KMR Group recently concluded an analysis spanning ten years, from 2005 to 2015, that evaluated cycle time performance for more than 17,000 interventional trials. The analysis investigates clinical trial differences by molecule type and shows an increase in both length of time and cost in large molecule clinical trials.
Several factors were analyzed: outsourcing, disease complexity, study size, and subject type. KMR Group found that large molecule trials are regularly longer at a statistically significant level and this is true across trial phases. For example, Phase III oncology trials for small molecules were found to have a median duration of 4.5 years versus 6.1 years for large molecules. Study startup, enrollment, and data capture are contributing factors to the extended trial time according to the report.
Upon reflection of the analysis, Linda Martin, President and Founder of KMR Group, stressed the importance of operational efficiency to Outsourcing-pharma.com, stating that “there may be some outstanding new biologic therapies on the horizon, but for the companies developing these drugs, identifying areas for operational improvement has never been more critical.”
Need assistance with your biologic clinical research study? Contact us to explore how we can help with study design, medical writing, IRB reviews, and clinical operations staff