Invest in ME/Prof Jonathan Edwards statement on UK Rituximab trial, 30 July

[BurnA]

. We may actually want the trial to start without the people treating the patients, or the patients, knowing what the detailed results of the preliminary study are. This may seem odd (some other member of the team or maybe a sealed brown envelope will know) but we need to try very hard to avoid anything that might flavour expectations of results because assessments of fatigue are subjective.

I know you are very limited in what you can say about the UK trial but I'll ask this anyway ....
Given your above statement Is it possible the trial might start without disclosing or publishing the results of the initial studies ?
And, if the endpoint of the trial is to demonstrate repsonders in a subset, would this mean a potentially shorter trial and follow up than Norway ?

 

[Snow Leopard]

Given your above statement Is it possible the trial might start without disclosing or publishing the results of the initial studies ?

I think this is asking too much, it is not Jonathan's place to answer this at this point in time.

And, if the endpoint of the trial is to demonstrate repsonders in a subset, would this mean a potentially shorter trial and follow up than Norway ?

Does it matter? The results of this trial and the Norwegian phase III trial are most likely to be interpreted together, so either way don't hold your breath until 2017...

 

[BurnA]

I think this is asking too much, it is not Jonathan's place to answer this at this point in time.



Does it matter? The results of this trial and the Norwegian phase III trial are most likely to be interpreted together, so either way don't hold your breath until 2017...

I know, i'm just curious thats all! And i think it will be 2018, AFAIK last patient gets final dose this month, so 2 year follow up followed by 6-12 months for write up and publishing.

 

[Jonathan Edwards]

I know you are very limited in what you can say about the UK trial but I'll ask this anyway ....
Given your above statement Is it possible the trial might start without disclosing or publishing the results of the initial studies ?
And, if the endpoint of the trial is to demonstrate repsonders in a subset, would this mean a potentially shorter trial and follow up than Norway ?

Almost anything is possible. I cannot really say more!

 

[BurnA]

@Jonathan Edwards I read in your 2014 iime conference address that you believed then that the current state of ME research was similar to RA in the 1970s. Do you think it will take 20-30 years for ME to catch up to where RA is today ?

 

[BurnA]

Almost anything is possible. I cannot really say more!

I am going to chance another question although I appreciate how limited any response may be.

The focus to date for the UCL team has been on establishing a biomarker.And I know others are working on this too. In the absence of this work bearing immediate fruit, at some point would it make sense to perform a UK rtx trial regardless?

If a trial were to be successful could it mean people in the UK get access to rtx sooner in which case, biomarker or not some patients might benefit ?

On a similar topic, if a biomarker isn't established by the time the phase 3 results are out, would you imagine the situation where patients just have to take a chance ? ( assuming successful results )
I assume this approach happens with other drugs ?

 

[barbc56]

On a similar topic, if a biomarker isn't established by the time the phase 3 results are out, would you imagine the situation where patients just have to take a chance ? ( assuming successful results )
I assume this approach happens with other drugs ?

I'm not sure what you're saying. It's probably me as I've been misreading things all morning. Sometimes I'm not sure what I'm saying!

 

[BurnA]

I'm not sure what you're saying. It's probably me as I've been misreading things all morning. Sometimes I'm not sure what I'm saying!

I mean they won't know if they are suitable for rtx or not so they would have to decide or take a chance that they might respond.

 

[barbc56]

@BurnA

Do you have to have a biomarker to prove a medication works? I don't have a clue!

Thanks

Barb

 

[MeSci]

@BurnA

Do you have to have a biomarker to prove a medication works? I don't have a clue!

Thanks

Barb

Rituximab is an expensive and potentially-dangerous drug. Knowing whether you are more or less likely to respond could help you decide whether the risk and expense are worth it. Cost-benefit analysis.