I’ve been neglecting my blogging duties, but I have an excuse, which is that I had the team and myself on ‘slogging’ duties to get ChariotMS underway:-)
ChariotMS is an ‘investigator-led’ trial, and that really means doing all related jobs yourself, from protocol writing to participant-information & consent sheets, case report forms, database, statistics, randomisation system, in short: everything. I say everything, but there are some significant exceptions such as randomisation, part of the lab tests, and – of course – the drug we’re going to test, which is made & shipped by Merck (and hopefully not held up at the new Brexit barrier…).
Anyway, a few weeks ago we had our meeting with the Westminster Research Ethics Committee, and bar a few minor issues, they were happy with our submission, as was the MHRA, so we’re on track to recruit our first participant on 4th of Jan 2021 !
A huge credit to the team, particularly our (relative) newbie and principal trial manager, Harpreet Mangat, digital editor and PPI member Christine Chapman, who is responsible (for example) for this, and David Lieberman, who not only helped writing the protocol and many of the ancillary documents, but with the myriad of discussions & meetings that go into such a project. The list of people having carried ChariotMS to this is stage is long; I will introduce them in due course so they all get the credit they truly deserve.
Whilst we will update here on the blog, and soon activate a dedicated ChariotMS website, the MS Society has kindly taken the lead on PR for now, closely watched by all who contributed no small amounts of cash and other support, including the MRC/NIHR-EME, the National US MS Society, Barts Charity and Merck KGaA (Thank you all!).
The MS Society will produce some flurry of activity about ChariotMS across platforms later this week, in the context of their STOP MS campaign and Christmas appeal (I trust you’ve also read yesterday’s post by MD explaining the lenghts & depths the MSS has gone to select the most promising add-on candidates for progressive MS; who knows ChariotMS might lead to a platform on which future add-ons could be layered) – please support them if you can, and remember ChariotMS currently includes only 2 years follow-up, so we need additional funding for an extension study to make it 4 years in total, and the initiative to gather momentum for this starts now. It be unforgivable if we wouldn’t follow-up the 200 pwMS enrolled in ChariotMS beyond 2 years. Though we are hopeful to detect the effect of treatment after 2 years, it might take a little longer than that to reach statistical significance; I’ll get back on this!