tag:blogger.com,1999:blog-2741672436160438708.post2274173318886507361..comments2024-03-26T12:50:32.070-07:00Comments on Learning from and about cancer (chronic lymphocytic leukemia or CLL) by Dr. Brian Koffman: ASH 2013: Dr Jeff Sharman Discusses the Ideal Design of Phase 3 Trials with Novel Agent versus the Reality in the CommunityBrian Koffmanhttp://www.blogger.com/profile/13250684684103918493noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-2741672436160438708.post-48749684884980612072014-03-01T13:22:30.844-08:002014-03-01T13:22:30.844-08:00As I have experienced, the lack of a crossover is ...As I have experienced, the lack of a crossover is one huge reason for NOT entering into a trial. Especially if you are comparing the drug to a known drug that has little lasting effect. Aren't the Trial patients in Europe a much higher number than in the US?Terry's CLL Journeyhttps://www.blogger.com/profile/07660455460776039971noreply@blogger.comtag:blogger.com,1999:blog-2741672436160438708.post-6523571843350555032014-02-28T16:01:11.981-08:002014-02-28T16:01:11.981-08:00Awesome to get more posts Brian! Miss them dearly...Awesome to get more posts Brian! Miss them dearly and this was a great one.<br /><br />The more I think about it the more complicated I realize these studies are...<br /><br />Morally - If they pick so a low standard of care like Rituxan monotherapy... a virtual placebo and a lame duck with Gayzva taking its spot... it is good to know that the crossover was built-in from the start.<br /><br />Productivity-wise - How productive is it to pick such low hanging fruit as a control arm? I was trying to think of the best therapy to compare idelalisib against when the study began... and I briefly supposed it was FCR. But so many of our relapse refractory CLL folks who can enroll in these studies are poor candidates for chemo based therapies like FCR..as was the case here. Plus, if FCR were the comparison, I would guess the time to approval would be much much longer as it would take longer for idelalisib to prove its relative advantage if the cohort wasn't so filled with pretreated chemo and 17p deleted patients.<br /><br />Its probably going to get more difficult for them to pick the control arm as more therapies get approved leading to more personalized cocktails depending on the CLL flavor someone has contracted. Whats the standard of care then? Going to the lowest common denominator like a monoclonal antibody like Gayzva with a crossover stipulation to the trial drug makes a lot of sense to me in that framework.<br /><br />So I am especially grateful for the post Brian... because in my rash reading of these trial designs, I usually get angry... but by making me think harder about it... you have made me see that they are probably designing the studies closer to right than wrong, although they can never be perfect.<br />Anonymousnoreply@blogger.com