since a long time I'm looking for data in RRMS about the average...
- annualized relapse rate
- annualized new MRI lesions
- annualized change in EDSS
I also asked my neuro about that but he didnt know.
I'm aware of the fact that in RRMS these parameters may change with dissease duration (e.g. 1 or 15 years from diagnosis), age or sex.
So a reasonable way would be to gether these infomation for a variety of groups (age, sex, etc).
Does anyone of you have any data on that subject?
One curious example was a phase-II laquinimod study where in the placebo group the annualized new MRI lesion count was 9,6 (way too much). I guess the average might be around 1,5 - 2.
Just for example these two different placebo groups (9,6 or 1,5) would shed a completly different light on a drug in trial that reduces the lesion count to, lets say 0,9.
In the fist case its less than 10% of the placebo count in the second case
its sill more than 50%.
I think it would be very important to know about the average values, to evaluate the outcomes of a certain drug-trial.
http://www.msif.org/en/news_press/news/ ... atien.html
Trials have a placebo arm for that specific purpose. Comparing the non placebo arm of a trial to the average general population, I don't think would be scientific, as it does not take into account the placebo effect. Also, most trials have/provide the statistics regarding their effectiveness.Frank wrote:I think it would be very important to know about the average values, to evaluate the outcomes of a certain drug-trial.
For example if the placebo arm in the study shows a much higher rate (eg lesion count) than the average of an untreated comparable cohort, then this would be suspicious.
How should statistics deal with this problem?
Apart from studies it would be interesting for MS patients to know how severe their MS course is.
To give one example:
If you knew that a matching average patient - eg. interferon treated male RRMS patient, age 30, dissease duration 5 years - has an average relapse rate of 2 per year and you have 4 relapses per year you might want to talk to your neuro about a change in your therapy.
Unfortunatly they do not have the data I was looking for.
Still they have a statistical tool online that gives everyone access to their database. Which can be found here.
For my personal use I found the output diagrams a bit hard to read and the data was not that useful...
From memory after I did this research myself many yrs ago I think I recall the averages of "untreated RRMS" were something like 1.2 relapses/yr, 3-5 new non-enhancing lesions/yr, and +0.5 EDSS/yr.
It might be helpful to grab the clinical trial data for each of the CRABT drugs and look at the control arm statistics.
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Last post by Kheuer
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