February 2024 SOCRA Source Journal - Journal - Page 33
requires preparation. Results
submission must involve the
person who knows the details of
the study design and analysis,
such as an investigator or a
statistician.
REGULATIONS RELATED
TO CLINICAL TRIAL
REGISTRATION AND RESULTS
SUBMISSION
Since April 27, 2021, the
FDA has been taking action
for failure to submit required
clinical trial results information
to ClinicalTrials.gov. Significant
changes to ClinicalTrials.gov
reporting requirements were
made based on the court case
Seife & Lurie v. U.S. Department
of Health and Human Services
et al., 2020. One of Congress’
goals when it enacted the
FDAAA in 2007 was to ensure
that clinical trial sponsors did
not cherry-pick the publicly
- available results of their
clinical trials by withholding
unfavorable results. FDAAA
801, therefore, requires that
responsible parties–clinical
trial sponsors or sponsorinvestigators– report basic
results for certain ACTs on
ClinicalTrials.gov.14
On September 21, 2016, the
Department of Health and
Human Services finalized the
Final Rule, which details the
FDAAA’s results reporting
requirements and largely mirrors
the language in the FDAAA.
In the preamble to the Final
Rule, however, the Department
of Health and Human Services
articulated an interpretation
of the basic results reporting
requirement that exempted
any ACT completed before
January 18, 2017 (the effective
date of the Final Rule), as long
as the FDA had not, prior to
study completion, granted
approval or clearance of the
investigational product. This
interpretation amounted to
a reprieve from basic results
reporting for a large number of
ACTs initiated after September
27, 2007 (or that were ongoing
as of December 26, 2007) and
completed by January 17, 2017.
The Seife court rejected the
Department of Health and
Human Services’ interpretation,
ruling that the FDAAA requires
responsible parties to report
basic results for ACTs even
if the FDA grants marketing
authorization after the trial is
completed.15 In light of the
government’s decision not to
appeal the Seife ruling, the NIH
has fully adopted this and now
requires basic results of ACTs
to be submitted as soon as
possible for all ACTs completed
before January 18, 2017, if the
ACT studies a product that is
approved, licensed, or cleared
by the FDA at any time.
An FAQ on ClinicalTrials.gov
further states that. “FDA and
NIH may take action against
responsible parties if they do
not submit required results
information for [clinical trials]
affected by the Federal Court’s
decision.” FDAAA Section
801 authorizes significant civil
monetary penalties for noncompliance, which could also
jeopardize existing or future
grant funding from the NIH
and the FDA under the Public
Health Service Act.
Responsible parties should
determine which, if any, of their
clinical trials are affected by
this change and prepare and
submit the basic results of those
trials to ClinicalTrials.gov. Basic
results include demographic
characteristics of the ACT’s
patient sample, primary and
secondary outcomes, a point
of contact for information
regarding the ACT, and
agreements that may limit
what a principal investigator
may say about an ACT after its
completion. 15 This federal
court ruling requires clinical trial
sponsors to report a decade’s
worth of previously exempted
data to the NIH for publication
on ClinicalTrials.gov.
VIOLATIONS OF THE
REQUIREMENTS
FOR CLINICAL TRIAL
REGISTRATION AND RESULTS
REPORTING
Table 5 provides an overview of
violations of the requirements
for clinical trial registration and
results reporting. Users of the
public - facing ClinicalTrials.gov
site can now use the Advanced
Search function to search for
study records with FDAAA 801
violations. If the FDA has issued
a Notice of Noncompliance
with clinical trial registration and
results reporting requirements
to the responsible party, the
National Library of Medicine will
enter the information about the
violation provided by the FDA
on ClinicalTrials.gov.
There are three categories
of information that may be
included on ClinicalTrials.
gov: Violation, correction, and
penalty. A violation is shown
when the FDA issues a Notice
of Noncompliance and posts
the notice on its designated
webpage. There are three types
of violations:
• Failure to submit required
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