“a large, highly representative electronic data infrastructure for conducting clinical outcomes research. Specifically, this program will promote a more comprehensive, complete, longitudinal data infrastructure”
If there’s anything the chronic fatigue syndrome community could use right now is a break with clinical trials. The two most salient facts about clinical trials and ME/CFS is that a) they’re darn rare, and b) they should be common given the size of the community, and the many different treatment options people with ME/CFS and their physicians employ.
A community effort to produce the best possible clinical trials for ME/CFS
At the FDA Stakeholder meeting one speaker bluntly said neither researchers or drug companies are interested in chronic fatigue syndrome but then pointed a finger at the audience and said “If you build it they will come…They always do”…
And here we are – with a chance to build it
Presented with a chance to support an ME/CFS clinical trials network, Health Rising partnered with nine other organizations (Race to Solve CFS, CFIDS Self Help, CFIDS Association of America, CFS Knowledge Center, Fibromyalgia-ME/CFS Support Center, Inc., Massachusetts CFIDS/ME & FM Association, OFFER, PatientsLikeMe, Rocky Mountain CFS/ ME & FM Association and Speak Up About ME) to lay the groundwork for one.
Lead by the CFIDS Association of America, these organizations will complete for $12 million to fund to up to 18 “Patient-Powered Research Networks”.
According to their website, the Patient Powered Research Networks program will build “large, comprehensive electronic databases that give patients and doctors input into clinical research”. One of PCORI’s major outcomes – “highlighting the comparisons and outcomes that matter to people” – might have been very handy six months ago.
TAKE THE FIVE QUESTION SURVEY
One wonders if Ampligen would be available to ME/CFS patients today had PPRN documented the ME/CFS communities willingness to try the drug. The panelists who voted for Ampligen felt that ‘given the needs’ of the ME/CFS community that Ampligen should have been made available. Two votes (say, Dr. Komaroff and Dr. Unger) were all that stood between the approval and rejection of that drug.
According to the PPRN website, this program creates “a large, highly representative electronic data infrastructure for conducting clinical outcomes research.” That ‘highly representative’ part is why every organization and every person with ME/CFS should join in this effort. This only works if a broad swath of the ME/CFS population is involved.
TAKE THE FIVE QUESTION SURVEY
The PPRN produces an electronic data network that will include patient and physician input and facilitate more clinical trials for ME/CFS.
Health Rising is proud to work with the CFIDS Association of America to bring clinical trials for ME/CFS a step closer. The next step in the process is gathering data from the patient community. This is an important step as it will show the PPRN judges the community supports the effort to get produce clinical trials. Simply completing a quick 5 question survey will accomplish that.
Please fill out the survey here and bring us a step closer to building our own Clinical Trials Network. Let’s get rolling on bringing more treatment possibilities to the ME/CFS Community.
The time is ripe for something like this to happen in the ME/CFS Community.
- If you read the Roundtable Report with Simmaron you know our physicians are bursting with treatment ideas and want to test them.
- If you followed the FDA Stakeholder meeting you know Dr. Peterson and Dr. Klimas told the FDA they and the ME/CFS physician community are ready now to produce large, networked clinical trials.
- If you’ been paying attention the past couple of years you know that despite two successful Rituximab trials, no US trials exist for this possible breakthrough drug.
- If you’ve been following this blog you know new or unstudied possibilities (aka, Vistide, high-dose B-1, IVIG, etc. ) are popping up all the time.
- If you’ve been watching the CFIDS Association of America, you know their drug repurposing study suggested that two drugs, used together, could make a difference in ME/CFS.
- If you kept up with the FDA you know they declined to approve a drug, Ampligen that the ME/CFS community and its doctors (including those who’ve used the drug) strongly embraced.
TAKE THE FIVE QUESTION SURVEY
From the CFIDS Association Announcement:
“The CFIDS Association has partnered with 10 other ME/CFS and Fibromyalgia organizations to compete for $12 million that will fund up to 18 Patient-Powered Research Networks. These Patient-Powered Research Networks will serve as the basic building blocks for a National Patient-Centered Clinical Research Network.
This is a tremendous opportunity for the ME/CFS and Fibromyalgia community to ‘mainstream’ ME/CFS & Fibro research and will attract the best and brightest investigators. If awarded, it will give us ample opportunity to participate in ME/CFS and Fibromyalgia research and enter into the conversation about the types of research that should be done.”
Part of our application requires that we describe some basic aspects of our community. Please take a moment to answer the 5 questions of this survey. Your responses will help our application be the best it can be. Thank you!
The link takes me to SurveyMonkey which asks a lot of personal questions. Is there a way I could go directly to the 5 question ME/CFS survey?
That is the ME/CFS survey; it asks about gender, race, age, how many people in your family have ME/CFS and how you want to contribute. All the answers are aggregated – no one knows your individual answer – if that helps; note that it does not ask your email address, name, etc. – so your answers can’t be tied to you.
Is this for US residents only?
My guess is that it is..Maybe someone who knows better can answer.
My screen thanks me for completing the survey. All the links in your article do the same.
Is it possible you already completed it Suella? I did, through the CFIDS Association site.
That was easy!! Thank you Cort for all you do.
Hi, Cort,
I’ve taken the survey, but I have two queries. First, is it for US citizens only? I ask because I ticked that I am willing to participate only online. The question only gives one reason for that, namely that one is too ill to participate in person, whereas my reason is that I live in Australia. There was no opportunity to say that.
regards, Lynne
Cort,
What are the two drugs that CFIDS is talking about working together?
Thank you!
They’re still a secret! All we know is that extensive research at Biovista suggested that two drugs not usually used together in this disorder, might work. The research also suggested that other drugs commonly used in ME/CFS might not be so helpful.
The CAA is planning to do a clinical trial on these two drugs. If I remember correctly they wanted to get that set up first (???). I think we’ll know pretty soon what the drugs are, though.
Cort,
Is this the same survey I filled out a week or so?–link was in an email from CFIDS. I worry about the surveys being criticized because some of us may respond more than once if we’re not careful. There was one a while back where I really couldn’t be sure I hadn’t already filled it out. Is there a mechanism for preventing duplications? I’d like to know so I could go ahead and take all the available surveys!
And, I’m also very interested in the answer to Cheryl’s question above about the two drugs taken together that showed good results.
Thanks for everything!
Please can you check the survey links? It tells me ‘Thank you for completing this survey’. I don’t remember having filled it in, perhaps I did.
I looked on the CFIDS website for the information on the two drugs taken together that showed good results and couldn’t find anything. Any info on these two drugs would be great.
Thanks
My guess is that we’ll know in the next four months or so. As I remember they wanted to get something set up first. This project could help set up the structure to produce the clinical trials on these drugs.
A central place to report anecdotal evidence – such as trying B1 or Align probiotic (both of which I’m trying now) – would be a useful addition.
Researchers would be able to see if the anecdotal evidence from a group of people points to any trends that might need studying further.
It isn’t particularly scientific data – but most people swear by what they have figured out works for them. Many of these self-discovered protocols are too complicated to be of use, but some, such as the results from people who are taking a single thing, or a very small set of medications and supplements – is still data.
There is NO place to put it right now.
Thank you for a wonderfully written article on this Cort. You connected all the dots beautifully, as per usual.
FYI to all those helping us by completing the survey – it is set up so that any given computer can only take the survey once. If you are getting a “Thank you for filling out this survey” message”, you or someone using your computer has already completed it. If you answered the survey from the CFIDS Association email or Facebook link, this is the same survey, so no need to do it again.
This small slice of data is one small piece of a rather large application – but it is an important one. Thank you to everyone for their assistance.
hello I write this with a translator sorry for the mistakes
I and my children and my friend have ME CFS FYBRO a spasmodic waare hell ignoring gene get your hearing and you still bods on a wall family friends declare you crazy
controleartse treated like a dog
my eldest son committed suicide from the pain and fatigue
my youngest son has no school no work no friends nothing
I am disabled by this terrible disease and not much more
I gotta say we have said thank god good doctor
and our proff the meilleire kenny is supper for us
I hope something comes soon for all our people
it is certainly not between the ears is really a disease
with us it started with a grip vierus
grt to everyone there
A whole family! Wow. Good luck to you Patricia and hang in there…I think we’re making progress.
Even though I was diagnosed by Dan Peterson over two decades ago and having had ME/CFS/FIBRO, it is so disheartening because I live no where near him, Dr.’s Klimas nor, Dr. Enlander. Also because I am SSDI, I can’t afford to trave lto any of their locations; thus no treatments, no trials, no ANYTHING. After 33 years of this illness dictating my life, I am nowhere closer than I was 33 years ago. I am exhausted trying to teach the medical caretakers about this and being told that they could refer me to some counseling, and/or dealing with their frustrations in trying to help me. Anyone out their, Cort, that can give me further direction?
I’m working on something that should help. It’ll be a few months…
Hi all,
To answer the question about whether this is for US citizens only, I filled out the survey ( 5 questions) and I live in Canada. It accepted it and thanked me so I assume not being in the US is OK.
Claire from Ottawa, Canada
I still haven’t seen any reply as to whether the trials are only for US citizens.
Wow, this research network sounds very promising! I’ll definitely want to look into it a little more. I am not going to pretend to be an expert in this area, and this blog has become an amazing resource for me. Hopefully early engagement with the survey has been promising!