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Biotech / Medical : Indications -- Cancer -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (326)	12/18/2002 7:52:09 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 1840

>> The agency believes that it is timely to move toward an emphasis of interim analysis of a surrogate endpoint in a randomized trial rather than relying on nonrandomized phase II trials. << Yes!!! Yes!!! Yes!!! Given this, what excuse will the crap companies have, going forward, for these miserable "historical control" phase IIs? Design a DECENT phase II trial with sufficient power, and the rewards could be substantial. Yes, yes, yes!!! >> They are encouraging a greater use of time to progression rather than tumor response as an endpoint for agents being evaluated under accelerated review. << A "response" can lead to a huge benefit in "quality of life" terms. Seems to me that time to progression should be standard for diseases where metastasis is an issue, and that compromise could be otherwise reached. In general, I am soundly behind FDA on this issue. We had a bunch of crap companies trying to limbo under high hurdles rather jump them.