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Healthcare and clinical research: a critical link through standards
Clinical Data Interchange Standards Consortium, Austin, TX
Collection of clinical trial data in community oncology centers is hampered by continued reliance on paper case report forms—still used in over 60% of all clinical trials—and a lack of industry-wide standardization in the tools and applications used to collect, transfer, and analyze the data. Adding to this problem is an inability to exchange data with electronic medical record systems or with other investigators, even within the same institution, leading to much duplication of effort and inadvertent errors in data entry, transcription, and re-entry of data already collected for other purposes. The Clinical Data Interchange Standards Consortium (CDISC) has developed worldwide research-industry standards and tools for the electronic capture, exchange, submission, and archiving of clinical trial data. This article describes the accomplishments and goals of this industry-sponsored nonprofit organization and its relationship with the US Food and Drug Administration and other regulatory and standards-development organizations. The goal of CDISC is to facilitate the collection and interchange of clinical research information among investigators, regulators, and clinicians, and to accelerate the process of drug development to improve patients’ lives.
| Commun Oncol 2007;4:553–558 | full text |  206 kb |