Friday, July 17, 2009

"Hey, Lloyd, let's run a sloppy study": FDA female condom advisory panel

The STD Center visited the FDA advisory panel on the new female condom in mid-December 2008, and a good time was had by all. The FDA makes the transcripts available, though they're somewhat difficult to find. Here is the main site for all the transcripts prior to the current year, and this site is for this year.

My favorite moment is at the very end of this transcript and at the very beginning of this one: Ralph D'Agostino expresses concern about approving devices supported by "sloppy" studies. He makes a very good argument earlier on (right before this quote) that people having difficulties with the female condom might drop out and that could affect the final results, and asks whether they usually impute for missing data and why they didn't do that here. His final conclusion is a policy conclusion:

DR. D'AGOSTINO: Yeah, but what I'm concerned about is that somebody reading this transcript may say, hey, Lloyd, let's run a sloppy study; we already have approval, already have, you know, precedent for it. I think that what we want is just, you know, give an impression that there are better ways of getting interview data. There are better ways of chasing down the dropouts and so forth, and I'm concerned that we're not emphasizing that. I may not differ from the bottom line where we're going. It's just that the signal may be that we have a better, more positive view of the study than we probably should have...I'm not arguing with the final vote, the way the final vote might go. I'm arguing with the sense that this study has more merit than it actually has, and getting that across is what I think we should need to do.

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