Feb 282005

A very special thank you to those who participate in any kind of clinical trial, and thus pave the way to new drugs being authorized; I am certainly already a major beneficiary of those who have been willing to do that. While there is always the potential benefit of being an early adopter of a new treatment, the reality of the risks was reiterated today as it appears it cost two people their lives. I know with my first exacerbation, and the brutally slow recovery, I would have been willing to go on a clinical trial to hasten my recovery. Now that I am doing well on Rebif I am much more comfortable with other people putting their health, and lives, on the line to try out the latest and greatest treatments. I am very happy that there are those that make the choice to be a test bed for new treatments!

Erik &amp the Smith Family

 Posted by at 6:29 pm

  5 Responses to “Thanks Clinical Trial Participants:”

  1. I’d like to add my thanks, too! We have a few posters on MSWorld that were partipants in the Ty+Avonex trial. I can’t imagine what they must be going through now. All the questions! 🙁

  2. I’ve always wondered if I should have gone into one of the trials. From what I know now about myself, my participation would have been a problem. My apparent ‘remission’ would have skewed the data. The control group or the test group would have gotten a false positive. Glad I waited.

  3. I have to assume that any clinical trial using sound statistical design is going to control for the statistical likelihood of remission in the study population, mdmhvonpa – why would your course skew the data any more than anyone else’s?

  4. Katja: I’ve always had an issue with “Reduces attacks by 33%”. If I have no attacks, how do they know? Do they look for people with a consistent history of attacks? The call for participents I’ve seen usually dont spell that out.

  5. No, they take a control population (let’s say that’s all the people with relapsing-remitting MS) and tot up the number of attacks and the number and size of brain lesions for those people for some period of time.

    Then they take a group of people who (in an ideal world) are a representative sample of the control population, and dose them with whatever’s under trial for whatever time period. After the trial, they tot up the sample group’s number of attacks and number and size of lesions and compare it to the control population.

    So let’s say you’ve got 1000 people in your control group, and amongst the 1000 people the lesion load increases by an AVERAGE of 9 lesions per person over 2 years(these are totally fantasy numbers).

    And you’ve got a test sample of 10 people, and after 2 years on Wonder Drug X, their AVERAGE increase in lesions is 3.

    Now, very simplistically you can say that being on the drug correlates statistically with a 66% decrease in lesion increase over an unmedicated population.

    Obviously you have to use populations larger than 10/1000, and you have to correct for bazillions of other factors, but the upshot is that any single person’s course isn’t the issue, it’s the statistical characteristics of the entire population being studies.

    Let’s say that your study population showed an average increase in lesions of 9.5 per person. You’d probably say that was a statistically insignificant change.

    Did that make sense?

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