February 2024 SOCRA Source Journal - Journal - Page 31
for an ACT must register the
clinical trial within 21 days
after enrollment of the first
participant and update the
registration at least every 12
months. Amendments must be
submitted within 15 or 30 days
of the change. Summary results
(including adverse events) must
be submitted for certain ACTs
not later than one year after the
trial’s primary completion date.
The primary completion date is
the date that the last participant
received the last intervention or
treatment. FDAAA defines the
responsible party as the sponsor
(or sponsor-investigator) who
is the IND or IDE holder. If
the study is not conducted
under an IND or an IDE, the
responsible party is the industry,
academic institution, or other
organization that initiated the
study.4 Clinical trial registration
and results submission makes
this information publicly
available. It fulfills many
purposes and benefits many
people. For studies funded
by the National Institutes
of Health (NIH), registration
and submission of results are
expected, even if the study is
not subject to 42 CFR Part 11
(i.e., even if it is not an ACT).
This applies to applications
for funding submitted on or
after January 18, 2017 for
clinical trials initiated on or
after January 18, 2017.5 The
Department of Veterans Affairs
requires principal investigators
of studies funded by the Office
of Research & Development to
register their trials and submit
summary results as a condition
of funding.6
Table 3 highlights the benefits
of clinical trial registration and
results reporting , including
fulfilling the ethical obligation
of researchers to gain the trust
of research participants and
the public. One key purpose
of registration is to reduce
publication bias. Accurate and
timely submission of results
helps the medical and research
community determine which
studies to fund.
Clinical Trials to Be Registered
on ClinicalTrials.gov
FDAAA requires registration
for all studies that meet the
definition of an ACT and either
were initiated after September
27, 2007, or initiated on or
before that date and were still
ongoing as of December 26,
2007. As discussed in more
detail in the Final Rule, and as
reflected in 42 CFR 11.10,3 ACTs
generally include interventional
studies (with one or more
arms) of FDA-regulated drug,
biological, or device products
that meet one of the following
conditions:
• The trial has one or more
sites in the United States
• The trial is conducted
under an FDA IND or IDE
application
• The trial involves a drug,
biological, or device product
that is manufactured in
the United States or its
territories and is exported
for research.
Public Law 110-85 of September
27, 2007 requires registration of
clinical trials that were opened
on or after September 27,
2007 and results submission
starting in September 2008.8
The Final Rule became effective
as of January 18, 2017.
The compliance date in the
Final Rule for implementing
the clinical trial reporting
requirements of Section 801
of FDAAA was April 18, 2017.
ClinicalTrials.gov has a checklist
for evaluating whether a clinical
trial or a study is an ACT.
FDAAA requires registration of
ACTs, defined as:
• Interventional studies
• Studies involving drugs,
biologics, or medical
devices regulated by the
FDA
• Studies that require an IND
or IDE
• Studies where one or more
of the following applies:
◦ At least one clinical
research site is in the
United States or one of
its territories, or
◦ The product is
manufactured in and
exported from the
United States or one of
its territories.
Clinical trials must be submitted
for registration on ClinicalTrials.
gov within 21 days after the
enrollment of the first patient.
The NIH, the International
Committee of Journal Editors
(ICMJE), and Medicare also
have requirements for clinical
trial registration. The NIH
Policy on Dissemination of NIHFunded Clinical Trial Information
applies to all clinical trials
funded by the NIH, regardless
of whether they are subject to
FDAAA 801 and the Final Rule
effective January 18, 2017. The
policy is effective for competing
applications and contract
proposals submitted on or after
January 18, 2017 and states
that all NIH-funded awardees
and investigators conducting
clinical trials will register and
report the results of their clinical
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