Funding confirmed
Eleven months and two rejections. The successful application differed from the second mainly in its health-economics section, which we had originally left to an appendix.
ISRCTN 44120876 · phase III
Nine hundred screened, five hundred and fifty-three randomised, and one amendment that cost four months.
The trial compares two existing drugs at a dose neither manufacturer sells. Nobody stood to make money from the result, which is why it took eleven months to fund and why the protocol is published in full.
First site opens
Leeds randomised the first participant nine days after the green light. The other four sites followed over fourteen weeks, three weeks behind the plan.
Protocol amendment
The independent data monitoring committee asked for an additional ECG at week twelve. Re-approval took four months, during which recruitment continued under the original schedule.
Recruitment closes
553 randomised against a target of 540. Belfast under-recruited by a third and Glasgow made up the difference, which the statistical plan had allowed for.
Database lock
Last participant, last visit in December, then ten weeks of query resolution. The analysis code was registered before the blind was broken and has not been edited since.
Screened and randomised, by site900 screened · 553 randomised
Leeds214 / 131
Cardiff186 / 118
Glasgow240 / 152
Belfast97 / 58
Southampton163 / 94
ScreenedRandomised
The protocol, the statistical analysis plan and the full amendment history were registered before recruitment opened and have not been changed since.