Parexel, Datavant partner on using real-world data in clinical trials
Parexel, one of the largest CROs in the world, said the partnership would involve connecting real-world data across the clinical trials it conducts.
Parexel, one of the largest CROs in the world, said the partnership would involve connecting real-world data across the clinical trials it conducts.
Aetion President Jeremy Rassen said in an interview on the sidelines of the CB Insights Future of Health conference that rare diseases and Phase IV safety studies would be examples of situations better suited to real-world evidence.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The New York-based drugmaker marks the third major biopharma company to partner with the San Francisco-based firm, after Amgen and Roche.
The German drugmaker plans to submit its data package for FDA approval by the end of the year, with potential approval next year. The package will include a synthetic control arm comprising real-world data.
Software company Aetion said Wednesday that the regulatory agency and hospital would expand the real-world evidence partnership they announced last year.
The partnership will focus on using real-world evidence to improve understanding of responses among patients with acute myeloid leukemia whose disease carries mutations in the FLT3 gene. Astellas markets a drug for FLT3-positive AML, Xospata, approved in November.
The companies will partner to use real-world data and artificial intelligence in clinical trial design and the creation of synthetic control arms.