Status of current and past Rituximab studies

[EtherSpin]

I hope (if its true severe cases respond less) that they will simply need more infusions or perhaps some exercise in tandem with the treatment (as severe cases *will* have massive deconditioning Id assume) and maybe supplements and other augmentation with complimentary meds to ensure disrupted systems can kick back to life

 

[greeneagledown]

It sounds like we're looking at a final publication date around or close to July/August 2018, assuming the final patient starts treatment around this September. That's 2 years for all the patients to complete treatment and follow-up, 6 months for F&M to prepare a manuscript (I don't have a great feel for how long it takes to prepare a study write-up for submission, but I'm assuming this will take some time considering that there are multiple sub-studies), and then 4-5 months from when they submit the manuscript to when it actually gets published (which is consistent with both of their previous two Rituximab publications).

In short, 2 years from around September for the study to finish, then another 10-11 months to analyze the data, prepare a manuscript, and get it published.

Might not be precisely correct, but it should be in that ballpark.

@deleder2k, does that sound about right?

 

[deleder2k]

@greeneagledown, I really don't know.

Your reasoning makes sense. I do not know how much time they need to complete the study. For the sub studies I think that they can be completed or almost completed before 2 years of follow up since they are conducted after or around 10-15 months.

I don't know if they need to wait 4-5 months to have it published. Maybe they will publish in another journal if the study turns out positive? I guess they would rather have it published in New England Journal of Medicine or The Lancet rather than PLOS ONE. Could a study of this magnitude lead to that it is given "fast-track" status in a journal? I guess @Jonathan Edwards knows all there is to know about the timeframe of conducting and publishing a study.

 

[greeneagledown]

@greeneagledown, I really don't know.

Your reasoning makes sense. I do not know how much time they need to complete the study. For the sub studies I think that they can be completed or almost completed before 2 years of follow up since they are conducted after or around 10-15 months.

I don't know if they need to wait 4-5 months to have it published. Maybe they will publish in another journal if the study turns out positive? I guess they would rather have it published in New England Journal of Medicine or The Lancet rather than PLOS ONE. Could a study of this magnitude lead to that it is given "fast-track" status in a journal? I guess @Jonathan Edwards knows all there is to know about the timeframe of conducting and publishing a study.

I'm guessing the inclusion of substudies during the study will mean that the post-study analysis takes a little longer. I don't think they'll start analysis until the whole study is done. I bet they'll want to see, for example, whether people with improved endothelial function at 10-15 months are more likely to still be in response at 2-year follow-up.