Cardinal Health Specialty Solutions is making important strides in cancer research using real-world evidence (RWE). Research developed by Cardinal Health, published today in the Journal of the American Medical Association, suggests that RWE may be able to be applied more broadly in cancer research and regulatory filings, and could lead to accelerated clinical trials in cancer research. Real-world evidence is generated during routine clinical practice and outside the context of randomized controlled trials.
“The potential to use RWE to complement and supplement traditional data from randomized controlled trials is exciting because it could significantly accelerate the speed at which clinical trials are conducted, and as a result, innovative medicines could be approved and reach patients faster,” said Bruce Feinberg, DO, Chief Medical Officer at Cardinal Health Specialty Solutions and lead author of the study.
Bruce Feinberg, DO, Chief Medical Officer at Cardinal Health Specialty Solutions and lead author of a new cancer research study published in JAMA; Ajeet Gajra, MD, Sr. Medical Director at Cardinal Health, a co-author of the study.
Although randomized controlled trials remain the standard for assessing the safety and efficacy of new cancer therapies, there is increasing recognition that this research method is costly, time consuming and does not accurately represent the general population. These factors – combined with the growth of targeted therapies and the rapidly expanding field of drug development – have researchers and policy makers like the Federal Drug Administration (FDA) exploring how real-world evidence can be used to accelerate the drug development process.
The Cardinal Health study included 956 patients who were receiving first-line treatment for thyroid cancer, breast cancer or melanoma between 2014 and 2017. The research used a novel, real-world application of the Response Evaluation Criteria in Solid Tumors (RECIST) methodology to assess how the patients’ tumors responded to the therapy.
“The study findings show that applying RECIST methodology to real-world data may allow for accurate comparisons between real-world data and RCT data in solid tumors. We believe these findings may open the door for broader use of RWE across many areas of cancer research,” said Ajeet Gajra, MD, Sr. Medical Director at Cardinal Health and one of the co-authors of the study.
Additional information about Cardinal Health’s capabilities in real-world evidence research can be found here.