Online workshop: Clinical Trial Design in People with ME/CFS, 4th June 2024

"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.

 

Clearly a 'trip' of the spellchecker.

 

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

 

ME Research UK post on the 4 workshops:
Research Workshops – attendance invitation

https://www.meresearch.org.uk/research-workshops-attendance-invitation

 

Posts moved from
UK:ME Association funds research for a new clinical assessment toolkit in NHS ME/CFS specialist services, 2023

Excerpts from Email re workshop tomorrow:


"Clinical trial design in people with ME/CFS on 4th June 2024, 13:00 to 15:30.

The workshop aims to generate research ideas and find ways forward for ME/CFS clinical research in the UK, particularly around the area of clinical trial design in people with ME/CFS.

We are pleased to announce that Professor Sarah Tyson, Honorary Professor of Rehabilitation at the University of Manchester, has agreed to chair this meeting due to the indisposition of Professor van Marwijk.

The workshop is being recorded and we hope to make it available afterwards as a resource. If you prefer, you can change your zoom name so you remain anonymous.

Please listen and respect all contributors’ opinions.

In rare cases where you disagree, feel free to comment, but please don’t be abusive. Any abusive language will not be tolerated, and anyone persisting after a warning would be removed from the workshop.

We have timed breaks at 2pm and just before 3pm. If you are a person with ME/CFS, it is particularly important you pace yourself through the workshop and take extra breaks if needed. You can dip in and out as you need to, use the agenda to decide what parts you want to join.

With kind regards

Monica Bolton



Agenda for online workshop on Clinical trial design in people with ME/CFS on 4th June 2024, 13:00 to 15:30.


13:00 Chair: Sarah Tyson, Honorary Professor of Rehabilitation at University of Manchester

Short introduction: Monica Bolton – person with ME/CFS

13:10 Sarah Gorst – COMET Initiative Project Co-ordinator (Core Outcome Measures in Effectiveness Trials). Core outcome sets, and the development of a core outcome set for long COVID.

13:30 Sarah Tyson – Honorary Professor of Rehabilitation at University of Manchester, outcome measures in ME/CFS clinical studies

13:45 discussion followed by short break

14:10 Caroline Kingdon – Research Fellow at London School of Hygiene and Tropical Medicine, the CureME and ME biobank experience of ME/CFS clinical studies.

14:25 Anna Williams – Professor of Regenerative Neurology at Edinburgh University, the drug selection process for the Octopus platform study for progressive MS.

14:40 Jessica Eccles – Reader in Brain-Body Medicine at Brighton and Sussex Medical School, feedback from previous PPI events on what people with ME want and need to participate in clinical trials.

14:55 short break followed by discussion on ways forward/next steps

 

"In rare cases where you disagree, feel free to comment, but please don’t be abusive. Any abusive language will not be tolerated, and anyone persisting after a warning would be removed from the workshop."



That's an outrageous statement.

1/ Patients disagreeing with, say, Sarah Tyson's PROMS, was not "rare". The assumption that agreement with the speakers would be near universal is worryingly arrogant.

2/ The statement pre-emptively accuses pwme of abuse, before any abuse has been identified. Reads like smearing.

3/ Sarah Tyson's offensive statements on this forum I would class as abusive. So really, the 'warning' looks like victim blaming, and silencing.

DARVO.

.

.

 

Would it be possible to develop core outcome measures according to the class of expected benefit? E.g. on PEM, on exercise tolerance, on pain, etc.?

 

Much better to let them put their silly disclaimer then experience *absolutely zero abuse*

 

Perhaps it is meant to keep Tyson in line and stop her further abusing members of the patient community?