“13. 14:14 “First one- We can simply add more patients to the Open-Label of CD12 that we have, and recalculate the p-value until it is less than .05. Is this acceptable by regulatory agencies?”
You’re 100% correct, this is what he said. The CD12 Open Label Extension is enrolling patients but it is a completely separate trial than CD12 (see the the OLEs CYDY has for HIV trials). Therefore, it’s not technically an Extension of CD12 (adding to the 394) because that would require a placebo arm (SOC), but I understand now what you were referring to. The CD12 OLE protocol should’ve populated on clinicaltrials.gov by now, but I’m still unable to find it. I cannot explain why the CD12 protocol completion date has been extended to June 2021 and why it clearly says, “recruiting,” which sparks some interest, but the number of patients in the trial has not been updated (still at 394). I expected approval of the CD16/17 protocol by now so maybe the FDA is waiting to see how the 55+ in the OLE trial are doing?
Most OLEs, per FDA guidance, are for safety and not efficacy. This is why NP said, “Is this acceptable by regulatory agencies? I’m not sure,” when referring to simply adding the patients from the OLE to CD12 and recalculating the p value. This scenario NP proposes seems unlikely, but a search of clinicaltrials.gov nets a number of other BP OLE trials with titles such as “safety and efficacy,” so maybe there’s a small possibility.
https://www.fda.gov/media/85675/download
Q28: What is the difference between an expanded access protocol and a continuation or open-label safety protocol?
A28: A continuation protocol describes a trial in which patients are allowed to remain on an investigational drug or cross over to an investigational drug from placebo or active control following conclusion of the randomized phase of a trial. An open-label safety study is an uncontrolled trial (i.e., there is no comparison or control group). The primary purpose of both continuation and open-label safety protocols, in contrast to expanded access protocols, is to obtain safety data on the investigational drug. The conduct of continuation and open-label safety protocols differs from that of expanded access protocols in that (1) participation in open-label safety and continuation protocols is usually limited to specific, named institutions/centers;
(2) participating investigators in continuation or open-label safety protocols are already identified and trained to collect needed safety data; and (3) in the case of a continuation trial, participants are typically limited to those in the original randomized, controlled trial.
You’re 100% correct, this is what he said. The CD12 Open Label Extension is enrolling patients but it is a completely separate trial than CD12 (see the the OLEs CYDY has for HIV trials). Therefore, it’s not technically an Extension of CD12 (adding to the 394) because that would require a placebo arm (SOC), but I understand now what you were referring to. The CD12 OLE protocol should’ve populated on clinicaltrials.gov by now, but I’m still unable to find it. I cannot explain why the CD12 protocol completion date has been extended to June 2021 and why it clearly says, “recruiting,” which sparks some interest, but the number of patients in the trial has not been updated (still at 394). I expected approval of the CD16/17 protocol by now so maybe the FDA is waiting to see how the 55+ in the OLE trial are doing?
Most OLEs, per FDA guidance, are for safety and not efficacy. This is why NP said, “Is this acceptable by regulatory agencies? I’m not sure,” when referring to simply adding the patients from the OLE to CD12 and recalculating the p value. This scenario NP proposes seems unlikely, but a search of clinicaltrials.gov nets a number of other BP OLE trials with titles such as “safety and efficacy,” so maybe there’s a small possibility.
https://www.fda.gov/media/85675/download
Q28: What is the difference between an expanded access protocol and a continuation or open-label safety protocol?
A28: A continuation protocol describes a trial in which patients are allowed to remain on an investigational drug or cross over to an investigational drug from placebo or active control following conclusion of the randomized phase of a trial. An open-label safety study is an uncontrolled trial (i.e., there is no comparison or control group). The primary purpose of both continuation and open-label safety protocols, in contrast to expanded access protocols, is to obtain safety data on the investigational drug. The conduct of continuation and open-label safety protocols differs from that of expanded access protocols in that (1) participation in open-label safety and continuation protocols is usually limited to specific, named institutions/centers;
(2) participating investigators in continuation or open-label safety protocols are already identified and trained to collect needed safety data; and (3) in the case of a continuation trial, participants are typically limited to those in the original randomized, controlled trial.
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