Topic: clinical trial design
TrialSpark launches its first clinical trial sites as part of a partnership with Novartis that takes a new direction.
ICER is considering charging biotech companies for early scientific advice and direct guidance in clinical trial design.
Sponsors accepted into the four-year pilot will meet twice with the FDA to discuss regulatory approaches to complex trials.
The partnership focuses on cutting the time spent searching and collecting information from medical papers and ClinicalTrials.gov.
The biotech is adding 510 patients to the phase 3 aducanumab trials after seeing more “variability” than expected in a sample size re-estimation.
The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.
TriNetX's platform uses EHR data to help drug developers with clinical trial protocol design and study site and participant identification.
Corbus will enroll 415 patients in a phase 2b trial using pulmonary exacerbations as its primary endpoint.
Datavant will partner its 150 data sets with the three organizations' unique capabilities to drive clinical trial intelligence.
The red-blood-cell-encapsulated L-asparaginase improved overall survival and other outcomes in metastatic pancreatic cancer patients.