"Please join us for this online workshop aiming to stimulate clinical trial research in ME/CFS. The speakers and discussions will look at clinical trial design in people with ME/CFS – how to optimise it, and lessons from other disease areas. This is the first in a series of online workshops on clinical research in ME/CFS. The workshops are connected with the Research Working Group set up by the UK Clinical Research Collaboration. The workshops aim to raise the profile of ME/CFS clinical research, increase collaboration, attract new researchers and formulate research priorities in this area of huge unmet need." More details at https://www.eventbrite.com/e/clinical-trial-design-in-people-with-mecfs-tickets-874512268737
I guess a lot depends on the number and quality of speakers, but this series of workshop seems like a big step forward and well thought through. Thanks to everyone if you help bring these about. Sounds like the department of health and social care played a leading role?
Looks interesting. Pleased to see Caroline Kingdon involved as she’s great. And involvement from a teaching hospital/medical school near me. Is there any more info about these workshops or how they came about anywhere?
They are part of the government research working party initiative. Monica Bolton has been organising these - she is interested in naltrexone.
The real problem is that nobody has any clear idea what drugs to test, except naltrexone. Applications for funding for naltrexone trials have been turned down. I am a bit sceptical about broad brush overviews of 'core outcome measures' when each type of trial needs outcome measures tailored to the expected benefit and the study design.
I doubt it's a realistic process. Even diseases with such a clearly known pathological mechanism that they can benefit from massively parallel automated testing are barely seeing any results yet, there are too many possible combinations to try and the process of human trials is the slowest possible way of doing this, billions of times too slow to work out. Not a typo, billions of times too slow, hell possibly trillions. Someone would have better chances at striking a massive source of gold by randomly digging around with a trowel once every week.
"Chair - Professor Harm van Marwijk, Professor in General Practice at Brighton and Sussex Medical School Speakers Sarah Gorst – COMET Initiative Project Co-ordinator (Core Outcome Measures in Effectiveness Trials). A Core Outcome Set was identified as a research priority in the 2021 NICE guideline for ME/CFS, and COMET were recently involved in the development of a Core Outcome Set for long COVID. Sarah Tyson – Honorary Professor of Rehabilitation at University of Manchester, who is currently developing a clinical assessment tool kit for use in ME/CFS clinics. Caroline Kingdon – Research Fellow at London School of Hygiene and Tropical Medicine, CureME and ME Biobank co-ordinator, who has wide experience of the needs of people with ME/CFS in clinical research. Anna Williams – Professor of Regenerative Neurology at Edinburgh University, who chairs the Treatment Selection Committee of the OCTOPUS platform study in multiple sclerosis – a multi-arm multi-stage treatment trial. Jessica Eccles – Reader in Brain-Body Medicine at Brighton and Sussex Medical School, who recently held a Public Engagement Event at Brighton and Sussex Medical School on the next steps for ME/CFS drug repurposing research with feedback from attendees on what adaptations people with ME/CFS needed in clinical studies." Caroline Kingdon might be involved, but so are Tyson and Eccles, both of whom have proved to be problematic.
It's a mixed bag. Caroline is very good at what she does but I am not sure that she has any particular experience with trials. The COMET initiative is a Delphi approach, which tends to be the worst way to do things. Eminence based medicine. The MS study would be relevant if we had six drugs to test and something to see on MRI, but we don't at the moment. Outcome measures are going to depend on what the drug is supposed to help with in symptomatic terms, and that is far from clear, even for naltrexone. The only corroborative objective measures we really have are altimetry and employment status.
I would certainly agree that it is important to be able to measure how high you are after taking any drugs.
From: Helen Baxter Further to the information below, people can send in questions whether or not they are attending, and the organisers will try to get the speakers to address any questions sent in. It is hoped that the workshops will be recorded. If so, the recordings will be made available online. Kind regards Helen Baxter 25% ME Group
