About the Results Database
Contents
What Is the Results Database?
The ClinicalTrials.gov results database was launched in September 2008 to implement Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), which requires the submission of "basic results" for certain clinical trials, generally not later than one year after the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov.) Submission of adverse event information was optional when the results database was released and became required in September 2009. Results information for registered and completed studies is submitted by the study sponsor or principal investigator in a standard, tabular format without discussions or conclusions. The information is considered summary information and does not include patient-level data. The results information that is submitted includes the following:
- Participant Flow. A tabular summary of the progress of participants through each stage of a study, by study arm or comparison group. It includes the numbers of participants who started, completed, and dropped out of each period of the study, based on the sequence in which interventions were assigned.
- Baseline Characteristics. A tabular summary of the data collected at the beginning of a study for all participants, by study arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
- Outcome Measures and Statistical Analyses. A tabular summary of outcome measure values, by study arm or comparison group. It includes tables for each prespecified primary and secondary outcome and may also include other prespecified outcomes, post hoc outcomes, and any appropriate statistical analyses.
- Adverse Events. A tabular summary of all anticipated and unanticipated serious adverse events and a tabular summary of anticipated and unanticipated other adverse events exceeding a specific frequency threshold. For each serious or other adverse event, it includes the adverse event term, affected organ system, number of participants at risk, and number of participants affected, by study arm or comparison group.
ClinicalTrials.gov staff review results submissions to ensure that they are clear and informative prior to posting to the Web site. However, ClinicalTrials.gov cannot ensure scientific accuracy. Data providers are responsible for ensuring that submitted information is accurate and complete.
Display of Results on ClinicalTrials.gov
ClinicalTrials.gov organizes information for each registered study as an integrated unit, displaying the study protocol information and, if available, the corresponding results information on the same page under different tabs.
Study Results Posted
When available, study results information is included in the study record under the Study Results tab. See How to Find Results of Studies for more information on finding results entered in the results database.
No Study Results Posted
When results are not available for a study, the results tab is labeled "No Study Results Posted". Results of a study may not be posted on ClinicalTrials.gov for any of the following reasons:
- The study may not be subject to U.S. Federal requirements to submit results. See FDAAA 801 Requirements, When Do I Need to Register and Submit Results?
- The study is still ongoing.
- The study has been completed, but the deadline for results submission has not passed
- The results have been submitted but have not yet been posted (for example, pending review by ClinicalTrials.gov)
- The submission of results information has been delayed by submitting a certification or a request for extending the results submission deadline. See FDAAA 801 Requirements, Delayed Submission of Results, Certification
Learn More
For the General Public
- ClinicalTrials.gov Background: Learn about the mandate and mission of ClinicalTrials.gov, who supplies the study record data found on the Web site, and how to use the site.
For Study Sponsors and Data Providers
- Why Should I Register and Submit Results?: Learn about the purpose of study registration and results submission. Includes an overview of applicable laws and policies.
- How to Submit Your Results: Review the basic steps for submitting results, find out what information must be included, and learn about the review process.
- FDAAA 801 Requirements Learn about FDAAA 801 and the basic requirements for registering clinical studies and submitting results, including information about responsible parties, "applicable clinical trials," deadlines, and penalties.
More Information
See the Terms and Conditions for using ClinicalTrials.gov data.
