The response to our call for progressive and other MS’ers to watch this video and complete the survey has been surprisingly poor (14 respondents so far). It makes me wonder about all the complaining progressive MS’ers do in relation to there being no treatments for progressive disease and the lack of research. Without a clear signal from you that you are prepared to have lumbar punctures as part of a clinical trial the less likely we are to be able to test this study design, which I think is very innovative.
In addition, it is an output of the Promise 2010 programme. Many of you complained that this programme did not deliver on its promise. I disagree! The Promise 2010 programme was a partnership between MS researchers and MS’ers; we need you to help translate the insights from the programme.
In addition, it is an output of the Promise 2010 programme. Many of you complained that this programme did not deliver on its promise. I disagree! The Promise 2010 programme was a partnership between MS researchers and MS’ers; we need you to help translate the insights from the programme.
If you are willing to help can you please watch the video above before completing the survey
; questions in the survey relate to issues presented in the video: MS LP Survey.Thank you.
Is there a deadline by which you'd like this survey to be filled out?
Maybe people who don't want LPs are not doing the survey or not even watching the videot want LPs are not doing the survey or not even watching the video
I'm staggered at the apathy of people who read the blog. This approach to testing of potential cures strikes me as being revolutionary – give it a go
I think the exclusion criteria for your trial Prof G means a lot of us PPMS'ers are ineligible.I was put on Mitox 2 years ago because the consultant felt that it was worth a shot. It failed and now I can't participate in your trial.Trust me, progressive MS'ers are desperate for effective treatments.If others are not responding to your survey the perhaps it's because they fall into the exclusion zone and are disheartened.
Prof G, maybe it's because you have fudged your talk?Your proposed study apparently takes two years and the current trials take seven. However, the seven years includes 1 year registration and 1 year data analysis. You seem to have shortened data analysis to 6 months and registration is not on there.Why would you do the fudging? You are trying to sway us to vote yes to get money (where from I wonder). You state your grant got turned down but also say this was part of promise 2010. Why did you not do this as part of promise 2010 when the NMSS gave you millions of dollars? Why should you get more money when you didn't do anything with it last time?I'm disappointed in you Prof G!
Dear All There is no exclusion criteria for this, as it is a question of personal opinion. At the moment this is not a trial you can to be excluded from, so no need to be disheartened. The essential question is would you be willing for three LP or Not?If not I urge you to say so and if so, I urge you to say so also! I have no CoI in it being positive of negative, but the worse response is apathy. This will help inform Prof G on the prospect of success, or not, in recruiting people to a study
If there's no deadline I can circulate the link in the next of the newsletters I compile, however it won't be out until December. Is that too late?
Re: " you fudged your talk? Your proposed study apparently takes two years and the current trials take seven. However, the seven years includes 1 year registration and 1 year data analysis. You seem to have shortened data analysis to 6 months and registration is not on there."The assumption is that the larger study is a phase 2b/3 study; it takes a some time to complete all the data queries and close the data base after a 3 year, multi-site, 600 patient trial. A 12 month period is typical for this size study. If it is a phase 3 study it may be suitable for submission and licensing, but the FDA and EMA typically want 2 phase 3 studies for licensing. This is why most pharma companies run two trials in paralllel. Fast-track approval takes 6 months from time of submission and a regular approval process will take 12 months. If when the green light is given to license a drug it takes some time to come to market. The CSF study is a phase 2 study and cannot be used for licensing; it is a proof of concept study and the data will be used as a go no-go signal for larger phase 3 studies. The problem at the moment is we don't have a quick phase 2 study for neuroprotection. The data analysis only takes 6 months for logistic reasons; 60 patients and a biomarker primary outcome. Re "Why did you not do this as part of promise 2010 when the NMSS gave you millions of dollars?"We did; our research on neurofilament as a biomarker in MS as part of the Promise 2010 Programme is what underpins this study design. And our work on neuroprotective agents in our animal model of MS has provided us with the drug candidates we want to test in our trial. Without the Promise 2010 programme we wouldn't necessarily have the insights or the compounds we have now. You have to realise that we didn't know back in 2005 when the programme started what we know now. So yes, Promise 2010 was a success.When you apply for a grant you typically have to predefine the studies your intend doing. Promise 2010 was no different, we didn't propose to do a trial as part of the 5-year programme. Two neuroprotective trial designs came out of our work; one is funded and is about to start testing phenytoin in acute optic neuritis and the second is the spinal fluid neurofilament trial. Re: "Why should you get more money when you didn't do anything with it last time?"At least now we have a better idea on how to test neuroprotective strategies in MS, we have excellent animal models to screen neuroprotective drugs and a list of candidate compounds for testing in MS'ers. I hope I have convinced you otherwise.
Dear AnonYou are way off the mark, because you have not done your homework on what Prof G was funded to do in promise 2010! It was not to perform clinical trials, but to find markers of progression.This trial design uses that marker. As such the analysis is a lot less complicated than in a conventional trial so analysis is quickerYou have can see the potential CoI in the result, this is your chance to torpedo it if you feel that way. However answer honestly and inform us..that's all Prof. G is asking.
I think the poor response is just down to people not knowing about it. You need a better way of communicating with the MS community so that all sufferers of MS know about these kind of surveys and help they can help you guys to help themselves. You need to be able to mail people directly, instead of them stumbling across the info (I only just found out this blog existed).
Re: "You need a better way of communicating with the MS community so that all sufferers of MS know about these kind of surveys and help they can help you guys to help themselves. You need to be able to mail people directly, instead of them stumbling across the info (I only just found out this blog existed)." The main purpose of the blog is to communicate with MS'ers. This is why it was started. If you have any ideas to get the blog advertised we would appreciate your help.
Prof G thanks for your explanation. You need to change the video otherwise you are lying to us- the 7 year vs 2 year comparison are two things that cannot be compared.
Re: "Prof G thanks for your explanation. You need to change the video otherwise you are lying to us- the 7 year vs 2 year comparison are two things that cannot be compared."Maybe. But I still believe they can be compared; both are phase 2 trials. The current CUPID study testing TCH, the active ingredient in cannabis, as a neuroprotective agent in progressive MS will have taken longer than 7 years by the time it is completed. The question is whether or not the EMA will allow the drug to be licensed, if the trial is positive, on a single study or will require a second study. If the former the current trial will be labelled as being a phase 3 study (pre-registration) and if the latter a phase 2 study. The point I am trying to make is that our current phase 2 neuroprotective study designs that are based on clinical or MRI outcomes take many years to do and that a CSF biomarker study will speed up drug testing. To achieve the latter we need people like you, if you are an MS'er, to agree to have LPs as part of a trial. If not we are stuck with the status quo. If you are prepared to come out of the closet why don't you join me and we can make a new video together.
I posted about thie on the MS Society Forum in the hope of drumming up interest. Maybe it is worth posting on FB as well – I would have to leave that to someone else. Twitter? To publicise what sounds like, to me at least, a really good idea 🙂
Link would not work for me, so could not complete questionaire
Re: "Link would not work for me, so could not complete questionaire."Try the following: https://www.surveymonkey.com/s/5JV6723
Sorry to be blunt, but I think it may be in the wording of your explanation.It took me a while to ascertain that you are looking for opinions from all types of MS patients, and not just progressive MS.Also, it's not immediately clear that you are at this stage just looking for opinions and not people to take part in a trial yet.
Thank you; the response rate has increased rapidly. There has now been 51 responses to the survey. Interestingly two people got the animal and the musical instrument incorrect, which implies they didn't watch the video.
Re "It makes me wonder about all the complaining progressive MS'ers do in relation to there being no treatments for progressive disease and the lack of research."Seiously Prof G, please never doubt the eager need us folk with progressive forms of MS have with regards to effective treatments. It's so important for you and your team not to lose sight of this.
Agree with the comment above about the wording. I've been advertising the survey on FB groups etc and the feedback I've had has been that people think it's asking them to take part in a trial or it's only for PPMS'ers. Despite the blurb I added explaining to the contrary; when they actually read the survey the wording can be a bit confusing! Glad that the response rate is increasing though. Will continue advertising!
Not sure how many people pass through your clinic each weer, but I'm guessing maybe half have progressive MS. Why not hand out a photocopy of the background to the need for volunteers – get the to read the page and indicate whether they would / would not be prepared to have three LPs? Why not write to those who were on the Lamotrigine trial providing the link to the survey. Why not e-mail 10 neuros and ask them to provide their progressive patients with the link? I suspect that not that many progressive patients visit this blog. MS nurses will have more contact with progressive patients – use them as the middleman for making the contact?
I would guess that the lack of response correlates with the lack of publicity as well as the short length of time that you have been soliciting responses.Just like clinical studies, it takes time to recruit people to respond to these inquiries. A bit of patience might be in order while we spread the word about your needs for subjects. I'll work on getting the word out if you work on being a bit more patient waiting for a response. There is interst out here in helping.-L