LibGuides: NURS 826 / 899B: Evidence Based Nursing: Regulatory info, clinical trials, and U.S. Government resources

Regulatory info, clinical trials, and U.S. Government resources

Student studying

Radarxlove. (2008, Oct. 1). October 1. Retrieved from https://www.flickr.com/photos/radarxlove/2907862202/. Used under the Creative Commons License.

Clinical and statistical reviews can provide information on directions for use, efficacy & effectiveness, and safety. Some of the more commonly searched resources are listed below, grouped geographically and then by scope of coverage (American, European, Canadian).

AHRQ - Agency for Healthcare Research and Quality
Site provides access to U.S. healthcare data and reports on quality, costs, outcomes, and patient safety.
NLM Drug Information Portal
Search for selected drug information from the U.S. National Library of Medicine and other key U.S. Government agencies. Search by drug name or category. See menu options at the top of the page to search for drug information for specific audiences.
U.S. Patent and Trademark Office
U.S. Patent office.
Heads of Medicines Agencies
Common website for the authorities/organizations responsible for human and veterinary medicines in Europe. Includes links to meetings, publications and reports, a national contact list and more.
European Medicines Agency (EMA)
The EMA evaluates and supervises medicine for human and veterinary use. To access documents, scroll to the "How to submit a request" section. Click the "online form" link or "guide on access to unpublished documents" for more information.
British Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA is responsible for regulating all medicines and medical devices in the UK.
Espacenet Patent Search
European Patent Office
Health Canada - Drugs and Health Products
Content includes reports and publications on drugs & health products, the environment, health care system and more.

3ie Briefs
International Initiative for Impact Evaluation- this site contains policy statements, systematic reviews and a repository of impact evaluations.

Regulatory Information - FDA

FDA resources are some of the main resources to search for grey literature, particularly for documents about unpublished clinical trials. The most commonly searched resources are Drugs@FDA and Devices@FDA. See Paynter's guide for specifics on what and how to search these sites.

U.S. Food and Drug Administration (FDA)
Resources for information on U.S. FDA approved human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation. Can be searched for medical and statistical reviews.
Drugs@FDA
Search for drug prescription and over the counter drugs approved for sale in the U.S. Content includes labels, generics, therapeutic equivalents, consumer information, and drug approval history. Search for Medical and Statistical Reviews.
Drug Approvals and Databases
Links to drug databases.
Devices@FDA
Search for approved FDA medical devices. Results include links to device summary information, manufacturer, approval date, user instructions, and other consumer information. Search for 510(k) Premarket Notification.
FDA Medical Device Databases
Links to medical device databases.
FDA MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Search for reports and safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics.
FDA Advisory Committees
Search the advisory committees meeting materials, which include Briefing Material, Slides, Agenda, Meeting Roster and Waivers for Conflicts of Interest if applicable.
FDA - Freedom of Information Request
Submit an electronic Freedom of Information Access request.

Student studying

Radarxlove. (2008, Oct. 1). October 1. Retrieved from https://www.flickr.com/photos/radarxlove/2907862202/. Used under the Creative Commons License.

Trial registries can be used to search for protocols and to identify unpublished studies and outcomes. Resources with the broadest global perspective are listed first.

WHO International Clinical Trials Registry Platform (ICTRP)
The ICTRP Search Portal groups together multiple records about ongoing and completed clinical trials. It provides a searchable database that also contains trial registration data sets (English only).
ISRCTN Registry
The ISRCTN registers all clinical research studies (proposed, ongoing or completed) and provides each one with a unique identifying number. All study records in the database are searchable and freely accessible.
Clinical Trials Registers
Links to an international listing of clinical trials registers compiled by the York Health Economics Consortium, University of York, UK.
ClinicalTrials.gov
U.S. National Institutes of Health registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. A list of which databank sources are included in the Medline database can be viewed here: http://www.nlm.nih.gov/bsd/medline_databank_source.html
Eudra CT
European Clinical Trials Database
European Union Clinical Trials Register
Search for protocol and results information on interventional clinical trials conducted in the European Union (EU) and the European Economic Area (EEA); and those conducted outside the EU / EEA that are linked to European paediatric-medicine development.
Centerwatch Clinical Trials Listing Center
Source of clinical trials and drug information for both clinical research professionals and patients. Includes white papers, trial listings seeking study volunteers, and news and analysis on the industry.
The Yale University Open Data Access (YODA) Project
Clinical trials data.

Student studying

Radarxlove. (2008, Oct. 1). October 1. Retrieved from https://www.flickr.com/photos/radarxlove/2907862202/. Used under the Creative Commons License.

Government documents contain many grey literature documents. The first three resources are the most commonly searched.

DocuTicker
DocuTicker collects abstracts from 'grey literature': PDF reports published by government agencies, think tanks, NGOs, research institutes and other public interest groups.
NIH RePORT - Research Portfolio Online Reporting Tools
Provides access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research.
National Technical Information Service (NTIS)
NTIS serves as the largest central resource for U.S. government-funded scientific, technical, engineering, and business related information.
HSRProj - Health Services Research Projects in Progress
HSRProj provides access to information about research in progress and public health projects before results are available in a published form. Can search by keyword, Investigator, or Supporting Agency.
AHRQ Research Summaries for Consumers, Clinicians, and Policymakers
Free research summaries on various health topics suggested by the public.
U.S. Global Health Programs
Link to resources about Global Health programs. Additional link on webpage for reports from various implementing agencies.
National Institute for Health and Care Excellence (NICE)
NICE provides national guidance and advice to improve health and social care in the UK. (Ok, not U.S. Government, but still useful)

National Institute of Health (NIH) Databases and Resources
Alphabetical listing of links to all NIH databases and resources. Search by subject as well.
NLM's Health Services Research and Public Health Information Programs
This site contains links to NIH public health projects and resources including collaborative projects, databases, preformulated searches, outreach & training, publications and more.
U.S. Department of Health and Human Services (HHS)
HHS is the U.S. government’s principal agency for health protection. Content includes news, grants, prevention, and regulation information. Under the HHS Secretary tab find links to a blog, speeches, op-eds and more.
CDC Community Health Status Indicators (CHSI 2015)
This is an interactive web application that produces health profiles for all 3,143 counties in the United States. This tool is useful for assessing community health status and identify disparities. Profiles cover health care access and quality, health behaviors, social factors and the physical environment.

CDC The National Institute for Occupational Safety and Health (NIOSH)
NIOSHTIC-2 is a searchable bibliographic database of occupational safety and health publications.
SafetyLit
Injury prevention literature.

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