April 14th 2025
An increase in protocol complexity is paving the way for machine learning models to optimize trial design.
Artificial Intelligence Drives Industry Response to Project Optimus
February 27th 2024The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.
From Words to Action: Advancing Efforts to Reduce the Racial Gap in Clinical Research
February 7th 2024Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research, White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.
Phase III Trial to Evaluate Novel Individualized Neoantigen Therapy Plus Keytruda in Lung Cancer
December 11th 2023V940 (mRNA-4157) to be evaluated in combination with Keytruda (pembrolizumab) as an adjuvant treatment for patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer.
Ten Considerations for Sensor Selection in Clinical Trials
November 9th 2023The careful selection of sensor technology prioritized in clinical trials, considering regulatory compliance, data security, device characteristics, and the specific needs of the trials for successful and confident implementation.