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 AHRQâs 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