NIH short, medium & long-term plans/Vicky Whittemore IACFS/ME slides

[Simon]

From Mariam Emr, On behalf of the Trans-NIH ME/CFS Working Group

The slides from the NIH presentation at the IACFSME meeting in Ft. Lauderdale, Florida have been posted. You can view the slides at https://www.nih.gov/sites/default/files/research-training/initiatives/mecfs/whittemore-presentation.pdf

Short version (my take)

Long-term (FY18-22) it's much as you'd hope

Ultimately, to improve the quality of life for all individuals with ME/CFS
Support the development of new therapies and treatments for ME/CFS [via new Collaborative centres and efforts to speed the process from bench discoveries to bedside treatments]

Though I'm a little disappointed that new RFAs doesn't seem to be a priority til then "Develop new RFAs as appropriate" as current RFA plans are around building infrastructure and research capacity, not directly funding studies.

Medium term (FY17-18)

• Trans-NIH CFS/ME Working Group developing an extramural research program to support studies on the cause, prevention, diagnosis, pathophysiology and treatment of ME/CFS

Well, that certainly seems to be the meat of it, though it's not at all clear this will involve RFAs to spur research until they are 'considered' in 2018.
Also:
• Encourage Investigator-initiated grants submitted through parent grant announcements [ anyone explain this??]
• Encourage submission of applications from young investigators to develop pipeline of investigators

Also

• Work with FDA to develop clearly defined endpoints for treatment trials and interventions
  
• Develop mechanisms for access to available biospecimensfor potential identification of biomarkers
  
• Launch ME/CFS Collaborative Research Centers and ME/CFS Data Management and Coordinating Center
  
• Foster and develop international collaborations and partnerships to foster ME/CFS research
  
• Assess clinical trial readiness and potential treatment and intervention trials for ME/CFS
  
• Leverage CDC health care provider educational materials

Short-term included the request for information to help establish research priorities (which will presumably be announced at some point)
- and focusing on "Common data elements" for all studie (a CDC priority too), which will help multiple centers work together in building longitudinal cohorts. I hope these will include developing one for PEM, whih hasn't yet been defined well by anyone (as a questionnaire for patients).

I thought this was quite promising overall, and a long way forward from where things stood a couple of years back. But read the slides yourself and make up your own mind.

 

[dreampop]

Overall you can see the emphasis is to create structure where it doesn't exist. It does seem to be a long, kafkaesque approach to do that but that seems inevitable with a trans institute working group. Btw, is Walitt not on the working group anymore or was he never? Kinda shocked Nath's study still hasn't really gotten underway.

 

[BurnA]

Yeah I wonder how old these slides are ?
Overall nothing very revealing. Would like to see a commitment of a dollar amount in research in the long term.

 

[viggster]

Overall you can see the emphasis is to create structure where it doesn't exist. It does seem to be a long, kafkaesque approach to do that but that seems inevitable with a trans institute working group. Btw, is Walitt not on the working group anymore or was he never? Kinda shocked Nath's study still hasn't really gotten underway.

Walitt was never on the working group.

Nath's study is running healthy controls through the protocol now. And the clinical center has been calling ME/CFS volunteers for pre-screening. Here's what Nath said on the Nov. 2 NIH conference call:

"Dr. Avi Nath: All right, so we have been working very hard in getting this protocol up and going. It’s a very complicated protocol with lots of different arms to it. So it’s taking us a little bit longer than we thought to get started. But nonetheless, we have now and it’s open for enrollment.

We have brought in two healthy volunteers to the Clinical Center for that purpose. One is currently here at the moment and one we had the last week. And then there are a few more lined up to come.

And then starting early next year sometime we’ll start getting the patients with chronic fatigue syndrome, ME/CFS patients. We decided to go with the healthy volunteers first because we wanted to make sure we ironed out all the kinks before we bring in patients who are actually sick."

 

[viggster]

Yeah I wonder how old these slides are ?

From the IACFS/ME conference in late October.

 

[BurnA]

From the IACFS/ME conference in late October.

Yeah thanks, I know they were presented then, but i just wondered if they were prepared earlier perhaps for some other presentation and then re-used. Maybe not, but it just seemed like some of the info could be considered old.