White paper: Standards and Ontology Driven Workflow Automation of Clinical Studies
Clinical trial costs have been rising to keep up with the complexities of drug development and the business need for better benefits to risk ratios. This 2014 paper, “Examination of Clinical Trial Cost and Barriers for Drug Development” written by the Assistant Secretary of Planning and Evaluation of U.S. Department of Health and Human Services (HHS) points out many of the cost drivers and barriers for drug development. At the time of writing this paper took into account various aspects including electronic health records, simplifying protocols and controlling amendments, wider use of EDC and other forms of testing including at-home or remote. A number of developments within the industry and regulatory environment now offer new opportunities to both reduce and streamline the clinical trial data and workflow process while improving the richness and value of the data being collected.