To: tuck who wrote (15198 ) 1/11/2005 12:08:36 PM From: kenhott Read Replies (2) | Respond to of 52153 I have looked at Stellar 3 and 4. I have my hunch but what good is a hunch to others? It is not even lunch. My issues with these trials are: a) The obvious assumption that the drug arms must be beating the xyz out of the comparator arms given historical assumptions and b) problems with running a PS2 only late stage cancer trial that includes a whole bunch of small sites. My biggest problem... I just plain don't have faith that CTIC is capable enough to run these trials corectly from beginning to end. For instance, if I were running the trial, I would have an "answer" by now. After all, it is an open trial!! But it took the Pru analyst to ask "Did you talk with the other larger sites like you did with the largest site?" for the CEO to say, hey, you know what, maybe I should do that. Let's look at Stellar 3. Long story short, no one can convince me that CTIC could not have a problem with the patient population. A bunch of numbers are pointing to a potential problem here. Start at the beginning. You have a trial that has a good story drug with good comparator drugs. It is an excellent trial for these sick patients. Investigators are people just like us and they see what these good trials can mean to some patients, one chance for life. You get on, you get the best care. You don't, and if money is the issue, you will get nothing or you can go on a lesser trial like a phase I dosing trial if you don't die first. How nice. Life or death. Now you have a couple hundred sites with a couple hundred investigators making these decisions. How many get through that are not PS2s? Remember, this is a PS2 only trial. You don't get in unless you are PS2. CTIC and the CRO both completed PS2 audits. But what does that mean? People die in these trial at a fast rate. Just checking paperwork is not going to catch anything. Maybe I am right. Which means forget the numbers but pray to the god of randomness instead. But there are three trials... flip flip flip. I hope I didn't let out my hunch, because I didn't bring no lunch.