ClinicalTrials.gov
ClinicalTrials.gov
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
ClinicalTrials.gov Videos and Presentations
- ClinicalTrials.gov: New HHS and NIH Trial Reporting Requirements
sponsored by NNLM MAR, Rebecca Williams (speaker), May 2017 (58 minutes) - Policy Updates in Trial Registration and Results Reporting
Rebecca Williams, ClinicalTrials.gov, May 2015 (22 minutes) - Using the ClinicalTrials.gov Results Database
Rebecca Williams, ClinicalTrials.gov, May 2014 (20 minutes) - ClinicalTrials.gov from Learn
Online tutorials, videos, and other instructional materials from the NLM Learning Resources Database
General Resources about Clinical Trials for Patients
- ClinicalTrials.gov: Learn About Clinical Studies
- ClinicalTrials.gov: For Patients and Families
- MedlinePlus: Clinical Trials
In English and Spanish - MedlinePlus: Understanding Medical Research
In English and Spanish - NIH Clinical Research Trials and You
- NHLBI: Children and Clinical Studies
In English and Spanish - NIH News in Health: Be a Partner in Clinical Research
- ResearchMatch.org
ClinicalTrials.gov Information for Medical Librarians
NNLM PSR offers a three-week Moodle course for medical librarians: ClinicalTrials.gov: Results Reporting, Unique Evidence, and the Role of Medical Librarians. This course has been approved for 4 hours of Medical Library Association Continuing Education units.
Course Description
ClinicalTrials.gov is the openly available federal registry and results database of publicly and privately funded clinical studies conducted in the United States and around the world. ClinicalTrials.gov is a vital resource for researchers, healthcare providers, and health sciences librarians who wish to consult the entire body of evidence on any particular topic. The 4.0 credit Moodle course is divided into three modules that contain PowerPoint lectures, reading assignments, and discussion assignments.
Objectives
Participants will be able to:
- Learn about the significance of ClinicalTrials.gov
- Search and interpret the results database
- Be informed about the number of study records with results, and
- Learn how health sciences librarians can advocate to clinical researchers the importance of complying with the results submission requirements mandated by federal law.
Resources about ClinicalTrials.gov for Researchers
- Register a Study or Submit Results
Information for investigators and study record managers who want to register a study, submit results, or update a study record - Overview of History, Policies, and Laws
Selected events, policies, and laws related to the development and expansion of ClinicalTrials.gov - Why Should I Register and Submit Results?
Legislative and publication requirements - Registering & Reporting Results with ClinicalTrials.gov (PDF)
- FDAAA 801 Requirements
Summary of clinical trial registration and results submission requirements as described in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) - ICMJE Clinical Trial Registration Policy
- Support Materials for ClinicalTrials.gov Protocol Registration System (PRS), U.S. Laws and Regulations, and International Policies
Clinical Trial Data Resources
- Downloading ClinicalTrials.gov Content for Analysis
Download ClinicalTrials.gov study record data in XML - European Union Clinical Trials Register
Clinical trial results from the European Clinical Trials Database (EudraCT) - ClinicalStudyDataRequest.com
Request access to anonymized patient level data and supporting documents from clinical studies to conduct further research. Study sponsors who have committed to use this site are Astellas, Bayer, Boehringer Ingelheim, Eisai, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB and ViiV Healthcare. - ClinicalTrialStudyTransparency.com
Request clinical study reports (CSRs) synopses, full CSRs, or participant level data from Janssen, the Pharmaceutical Companies of Johnson & Johnson.