RWE could complement Clinical Trials
This is what has emerged from a new study, published in the Journal of the American Medical Association: real-world data sources available nowadays could only replace 15% of the clinical trials that have been considered in research.
At the same time, the positive contribution to clinical trials has been underlined, considering how RWE could examine concordance between randomized and observational studies. Moreover, RWE could confront the generalizability of a trial population with the real-world population.
A total of 220 trials have been included by researchers from the Mayo Clinic, Yale University, University of California San Francisco and Columbia University: observational data could have substituted only 33 of them, considering the impossibilities ascertainment of primary endpoints, exclusion and inclusion criteria, indication and intervention from real-world data sources.
“I think there are lots of ways that RWE will be used for medical product evaluation, but for this data to be a suitable replacement, work is still needed to enhance available data” Dr. Joseph Ross, Yale professor of medicine stated in an email.