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Biotech / Medical : Ligand (LGND) Breakout!
LGND 206.36+1.4%Nov 26 3:59 PM EST
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To: aknahow who wrote (28519)3/13/1999 6:19:00 AM
From: Henry Niman  Read Replies (3) of 32384
 
george, Clinical trials are designed to show efficacy (and earlier trials are designed to find optimal dosing). The size of the trial is a function of the difference between treatment groups. Sometimes the data is so good or so bad that an intermediate result will be sufficiently conclusive to warrant halting the trial at an earlier point.

That is what happened with the International Panretin trial. The FDA initially wanted a delta of 15% (15% more of the group treated POanretin respond than the placebo). A size was determined where 15% was well into the statistically significant range. The interim analysis was very strong, so the trial was halted early.

If the end point were patient deaths and the number in both groups were very close to being equal or the delta was markedly greater than expected, then the trial would be halted.

The significance of the delta is related to the size of the trial.

What many investors don't realize, is that size is really not good (large numbers costs more money, and the big numbers are required, because the drug doesn't work that much better than approved treatments). Thus, if a trial requires thousands of patients, that is because the delta is relatively small, and it takes many patients to prove that the small delta is not due to chance.

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