And I'm a results information research
specialist at clinicaltrials.gov.
This presentation will describe
how clinicaltrials.gov advances
clinical trial transparency.
The third part in this micro
learning of the overview of the
clinical trial disclosure landscape.
During this presentation I will
cover clinicaltrials.gov aims in detail
and recent updates at clinicaltrials.gov.
In one,
At clinicaltrials.gov,
the first aim is to collect complete and
useful information about clinical studies.
How is this accomplished?
Theclinicaltrials.gov website and
database was developed in design.
to not only satisfy the legal requirements
of registration and results reporting
under FONA 801 and 42 CFR part 11,
as described in Part 2
of this micro learning,
but to promote objective standardized
reporting of this information.
The protocol registration,
and result system.
The PRS component of the
database is intended to facilitate
good reporting practices,
and then it provides structured
data entry to ensure complete
reporting and to make the review
of submissions more efficient.
The consistent display of data elements
across records also allows for the
search and comparison of public trials.
Additionally,
the database is intended to
complement publications.
In the example shown for this
trial the publication,
clearly and transparently indicates
that data for all prespecified primary
and secondary outcome measures is
reported to clinicaltrials.gov.
As mentioned,
the PRS
provides structured data entry
to ensure complete reporting and to
make the review of submissions more
efficient so that information can be
made publicly available in a timely manner.
Once an account is created
and the responsible party has
registered an completed a trial,
results information is required
to be submitted for applicable
clinical trials within one year
of the primary completion date.
Upon this submission,
the study record goes through a manual
quality control review by NLM staff.
For ACTs with a study start date
on or after January 18th, 2017,
and 1st submitting results after January 1st,
2020,
the study record is publicly posted
within 30 days of submission,
regardless of whether or not there are
major issues noted during the QC review.
Next we will go into more detail
on the QC review process.
Before submission of registration
or results information,
there are automated validation
rules in the PRS.
If there are any errors detected or if
any required information is missing,
you will be prevented from releasing
the study record for review.
Once the study record is released for review,
the manual review by NLM staff begins.
Established review criteria are
used to identify apparent errors,
deficiencies,
and inconsistencies.
Major issues noted must be addressed.
Advisory issues are optional,
but recommended to be addressed
as they're suggestions to help
improve the clarity of the record.
If there are ever questions
regarding QC comments.
Please email register@clinicaltrials.gov
and be sure to include the NCT
number or unique protocol ID.
If prior to having the NCT assigned,
and a description of the question
with any supporting information.
QC review criteria has been
developed and established for both
registration an results submissions.
The review criteria are used
to identify apparent errors,
deficiencies, and inconsistencies.
You can access the review criteria
documents from the public website.
Aim two, the second aim of clinicaltrials.gov
is to facilitate the use of
information to help the public,
and researchers find studies of interest.
The clinicaltrials.gov public website
is used to make clinical study
information available to the public and
researchers so they can find studies of
interest for research or enrollment.
To the left of the screen is an
example of how some organizations
use downloadable content from our
database to provide specific groups of
studies of interest to their own users.
Finding studies of interest.
There are options to find studies
of interest by using first search
precision features,
such as finding studies by recruitment
status and location. Of note,
we also include important resources
for research participants and
include a disclaimer to help people
learn what a clinicaltrials.golisting does and does not mean.
As part of the modernization
process at clinicaltrials.gov,
new features will be coming soon.
As mentioned previously,
some organizations use downloadable
content from our database.
They are able to do this through the
application programming interface
or the API which is a toolbox for
programmers and other technical users
to use to access all posted information
on clinicaltrials.gov study record data.
There are over 300 search fields,
several formats and interactive
training demonstrations for using the
API at your organization on this page.
Finally, I would like to end this presentation
with some recent updates to information
that is now available on the public website.
There are now additional FAQs
posted regarding a recent federal
court decision impacting submission of
results information for certain ACTs.
Benign behavioral intervention,
exemptions and newly implemented
deadlines for submitting delayed
submission of results information.
We have also updated a document detailing
responses to top questions from
responsible parties related to COVID-19.
And we have also added new study design
examples on the Training materials page.
Thank you for your attention
to this presentation.
For additional resources related
to how clinicaltrials.gov advances
clinical trial transparency,
please review the page from which
you accessed this video.