In a recent article in Applied Clinical Trails Online, author Wayne Kubick describes the changes that could occur in conducting future clinical trials. Kubick highlights Prescription Drug User Fee Act (PDUFA V), which calls upon the FDA to establish a standardized clinical data terminology in an effort to improve pre-market analysis and safety signal detection. This regulatory improvement could provide more consistent communications between current and future clinical researchers. The requirement is projected to impact the entire clinical research community. Various open standards development organizations, such as the Clinical Data Interchange Standards Consortium (CDISC) and its joint partnerships are actively participating in the initiative, as well.
In the article, Kubick examines the current inconsistencies among current clinical studies, and then proceeds to discuss the challenges in developing standards in therapeutic studies, such as gathering a consensus among researchers for definitions of key concepts and terms in the area. He proposes an online reference database/repository for the management of the therapeutic standard documents that is fully accessible to entire research community. Kubick further highlights the multiple advantages to creating information resources for therapeutic studies, such enhanced research efficiency and quality of data. To read the full article, click here.