

This will then be reviewed by the CVCTU Scientific & Resource Committees.

Please aim to submit your enquiry form to us 8 weeks prior to the funding deadline for a full submission, and at least 4 weeks prior for an outline funding submission, otherwise we cannot guarantee to provide a complete review and response by your application deadline.

The Barts Cardiovascular Clinical Trials Unit (CVCTU) is overseen and directed by a Steering Committee, and adoption of trials onto the CVCTU portfolio is managed by Scientific and Resource Committees. 

Steering Committee

The CVCTU Steering Committee oversees the strategic development, vision and work of the CVCTU, including:

  • Delivery of clinical trials within the cardiovascular field with existing teams at the Barts Heart Centre
  • Promotion of the CVCTU to Investigators within Barts Health NHS Trust and Queen Mary University of London, and wider clinical networks as the CVCTU develops
  • Generation of external grant income to support the CVCTU core team
  • Review of resources and recruitment of staff
  • Oversight of the CVCTU trial portfolio and research management.

Members

Chair  - Professor Amrita Ahluwalia – CVCTU Director
Dr. Sam Mohiddin – Barts NHS Trust clinical expert
Dr Steffen Peterson - BHC Research Director
Dr Dan Jones – CVCTU Clinical Senior Lecturer
Dr Ajay Gupta – CVCTU Clinical Senior Lecturer
Dr Vivienne Monk  - CVCTU Manager
Jane Field – CVCTU Clinical Trials Manager
Jackie Cooper – CVCTU Senior Statistician
John Whiteley – Director Strategic Development Delivery, WHRI
Dr David Collier – Director of Barts CTU
Benoit Aigret – Head of Barts CTU
Cheuk Wong – Barts CTU QA Lead

Scientific Committee

The Scientific Committee will review clinical trials submitted for CVCTU portfolio adoption on scientific excellence, appropriateness of study, capacity and capability. 

Meetings are held bi-monthly, and decision for adoption and CVCTU support of the study (unconditional or conditional) will be made and communicated to the Lead Investigator.

Studies may require further review by the committee if the original submission was an outline funding submission, prior to full funding application.

Members

Chair  - Professor Amrita Ahluwalia – CVCTU Director
Dr David Collier – Director of Barts CTU
Dr Sam Mohiddin – Barts NHS Trust Clinical Expert
Professor Steffen Peterson - BHC Research Director
Dr Dan Jones – CVCTU Clinical Senior Lecturer
Dr Ajay Gupta – CVCTU Clinical Senior Lecturer
Jackie Cooper – CVCTU Senior Statistician
Dr Vivienne Monk  - CVCTU Manager

Resource Committee 

The Resource Committee will review studies submitted to the portfolio in terms of resources needed to run and support the study, Risk Assessment, recruitment strategies, study costings, and project accruals. The Resource Committee will assess the study following approval for adoption (as given by the Scientific Committee). The review may be performed remotely via email.

Members

Chair – Dr Vivienne Monk – CVCTU Manager
Jane Field – CVCTU Clinical Trials Manager
Charlotte Saxby - CVCTU Quality Assurance Officer
Natasha Aslam -  CVCTU Trials Coordinator
Jonathan Owens -  CVCTU Database Development Coordinator
Anne Zak – WHRI Heart Centre Nurse Manager

Depending on the trial speciality, a member of the Barts Health NHS Trust Trials team for either Intervention or Electrophysiology will attend this meeting.

If you are interested in seeking our advice or collaborating with us on a study, please do not hesitate to get in touch by phone or email. You can find more details on the ‘Collaborate with CVCTU’ tab.