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Posted On: 09/18/2020 9:59:35 AM
Post# of 148884
From FDA guidelines: https://www.google.com/url?sa=t&source=we...uyOkF_3Adj
It is my understanding that AMAREX will compile the data, DMC will conduct the analysis, and CYDY will be blinded, unless the trial is stopped for efficacy/futility.
4.2. Confidentiality of Interim Data and Analyses
As described in 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices),
sponsors of well-controlled studies should take appropriate measures to minimize bias.3
Knowledge of unblinded interim comparisons from a clinical trial is generally not
necessary for those conducting or sponsoring the trial; further, such knowledge can bias
the outcome of the study by inappropriately influencing its continuing conduct or the plan
of analyses. Unblinded interim data and the results of comparative interim analyses,
therefore, should generally not be accessible by anyone other than DMC members or the
statistician(s) performing these analyses and presenting them to the DMC (see id.).
Consistent with 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices),
sponsors should establish written procedures, which may be included in the DMC charter,
to ensure the minimization of bias, such as maintaining confidentiality of the interim data
(see Section 4.3.1.4). Sponsors may, of course, also address such confidentiality issues in
written agreements between the sponsor and members of the DMC as well as written
agreements between the sponsor and investigators.
Even for trials not conducted in a double-blind fashion, where investigators and patients
are aware of individual treatment assignment and outcome at their sites, the summary
evaluations of comparative unblinded treatment results across all participating centers
would usually not be available to anyone other than the DMC. Section 6 addresses the
particular confidentiality issues for the statistician/statistical team performing the interim
analyses.
4.2.1. Interim Data
Interim comparative data, whether treatment assignment is revealed or coded, will
be most securely protected from inadvertent or inappropriate access by the
sponsor or its project team if the data are prepared for analysis by a statistical
group that is independent of the sponsor and investigators—that is, the group is
not otherwise involved in the trial design or conduct and has no financial or other
important connections to the sponsor or other trial organizers (see Section 6). The lead investigators, the study steering committee, and/or the sponsor generally
develop the analytical plan (often collaboratively), but problems can arise when
these same individuals are involved in the actual preparation of the interim
results, for reasons discussed in Section 6.4. They may, however, work with the
statistician who will be preparing and presenting the interim analyses prior to the
first analysis of unblinded data to develop a template for the interim reports.
Procedures should be established to safeguard confidential interim data from the
project team, investigators, sponsor representatives, or anyone else outside the
DMC and the statistician(s) performing the interim analyses (see 21 CFR
314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices)).
Although assigning responsibility for interim analysis to individuals employed by
the sponsor is generally discouraged, such assignment may be appropriate if
sufficiently secure procedures are in place to credibly ensure that the results of
such analyses are not revealed to other sponsor employees or to anyone other than
DMC members. We recommend that a description of such procedures be included
in the DMC charter (see Section 4.3).
4.2.2. Interim Reports to the DMC
We recommend that any part of the interim report to the DMC that includes
comparative effectiveness and safety data presented by study group, whether
coded or completely unblinded, be available only to DMC members during the
course of the trial, including any follow-up period—that is, until the trial is
completed and the blind is broken for the sponsor and investigators. If interim
reports are shared with the sponsor, it may become impossible for the sponsor to
make potentially warranted changes in the trial design or analysis plan in an
unbiased manner (see Section 6.3). Even aggregate data on safety and efficacy
may be informative; these data may be needed for some trial management
functions (e.g., sample size adjustments, centralized endpoint assessment), but are
best limited to those who cannot otherwise carry out their trial management
responsibilities.
In some cases (for example, in open-label trials with special concerns about
safety), there may be a rationale for the sponsor and/or investigators to have
access to the ongoing comparative safety data to ensure continuous monitoring.
Such access should be specified and justified in the study protocol and understood
by the DMC (see 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1)
(devices)).
In many cases, the DMC receives reports in two parts: an "open" section, which
presents data only in aggregate and focuses on trial conduct issues such as accrual
and dropout rates, timeliness of data submission, eligibility rates and reasons for
ineligibility; and a "closed" section, in which the comparative outcome data are
presented. The open section of these reports is usually provided to sponsors, who
may convey any relevant information in these reports to investigators, IRBs, and ..."
Read More: https://investorshangout.com/post/view?id=589...z6YOylKdba
It is my understanding that AMAREX will compile the data, DMC will conduct the analysis, and CYDY will be blinded, unless the trial is stopped for efficacy/futility.
4.2. Confidentiality of Interim Data and Analyses
As described in 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices),
sponsors of well-controlled studies should take appropriate measures to minimize bias.3
Knowledge of unblinded interim comparisons from a clinical trial is generally not
necessary for those conducting or sponsoring the trial; further, such knowledge can bias
the outcome of the study by inappropriately influencing its continuing conduct or the plan
of analyses. Unblinded interim data and the results of comparative interim analyses,
therefore, should generally not be accessible by anyone other than DMC members or the
statistician(s) performing these analyses and presenting them to the DMC (see id.).
Consistent with 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices),
sponsors should establish written procedures, which may be included in the DMC charter,
to ensure the minimization of bias, such as maintaining confidentiality of the interim data
(see Section 4.3.1.4). Sponsors may, of course, also address such confidentiality issues in
written agreements between the sponsor and members of the DMC as well as written
agreements between the sponsor and investigators.
Even for trials not conducted in a double-blind fashion, where investigators and patients
are aware of individual treatment assignment and outcome at their sites, the summary
evaluations of comparative unblinded treatment results across all participating centers
would usually not be available to anyone other than the DMC. Section 6 addresses the
particular confidentiality issues for the statistician/statistical team performing the interim
analyses.
4.2.1. Interim Data
Interim comparative data, whether treatment assignment is revealed or coded, will
be most securely protected from inadvertent or inappropriate access by the
sponsor or its project team if the data are prepared for analysis by a statistical
group that is independent of the sponsor and investigators—that is, the group is
not otherwise involved in the trial design or conduct and has no financial or other
important connections to the sponsor or other trial organizers (see Section 6). The lead investigators, the study steering committee, and/or the sponsor generally
develop the analytical plan (often collaboratively), but problems can arise when
these same individuals are involved in the actual preparation of the interim
results, for reasons discussed in Section 6.4. They may, however, work with the
statistician who will be preparing and presenting the interim analyses prior to the
first analysis of unblinded data to develop a template for the interim reports.
Procedures should be established to safeguard confidential interim data from the
project team, investigators, sponsor representatives, or anyone else outside the
DMC and the statistician(s) performing the interim analyses (see 21 CFR
314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1) (devices)).
Although assigning responsibility for interim analysis to individuals employed by
the sponsor is generally discouraged, such assignment may be appropriate if
sufficiently secure procedures are in place to credibly ensure that the results of
such analyses are not revealed to other sponsor employees or to anyone other than
DMC members. We recommend that a description of such procedures be included
in the DMC charter (see Section 4.3).
4.2.2. Interim Reports to the DMC
We recommend that any part of the interim report to the DMC that includes
comparative effectiveness and safety data presented by study group, whether
coded or completely unblinded, be available only to DMC members during the
course of the trial, including any follow-up period—that is, until the trial is
completed and the blind is broken for the sponsor and investigators. If interim
reports are shared with the sponsor, it may become impossible for the sponsor to
make potentially warranted changes in the trial design or analysis plan in an
unbiased manner (see Section 6.3). Even aggregate data on safety and efficacy
may be informative; these data may be needed for some trial management
functions (e.g., sample size adjustments, centralized endpoint assessment), but are
best limited to those who cannot otherwise carry out their trial management
responsibilities.
In some cases (for example, in open-label trials with special concerns about
safety), there may be a rationale for the sponsor and/or investigators to have
access to the ongoing comparative safety data to ensure continuous monitoring.
Such access should be specified and justified in the study protocol and understood
by the DMC (see 21 CFR 314.126(b)(5) (drugs) and 21 CFR 860.7(f)(1)
(devices)).
In many cases, the DMC receives reports in two parts: an "open" section, which
presents data only in aggregate and focuses on trial conduct issues such as accrual
and dropout rates, timeliness of data submission, eligibility rates and reasons for
ineligibility; and a "closed" section, in which the comparative outcome data are
presented. The open section of these reports is usually provided to sponsors, who
may convey any relevant information in these reports to investigators, IRBs, and ..."
Read More: https://investorshangout.com/post/view?id=589...z6YOylKdba
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