FDAAA Basic Results Reporting: First Experience and Challenges

• Published in: Drug information journal 2011-05, Vol.45 (3), p.245-252
• Main Authors: Forst, Hans-Theo, Paarlberg, Robert, Roberts, Elizabeth
• Format: Article
• Language: English
• Subjects: Adverse events; Clinical medicine; Clinical trials; Confidence intervals; Drug Safety and Pharmacovigilance; Pharmaceutical industry; Pharmacotherapy; Pharmacy; Regulatory Affairs; Reporting requirements; State laws; Studies; Web sites; Websites
• ISSN: 2168-4790; 0092-8615; 2168-4804; 2164-9200
• DOI: 10.1177/009286151104500305

Title VIII of the Food and Drug Administration Amendments Act (FDAAA) has required basic results reporting from interventional clinical studies in a tabular format since September 27, 2008, on the US government website ClinicalTrials.gov. The State of Maine also required study results posting (including adverse event data) as of December 8, 2008. In addition to the already existing Protocol Registration System (PRS), the National Library of Medicine has developed a Results Registration System (RRS) with an entry application on the website that prepopulates table shells for results entry on the basis of the information in the PRS. Participant Flow, Baseline Characteristics, Outcome Measures, and Reported Adverse Events are the main modules of the RRS. At UCB we have entered results from more than 30 studies in RRS. This article reports our first experiences with basic results reporting from the perspective of a midsized pharmaceutical company, describes the challenges faced in establishing processes to enable results entry, and provides recommendations to improve the current RRS.