Replies to post #2083 on Biotech Values

[rstor1]

>> Makes you wonder if you could use the same trial to run two or more NDA's - one for all brain cancers, one for breast->brain, one for lung->brain, etc. <<

If the bifurcation is done retrospectively, it’s the same problem all over again, so the short answer is No.

But have you ever seen it done prospectively?

Would the FDA not allow it?

It seems that if you could choose a couple of likely subgroups in the context of the larger trial, youy might have some additional filing expenses, but you might save the cost of additional trials.

[Biowatch]

>>ex post facto analyses<<

I think there was concern about "subgroup analyses in clinical trials" at the ODAC meeting on RSR 13. I did not see it, but there was a presentation by this title there, given by Stephen George, PhD, Director of Biostatistics at Duke.

The last slide concluded:

>>
- Pre-planning is key
- Larger studies required for proper subgroup analyses
- Exploratory analyses are good for hypothesis generating but are not convincing alone
- More than one study important for validation
<<

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Searching on "George SL" at PubMed turns up some interesting articles,
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

including articles on accelerated approval and whether statisticians on data monitoring committees should be independent of clinical trial sponsors.

http://jncicancerspectrum.oupjournals.org/cgi/content/full/jnci;95/18/1351