Abstract
Defining a clinical trial registration and results disclosure (CTR/RD) business process is challenged by a dynamic set of expectations to be met. External stakeholder groups have differing expectations of and uses for disclosed information about clinical trials. Regulations in the United States and internationally continue to evolve and emerge. A growing number of portals offering varying information about the same studies have a profound effect on the volume of work and create pressure to keep information across portals consistent. This article focuses on the challenges of changing and improving CTR/RD database processes in response to new expectations, new regulations, and imperatives for increased efficiency. Some keys for success are offered.
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Patricia Teden has disclosed that she has served as a consultant to approximately 10 biopharmaceutical companies.
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Teden, P. Clinical Trial Registration and Results Disclosure: Business Process Considerations. Ther Innov Regul Sci 44, 243–251 (2010). https://doi.org/10.1177/009286151004400306
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DOI: https://doi.org/10.1177/009286151004400306