Trusted Data Safe Havens for Healthcare
Research type
Research Study
Full title
Trusted Data Safe Havens for Healthcare. Our project seeks to develop a framework (technical integrations, contacts network, workflows) by which multiple institutions can access and share appropriately consented health data across European jurisdictions whilst ensuring accountability, privacy and good governance of regional data safe havens.
IRAS ID
208111
Contact name
Andrew D Morris
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Many research questions and methods require data from more than one country, either because of inadequate sample sizes within single countries or because of the need to compare outcomes under different care environments. This proposal has two central aims to:
a) Develop a potential infrastructure that allows for and supports cross-country research within the EU using Electronic Health Records. This project will develop the processes and protocols required to allow prescribing data to be transformed using knowledge from prior pharmaco-epidemological studies. These protocols will be tested in a study of the safety of new non vitamin K Target Specific Oral Anticoagulants (TSOAC)(Aim b).
b) Investigate the safety of the new TSOACs in people who have had an intracranial haemorrhage (ICH). Several recent randomised controlled trials have provided strong evidence supporting the safety and efficacy of TSOACs compared to the vitamin K antagonist warfarin for patients with atrial fibrillation (AF). TSOACs have a favourable risk–benefit profile, with significant reductions in stroke, ICH, and mortality, and with similar major bleeding as for warfarin, but increased gastrointestinal bleeding (Lancet 2014;383:955-62). However, the cost effectiveness of TSOACs is debated (Value Health 2013;16:498-506), TSOAC antidotes are not yet available, and the safety and efficacy of TSOACs are unclear in patients who were not included in the randomised controlled trials but who clinicians feel may benefit. There is a need for an observational study of outcomes associated with TSOACs in people with AF and a past history of ICH. This safety issue needs to be investigated in more than one country (because of its relative rarity), so we plan to use this as a paradigm for aim (a) above.
The study being conducted independently in Italy is separate and has an identified Chief Investigator and Institution that will be solely responsible for Sponsorships, permissions and consents.
REC name
South East Scotland REC 01
REC reference
16/SS/0132
Date of REC Opinion
25 Jul 2016
REC opinion
Favourable Opinion