ClinicalTrials.gov: A service of the U.S. National Institutes of Health

This project has been funded in whole or in part with Federal funds from the National Library of Medicine, National Institutes of Health, Department of Health and Human Services, under Contract No. HHS-N-276-2011-00003-C with the University of Pittsburgh, Health Sciences Library System.

ClinicalTrials.gov Homepage

ClinicalTrials.gov145,377 studiesIn all 50 states and in 185 countriesData as of May 16, 2013

Why Register Clinical Trials?

• Support ethical and scientific objectives of clinical research

• Required by journal editors for trial results to be eligible for publication

• Required by U.S. Law for most clinical trials of drugs and devices

Summary Protocol Information

Results

The study results will be displayed in a tabular format that includes the following information:• Participant flow• Baseline characteristics• Outcome measures and statistical analyses• Adverse events• Administrative information

Study Records Link to Publications(when available)

Clinical Trial Process

Adapted from Figure 15-1; Principles and Practice of Clinical Research. Elsevier Inc.; 2012.

25 -50% of trials remain unpublished several years after completion

Find results faster in ClinicalTrials.gov

Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross-sectional analysis. BMJ. 2012;344:d7292.

Learning About the Law

Which trials must submit results?

• Clinical trials of FDA-approved drugs, biologics, and devices

• At least one site in the United States

• Initiated after Sept 2007 or ongoing as of Dec 2007

• (Excludes Phase I drug and small feasibility device studies)

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)For more information: http://www.clinicaltrials.gov/

Learn about Submitting Studies

Penalties for not submitting results

1. Notices of noncompliance

2. Civil monetary penalties (up to $10,000/day)

3. Withholding of NIH grant funds

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)For more information: http://www.clinicaltrials.gov/

Growth of Studies with Posted Results

Data as of May 31, 2013

Sample Uses of ClinicalTrials.gov

• Access information about specific trialoFind trials for potential participantsoTrack progress and protocol changesoSee results (if available)

• Assess available evidence relevant to a specific clinical topic

• Assess nature of current and past research

• Review methodologies used in clinical trials