1951 study

[biopearl]

Fisher, I would like to ask your opinion on what seems like an inconsequential update noted in the 1951 Mayo study on clintrials. Just some dates have been changed but nothing substantial e.g. length of study, top line reporting etc. I can't make sense of it and why it appears warranted. Could it have relevance to when the data is (or was) submitted to the FDA for something like BAT etc. ? Maybe it is just a routine administrative thing but I wondered if there was some inference to be gleaned. Thanks, bp

[Fishermangents]

Bio, you raise a very interesting point. I will take a closer at this later, as I am a bit in a hurry. For now I see three significant changes:
- duration from 3 to 5 years
- the definition of the study-end is changed
- they skipped the wordings 'unacceptable toxicity' and changed it into 'as long as they derive clinical benefit'
The whole thing looks more confident and positive. It also seesm to me that they don't expect toxicity as a reason to end the study, probably becasue they can manage it. However, this requires further study. I agree with you that these changes are reflecting a change in their attitude, to my opinion a more positive one.

[biopearl]

Fisher, the changes you cite to my reading are old news from the last November update which was exciting indeed and extended the study as you point out with the changes you also mentioned. But that happened in November. Now there is a very brief and new and to my eye nebulous update I am tying to understand. Regarding the prior November changes, the time extension is really something to note since many high risk patients would have been expected to have not survived for that period, so clearly they hope to demonstrate survival benefit along with the other end points such as drug approval in the US. Now that was a significant update. This latest one not so much, unless I am missing something subtle, hence my question. Thanks and Regards, bp

[Fishermangents]

Hi Bio, I will get into it later today, as I am a bit busy right now. Btw: changes on the CT site are not just administrative matters. Changing texts have a good wellthough off reasoning behind. Let's see if we can get a grasp of the wider meaning of these changes.