Sponsorship

We can take the sponsorship role but have flexibility.

Particular areas of interest or experience in cardiovascular trial design and delivery

Collaboration is central to the Unit’s approach, bringing together multidisciplinary expertise via formal collaboration with both the MRC Biostatistics Unit (Cambridge) and Kings College Health Economics teams (London). PTUC is situated within The Victor Phillip Dahdaleh Heart and Lung Research Institute (VPD-HLRI), a joint venture between Royal Papworth Hospital and the University of Cambridge, a venture that combines world-leading life science, translational research and clinical excellence, with access to the HLRI Clinical Research Facility: https://royalpapworth.nhs.uk/research-and-development/hlri/clinical-research-facility.

The Trials Unit has extensive experience in the design, set-up and delivery of cardiovascular clinical research across the full study lifecycle, supporting both investigator-led and commercially sponsored studies. Its expertise encompasses complex interventional and observational studies, including Clinical Trials of Investigational Medicinal Products (CTIMPs), medical device investigations and studies involving advanced cardiovascular interventions.

The Unit provides comprehensive trial management, regulatory, governance and operational support, working collaboratively with investigators, statisticians, methodologists, clinicians and NHS organisations to develop scientifically robust and operationally feasible study designs. Particular strengths include regulatory strategy and approvals, study governance, risk-based trial management, safety oversight, multicentre study delivery, data quality assurance and compliance with UK and international regulatory requirements.

The Unit has a strong interest in supporting innovative cardiovascular research, including studies evaluating novel therapeutics, medical technologies and transplantation. It has experience navigating the complex regulatory and operational challenges associated with these studies while ensuring participant safety, data integrity and efficient trial delivery.

QUACS: Quality of life After Cardiac Surgery: a national multicentre observational study.

CI: Mr S. Nashef.

Sponsor: Royal Papworth Hospital NHS Foundation Trust.

Click here to read the protocol: https://royalpapworth.nhs.uk/application/files/7715/7891/3621/QUACS_Protocol_V3_090919_Clean.pdf

View the QUACS lay summary: https://royalpapworth.nhs.uk/research-and-development/patients-and-public/research-project-summaries

NOTACS: Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a multicentre randomised controlled trial with participating sites in the UK, Australia and New Zealand.

CI: Dr A Klein.

Sponsor: Royal Papworth Hospital NHS Foundation Trust.

NOTACS is registered on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05308719

The NOTACS protocol: https://link.springer.com/article/10.1186/s13063-022-06180-5

View the NOTACS lay summary: https://royalpapworth.nhs.uk/research-and-development/patients-and-public/research-project-summaries

BIOPATTERN: Site of disease BIOmolecule capture and analysis in PATienTs with established coronary disease undERgoing iNtracoronary assessment.

CI: Dr Stephen Hoole.

Sponsor: PlaqueTec.

Click here for an article about the study: https://royalpapworth.nhs.uk/our-hospital/latest-news/new-uk-trial-atherosclerotic-cardiovascular-diseases 

View the BIOPATTERN lay summary: https://royalpapworth.nhs.uk/research-and-development/patients-and-public/research-project-summaries

SPORT: Second Primary lung cancer cohORT study.

CI: Dr R. Rintoul.

Sponsor: Royal Papworth Hospital NHS Foundation Trust.

Click here for further information: https://clinicaltrials.gov/study/NCT04178889

View the SPORT lay summary: https://royalpapworth.nhs.uk/research-and-development/patients-and-public/research-project-summaries/sport-study

StratosPHere: Optimal biomarkers to ascertain target engagement in therapies targeting the BMPR2 pathway in Pulmonary Arterial Hypertension (PAH).

CI: Dr Mark Toshner.

Sponsor: University of Cambridge & Royal Papworth Hospital Foundation Trust.

StratosPHere is registered on ISRCTN: https://www.isrctn.com/ISRCTN10304915?q=STRATOSPHERE&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10

Address: Royal Papworth Hospital NHS Foundation Trust. Papworth Road, Cambridge Biomedical Campus, Cambridge, CB2 0AY

Telephone number: 01223 638 000

Email address: sarah.fielding2@nhs.net

Website: https://royalpapworth.nhs.uk/research-and-development/papworth-trials-unit-collaboration