Clinical Trial Results 3.5X

Clinical trials with results

The results database was launched in September 2008 to implement Section 801 of the (PDF), which requires the submission of "basic results" for certain clinical trials, generally not later than 1 year after their Completion Date (see on The submission of adverse event information was optional when the results database was released but 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 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 and a tabular summary of anticipated and unanticipated 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. staff review results submissions to ensure that they are clear and informative prior to posting to the Web site. However, cannot ensure scientific accuracy. Data providers are responsible for ensuring that submitted information is accurate and complete.

Display of Results on 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.

No Study Results Posted

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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