Just a mini-post to mark a mini-milestone: today Santé-AF went to its sponsor for sign-off. This means the trial design stage is finished and the trial protocol, now at version 0.9, can be regarded as definitive (other than any changes required by the sponsor or by Ethics). That was a small sentence to write, but it represents months of hard work, thinking, reading and discussion! Once sign-off has been received, we can submit the trial for ethical approval via the Health Research Authority’s Integrated Research Application System (IRAS).
The study’s sponsor is the University of York’s Contracts & Sponsorship department, which handles all the study sponsorship for the whole of the University including its world-leading clinical trials unit, the York Trials Unit. Santé-AF, being a PhD study, is very small fry compared with some of the trials that YTU is currently handling, but it will take its place in the queue along with everything else. Ethically speaking, a trial for 30 participants is no less work than a trial for 300 participants – so the Contracts & Sponsorship’s due diligence will be of the same order and timescale as for bigger trials.
The process of sponsor sign-off is all handled via the IRAS system, which has been educational in its own right. IRAS isn’t the easiest web-based application to use, but it’s been a helpful process to think about and rewrite descriptions of key aspects of the trial (as IRAS explicitly forbids the simple cut-and-paste of portions of the trial protocol). In the process, this has helped to strengthen the rationale for making certain design decisions, such as the choice of a pragmatic, open trial; the allocation ratio; the sample size; the choice of the therapies under investigation. All in all, it’s made for a deeper and more reasoned design, which will be very helpful for me personally when it comes to PhD viva time!