Preoperative Volume Replacement vs. usual care in Diabetic patients having CABG surgery: a randomised controlled Trial
A CTIMP RCT that was running as a single centre in the UK, and due to logistical reasons was not recruiting to time and target. The CI asked a colleague in India to run a parallel study so that the overall target samples size could be reached in a timelier manner, and the results of the studies were combined in an IMPD metanalysis. The trials were completely independent and had separate governance and approvals. Data was collated and analysed by the staff from the UK trial. The UK team allowed their study documents to be used for the India trial.
Countries: UK and India
The studies had separate Sponsors (in the UK it was the site’s local NHS Trust).
The studies had separate finances.
NA
The studies had their own insurance and indemnity arrangements.
The UK and overseas sites followed their own research governance procedures. The UK site asked that the overseas sites gave confirmation that the correct approvals were in place.
The overseas suites adopted the UK protocol. Unblinded trial design, operative specifics and operative decision making are at the discretion of the operating surgeon.
UK site was monitored by the Sponsor.
NA
The UK site used a purpose-built NHS hosted database; the overseas site sent scanned completed paper CRFs to the UK site for data entry on to their database.
No samples were collected for the overseas sites; any blood tests were performed locally, and results submitted on the CRFs.
Local sites collected resource use data; the overseas centre did not use the quality of life questionnaires.
Each site retained the rights to their data. The site PIs were named as authors on the results publication.
Obstacles encountered
The UK team were less able to oversee data quality than they usually have with a multicentre trial and had to accept that data that they received with very little opportunity for querying any inconsistent or missing data. The healthcare systems are very different, which led to differences in the way participants were managed. There were differences in the SAE reporting processes that led to hugely different SAE rates between the two trials.