Table 2.
Summary Objectives and Description of Requirements for the ClinicalTrials.gov Results Database.
| Objectives |
| Satisfy legal requirements |
| Promote objective, standardized reporting by capturing key trial features in the form of tabular data while minimizing potentially subjective narrative text |
| Facilitate “good reporting practices,” including accommodation of publishing12 and regulatory13 guidelines |
| Provide structured data entry to ensure complete reporting, efficient quality review, and consistent display of both required and voluntary data elements |
| Support detailed searches with the use of the database structure and other National Library of Medicine functions14 |
| Description of scientific modules (in tabular format) |
| Participant flow: Progress of research participants through each stage of a trial according to group, including the number of participants who dropped out of the clinical trial |
| Baseline characteristics: Demographic and baseline data for the entire trial population and for each group |
| Outcome measures and statistical analyses: Aggregate results data for each primary and secondary outcome measure according to group; statistical analyses as appropriate |
| Adverse events: List of all serious adverse events; list of other (not including serious) adverse events in each group that exceed a frequency threshold of 5% within any group; both lists include adverse events, whether anticipated or unanticipated, and grouped by organ system |
| Administrative information |
| Key dates and contact information |
| Description of agreements, if any, between the sponsor and the principal investigator that would restrict dissemination of results by the principal investigator |