The US Food and Drug Administration
(FDA) Modernization Act of 1997 provided for the creation of the
ClinicalTrials.gov system to improve transparency in clinical
research. Since its launch in 2000, the ClinicalTrials.gov system
has registered over 90,500 trials. The large volume of studies
currently listed in ClinicalTrials.gov and the high usage numbers
suggest that the system has been successful at improving access to
information about clinical studies. Current mandates, however, only
require the registration of controlled, experimental studies in
ClinicalTrials.gov. Observational studies, such as patient
registries, are not required to be listed in ClinicalTrials.gov.
Patient registries have received significant attention and funding
in recent years. Similar to controlled studies, patient registries
represent some burden to patients (e.g., time to complete patient
reported outcome measures, risk of loss of privacy), who often
participate voluntarily in hopes of improving knowledge about a
disease or condition. Patient registries also represent a
substantial investment of health research resources. Despite these
factors, patient registries are not required to be registered in
ClinicalTrials.gov, presenting the potential for duplication of
efforts and insufficient dissemination of findings that are not
published in the peer-reviewed literature. To fulfill the
obligation to patients and to ensure that resources are used in the
most efficient manner, registries need to be listed in a manner
similar to that of trials in ClinicalTrials.gov. By providing a
centralized point of collection for information about all patient
registries in the United States, the Registry of Patient Registries
(RoPR) furthers AHRQ’s goals by enhancing patient registry
information, extracted from ClinicalTrials.gov or modeled based on
the ClinicalTrials.gov data elements, to further describe the
quality, appropriateness, and effectiveness of health services (and
patient registries in particular) in a more readily available,
central location. The RoPR database system aims to achieve the
following objectives: 1) Provide a searchable database of patient
registries in the United States (to promote collaboration, reduce
redundancy, and improve transparency); 2) Facilitate the use of
common data fields and definitions in similar health conditions (to
improve opportunities for sharing, comparing, and linkage); 3)
Provide a public repository of searchable summary results
(including results from registries that have not yet been published
in the peer-reviewed literature); 4) Offer a search tool to locate
existing data that researchers can request for use in new studies;
and 5) Serve as a recruitment tool for researchers and patients
interested in participating in patient registries.
US Code:
42
USC 299 Name of Law: Healthcare Research and Quality Act of
1999
This is an ongoing collection
of information. While user participation burden remains voluntary
and minimal, with continued marketing of the RoPR as knowledge
repository for patient registries, it is anticipated that the
number of respondents will increase over time. The estimated burden
reported above reflects an increase from the burden per response
reported in the previous PRA submission. The new estimates reflect
updated system-generated counts of annual responses/updates, as of
January 2017. The new estimates also reflect an additional group of
respondents representing stewards of non-research registries. These
respondents were unlikely to use the existing ClinicalTrials.gov
pathway to RoPR. The estimated time burden for this set of
respondents reflects the time it takes an average user to complete
a registry submission using the self-registration pathway or update
an entry created through the self-registration pathway. The
self-registration process is expected to take more time than the
original registration pathway through ClinicalTrials.gov because it
involves the user entering all registry information within RoPR
(see screen shots in Attachment B displaying all data entry
fields), as opposed to entering most information in
ClinicalTrials.gov and only supplemental information in RoPR. The
process of updating these records in RoPR is also expected to take
more time than it would with other records because more fields are
involved.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 1 Review/update existing RoPR Record created through Clinical Trials.gov pathway
Attachment C - Impact Assessment_2016_January.docx
ropr supporting statement part b clean.doc
Review/update existing RoPR Record created through Clinical Trials.gov pathway