February 2024 SOCRA Source Journal - Journal - Page 25
JOURNAL ARTICLES
ClinicalTrials.gov
Protocol Registration and
Results Reporting System
Overview
Susan Hmwe, PhD, MBBS, MS, CCRP
Susan Hmwe, PhD, MBBS, MS, CCRP
Manager, Clinical Research
Data Quality and Reporting,
NCI/CTRP and ClinicalTrials.gov PRS Administrator
National Cancer Institute (NCI) - designated
Comprehensive Cancer Center
Abstract: ClinicalTrials.gov’s protocol registration and results reporting system is the largest national
registry of clinical trials for clinical trials conducted worldwide. This article provides an overview of the
ClinicalTrials.gov protocol registration and results reporting system, including why, when, and how to
register clinical trials in the results reporting system and how to report study results. It focuses on critical
data elements where research coordinators can improve the quality of data submitted to ClinicalTrials.gov.
Disclaimer. The views and opinions stated in this article are solely the author’s own and should not be
attributed to City of Hope. The author has no relevant financial relationships with respect to this article.
OVERVIEW OF
CLINICALTRIALS.GOV
ClinicalTrials.gov is a registry
and results database of publicly
and privately supported
clinical studies involving
human participants conducted
around the world (Table 1).
It provides easy access to
information on studies in a
wide range of diseases and
conditions to patients and their
family members, healthcare
professionals, researchers, and
the public.
ClinicalTrials.gov was developed
based upon the Food and Drug
Administration Modernization
Act (FDAMA) of 1997, which
required the registration of
Investigational New Drug trials
for serious or life-threatening
diseases.1 The registry first
became available to the public
on February 29, 2000 with
1,000 studies. Since then, the
number of studies posted has
increased each year. As of July
04, 2022, 420,268 research
studies have been posted on
ClinicalTrials.gov.
The Food and Drug
Administration Amendments
Act (FDAAA), passed in 2007,
required responsible parties
to register and submit clinical
trial results on ClinicalTrials.
gov.2 The results database on
ClinicalTrials.gov was launched
in September 2008, at which
time sponsors or investigators
could begin submitting results
for their registered studies. As
of July 04, 2022, results from
54,740 registered studies had
been posted.
FDAAA AND 42 CFR PART 11
(THE FINAL RULE OF 2017)
WERE CRITICAL MILESTONES
FOR CLINICALTRIALS.GOV.
Section 801 of FDAAA required
registration of clinical studies
meeting the definition of
applicable clinical trials. The
law also requires submission
of results for certain clinical
trials. The Final Rule clarified
and explained the regulatory
requirements for submitting
registration and results
information to ClinicalTrials.
gov in compliance with Section
801 of FDAAA. It required
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