Saturday, March 04, 2017 5:04:46 PM
biosectinvestor,
Thanks for your responses. They coincide with my view that FDA will always push for a company to or themselves make an announcement of a finding of futility for the sake of patients and their doctors to make informed choices. The reason patients agree to join trials in the first place is to have the opportunity to perhaps receive a better treatment than SOC. As AVII77 says, futility does not necessarily mean that the treatment does not work but I believe that regulators want patients to always have the right to know, at the earliest appropriate time, what the futility situation is so that they can make their own best informed choice. I believe that clinical trial guidelines specifically point to this and that this is the most ethical way to proceed.
The examples given, in this thread, of trial patients being followed after futility was announced was precisely because there was a public announcement of futility. While there well may be companies that tried to hide or otherwise firewall themselves from futility findings, I would venture to say that most would get or have gotten into very hot water for attempting to do so and is also the reason why FDA can intervene to announce it and will if an ethicist from the DSMB approaches them about it after having informed the company or their representatives first. Best wishes.
Thanks for your responses. They coincide with my view that FDA will always push for a company to or themselves make an announcement of a finding of futility for the sake of patients and their doctors to make informed choices. The reason patients agree to join trials in the first place is to have the opportunity to perhaps receive a better treatment than SOC. As AVII77 says, futility does not necessarily mean that the treatment does not work but I believe that regulators want patients to always have the right to know, at the earliest appropriate time, what the futility situation is so that they can make their own best informed choice. I believe that clinical trial guidelines specifically point to this and that this is the most ethical way to proceed.
The examples given, in this thread, of trial patients being followed after futility was announced was precisely because there was a public announcement of futility. While there well may be companies that tried to hide or otherwise firewall themselves from futility findings, I would venture to say that most would get or have gotten into very hot water for attempting to do so and is also the reason why FDA can intervene to announce it and will if an ethicist from the DSMB approaches them about it after having informed the company or their representatives first. Best wishes.
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