Ambulance studies are on the rise. Globally, cardiologists, funders and CRO's are coming together to perform pre-hospital phase trials with one main goal: to advance the commencement of treatment, before patients reach the hospital. Because those early minutes are crucial.
We’re talking to Prof. Arnoud van ‘t Hof, M.D., Ph.D., FESC, Head of the Department of Interventional Cardiology in the MUMC, Maastricht and the Zuyderland MC in Heerlen, The Netherlands. He’s been playing a key role in Diagram’s ambulance studies and is the Principal Investigator of the current CELEBRATE trial.
As of 1st November, the VGO became mandatory for drug trials, replacing the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands.
Dr. J. Thannhauser has defended his PhD thesis titled Technical Innovations in Out-of-Hospital Cardiac Arrest: On the Road to a Smart Defibrillator on 30th September 2021 at the Radboud university medical center, Nijmegen, The Netherlands.
To mark this monumental occasion, we briefly caught up with Jos about his research.
UPDATE ON PREVIOUS ANNOUNCEMENT REGARDING THE NEW SITE SUITABILITY DECLARATION/VGO
As of 1st November, the VGO becomes mandatory for drug trials, replacing the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands.
Are you passionate about clinical scientific research? Do you love to work together with cardiologists and patients to setup and run successful trials? Then we’re looking for you to join our R&D team as research nurse specialist.
The COMBINE trial, published in the European Heart Journal and recently presented as a Late Breaking Trial during TCT Connect 2020, shows that patients with a OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia.
The Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) is a declaration of feasibility of a clinical study in a (research) centre in the Netherlands. It’s a new document that replaces the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands. It is part of the new procedure Local Feasibility.
On 26th May 2021, Europe implemented stricter rules for medical devices (MDR) aiming to give patients more clarity and enabling them to make a better and well-informed choice. The new directives have consequences for manufacturers, importers, distributors and care providers.