THOUGHT LEADERSHIP

The accurate analysis and reporting of data is necessary to the evaluation of new treatments for human diseases. Regulatory authorities must weigh the risks with the benefits of treatments in their approval decisions. Often, regulators will ask sponsors to provide information about the analyses, such as the datasets and data selection criteria used to generate the results. The Clinical Data Interchange Standards Consortium (CDISC) has described their newest initiative to standardize analysis results in the form of tables, listings, and figures (TLF) and reporting of data across the industry.