Masterarbeit

Changes to clinical reporting requirements within the scope of title VII of the FDA Amendment ACT (FDAAA): An Industry Perspective

Frank Michaelsen (2010)

Language: English

In recent years publication bias and selective reporting by entities wishing to present a favorable image has led to well recognized problems in biomedical literature. Thereby, positive findings were more likely to be reported than negative or inconclusive ones. As a result of this development transparency in clinical trial information has become increasingly important to healthcare professionals, policy makers, patients and to the general public. In order to increase the level of transparency the US Food and Drug Administration Amendment Act (FDAAA) (US Public Law 110-85) which came into effect on the 27 September 2007 significantly changed the requirements for clinical trial registration in the US. Section 801 of the Act now requires drug and device companies to register their investigational studies in the NIH operated clinical trial database Clinicaltrials.gov. In addition, the law requires the reporting of clinical trial results, which poses a particular challenge for sponsors or service data providers due to the often high amount and complexity of results depending on size the and design of the respective clinical study. Specifically the extraction of results information from clinical source documentation and the subsequent transformation of this information in order to comply with the dataset requirements of Clinicaltrials.gov proved to be complicated as well as time-consuming. Moreover registration and results reporting on the international level currently remains largely unregulated. The present work examines how the FDAAA affects the ways in which clinical trials need to be reported. This is done by analyzing the key aspects behind the law in the context of the currently incomplete international regulatory framework, furthermore defining recommendations on processes, timing, and best practices to help the sponsor finding its way through the registration and reporting procedure.

Pages: 71, Annexes: pages : 0