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Biotech / Medical : Human Genome Sciences, Inc. (HGSI) -- Ignore unavailable to you. Want to Upgrade?


To: software salesperson who wrote (1072)7/26/2009 9:49:05 AM
From: nigel bates  Respond to of 1127
 
Thanks for posting that.
Interesting.



To: software salesperson who wrote (1072)7/29/2009 8:23:07 AM
From: kenhott1 Recommendation  Read Replies (1) | Respond to of 1127
 
Couple of random comments.

<Is 45% placebo effect typical?
ISENBERG. It's rather high. In RA trials, we see similar a phenomenon. I don't have a good explanation.
HILLSON. I thought the placebo effect is rather high also. It tracks efficacy by time. Lupus waxes and wanes. But again, I am a little surprised by the placebo effect. >

The placebo effect of lupus can be very high. A drug/trial design must take that into account or you will probably bomb given you have to do two trials. Flip it around, pretty decent performance if your drug can handle a 40ish percent placebo response.

<ISENBERG. I want to emphasize one point. HGSI did very well in executing the study. The trial was adequately prepared. Physicians and nurses must be carefully trained. HGSI did
that. Lupus is a complicated disease. It's not easy to standardize the evaluation.>

An extremely important point that was lost on some people. I call it data mgt, my term but like supply chain mgt, to captain/pilot thru the chain, from beginning to end. Sounds easy but not.

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We will need to see more data to figure out more about how this drug works. But make no mistake that patients are motivated and will spread the word if anything works. While docs maybe looking at the finer details, patients are focused on feeling better, anything that is not toxic and make then feel better.