“Why else would they do it? Again, this notion t
Post# of 154033
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Posted On: 12/26/2020 10:29:24 PM
“Why else would they do it? Again, this notion that the FDA couldnt ask the DSMC how it's going is just obsurd.”
I stand corrected. The FDA can indeed contact the DSMC to inquire about the trial, but the FDA does have to contact the company in order to do this. Additionally, the FDA notes that this happens in rare circumstances and it sounds like safety is typically the reason, not efficacy. Personally, I still don’t believe the FDA has seen the data. If they had in fact seen the data, noted efficacy equivalent to imminent approval (as many suggest) and made a recommendation, it would be for an EUA application, not for EINDs and to apply for open label extension. And if the FDA had contacted CYDY about communicating with the DSMC, NP would’ve told us about it as he PRs everything (2 anecdotal stroke patients), including communication with the FDA (reference numerous PRs about phone calls and meetings with the FDA).
https://www.fda.gov/media/75398/download#page36
7.2.2. FDA Interaction with DMCs
In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decision- making. An example might be a situation in which FDA is considering a marketing application in which a safety issue is of some concern, and the sponsor has a second trial of the investigational agent ongoing. In such a situation, we might wish to be sure that the DMC for the ongoing trial is aware of the existing safety data contained in the application and is taking those data into consideration in evaluating the interim safety data from the ongoing trial. In such a case, we could request that the sponsor arrange for FDA to communicate with, or even, meet with, the DMC (see 21 CFR 312.41(a); 21 CFR 812.150(b)(10)), and care should be taken to minimize the possibility of jeopardizing the integrity of the ongoing trial.
I stand corrected. The FDA can indeed contact the DSMC to inquire about the trial, but the FDA does have to contact the company in order to do this. Additionally, the FDA notes that this happens in rare circumstances and it sounds like safety is typically the reason, not efficacy. Personally, I still don’t believe the FDA has seen the data. If they had in fact seen the data, noted efficacy equivalent to imminent approval (as many suggest) and made a recommendation, it would be for an EUA application, not for EINDs and to apply for open label extension. And if the FDA had contacted CYDY about communicating with the DSMC, NP would’ve told us about it as he PRs everything (2 anecdotal stroke patients), including communication with the FDA (reference numerous PRs about phone calls and meetings with the FDA).
https://www.fda.gov/media/75398/download#page36
7.2.2. FDA Interaction with DMCs
In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decision- making. An example might be a situation in which FDA is considering a marketing application in which a safety issue is of some concern, and the sponsor has a second trial of the investigational agent ongoing. In such a situation, we might wish to be sure that the DMC for the ongoing trial is aware of the existing safety data contained in the application and is taking those data into consideration in evaluating the interim safety data from the ongoing trial. In such a case, we could request that the sponsor arrange for FDA to communicate with, or even, meet with, the DMC (see 21 CFR 312.41(a); 21 CFR 812.150(b)(10)), and care should be taken to minimize the possibility of jeopardizing the integrity of the ongoing trial.
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