Three big players in the trial data world are coming together to link real-world data to new therapies and build up a better safety and efficacy profile.
Real-world data (RWD) are collected outside the confines of a typical clinical trial and tap information from patients using new drugs and vaccines out in the real world.
Knowing this can give you a much bigger and deeper base of understanding about how well and just how safe new medicines are. Now, Medidata, TriNetX, and Datavant will join forces on RWD, with each playing their own part, to mine these data more deeply.
First, the new pact will tap Medidata’s end-to-end clinical research platform to securely link their clinical data with patient consent to de-identified patient data without unblinding the study. This in turn will use Datavant’s so-called patient key technology and data ecosystem, as well as RWD from TriNetX’s global network of healthcare organizations who participate in this program.
details of which were not shared, will use RWD throughout all phases of clinical development. This includes for new therapies where trials have not yet begun, as well during trials and after they have finished.
“RWD linkage will be particularly valuable for the clinical trials conducted for COVID-19 to support the collection of additional safety and surveillance data,” the three said in statement.
“As the COVID-19 pandemic has demonstrated, the value of real-world data to speed clinical development and understand new potential therapies has never been greater,” said Travis May, CEO of Datavant, originally spun out of the Roivant family of life science companies.
“We are thrilled that our technology will support industry leaders Medidata and TriNetX to enable sponsors to connect real-world data for novel analytics while protecting patient privacy. As new vaccines and treatments come to market faster than ever before, the use of real-world data to gather additional safety and efficacy data will be critical to ensuring patient safety and continued evidence gathering.”