Result disclosure on ClinicalTrials. gov — first experiences and challenges

AbstractThe disclosure of clinical trial 'basic' results on the website ClinicalTrials. gov has been legally required since September 2008 for all FDA-approved trials or cleared drugs and devices. Since that time, many additions (e.g.adverse event reporting in September 2009) and corrections (both content and format related) have been implemented. As most of the information needed for ClinicalTrials. gov is created anyway during the analysis and reporting of a clinical trial, a well-defined process can be established to collect the needed results during the programming of tables and listings for the trial report. In addition, the ongoing changes in the disclosure requirements and the different responsibilities and functions involved in trial disclosure lead to many challenges in defining and establishing such a process. This paper will focus on the process definition and execution from the programmer's perspective. We will also discuss common pain points of interpreting the ClinicalTrials. gov requirements.