RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Sad newsThank God for that!
In all such matters related to early cancer trials, the people putting them together make their best guesses and soldier on through the variable responses. TH-1902 is blazing a new trail and the chances that the trial design will later be deemed to have been absolutely perfect for the situation are pretty low. If they got it generally right, that should be good enough.
If TH is having a cancer KOL event on 6/21, it tells me there is a god chance they already know they have gotten enough rght with the early part of this trial to give them confidence to tell us about it. We have a week and a half to wait until we hear what they have decided to share with us but it likely is going to be mostly good news. Otherwise, we would just get a terse PR telling us the trial had to be stopped for safety or other reasons.
I don't recommend stressing too much over this stuff until we hear what they have to say on 6/21. We are only getting very infrequent and random data points so we really have very little idea about the status of the trial.
juniper88 wrote: I don't believe it is easy to make that distinction. I believe you are right why the trials ask for mininum 3 months. My point was that if you do make it longer than even more patients would not get the experimental treatments at all. Ethitics is kind of a difficult thing in this situation.
Btw, my wife was told in 2019 she had less than 1 year to live. Obviously, their estimates are not always right.
qwerty22 wrote: Can you make that sort of fine distinction between 3 and 6 months? Presumably if a certain cancer at a certain stage has a life expectancy of 6 months then within that statistic there are some people who will hold out for 9 months and some that will succumb in 3. Is it possible to predict which path an individual patient will take? It seems like the life expectancy criteria is just to rule out people who have entered the very final end-stage where vital processes are beginning to be impacted by the cancer.
From my limited experience of cancer it seems pretty obvious when the cancer has started impacting vital processes and the person enters the final phase, mercifully often very rapid, precipitous descent. Prior to that a person might maintain some stability to their general health even though the cancer is growing.
juniper88 wrote: Thera could have specified a 6 month life expectancy instead of 3. Then a person with that life expectancy would more like have gotten a therapeutic dose. However, Mr. Snyder who's life expectancy was probably less than 6 months would never have been on the trial.
I believe right now any new patients would be getting a therapeutic dose.
scarlet1967 wrote: They need to increase the life expectancy as it is now the therapeutic benefits of their drug absent any toxicity could start at forth cycle or later each cycle takes 3 weeks a total of minimum 3 months before any potential efficacy so these patients won't see any benefits due to a narrow window for the drug to work.
In my opinion as per current design few first patients who enrol pretty much are contributing to the trial process but not getting any meaningful benefits and yes we should thank them for their heroic contributions. I am not an expert but this doesn't add up, not ethical at all.