Drugs

FDA Boosting Real-World Data in Cancer Trials

Three staff members in the FDA Oncology Center of Excellence say that advances in health information technologies and a dramatic increase in the adoption of electronic health records “have created new opportunities for optimizing and streamlining clinical evidence generation through collection of real-world data.” Writing in the Journal of the National Cancer Institute, the three say that applying the principles that have shaped the theoretical foundation of biomedical research to the experimental design of real-world studies can result in an appropriate balance between the internal and external validity of clinical research, enabling more individualized treatment decisions at the point of care.

The authors, Sean Khozin, Gideon M. Blumenthal and office director Richard Pazdur say the conventional clinical trial enterprise leans heavily toward producing internally valid clinical studies, often at the expense of compromising external validity. They say this approach has resulted in uncertainties in making evidence-based individualized treatment decisions and excessive reliance on clinical judgment, which can introduce variations in practice patterns and cancer care quality. The authors add that fragmentation of clinical research to geographically dispersed sites poses a significant barrier to cancer clinical trial participation, despite growing demands for patient access to experimental therapies.

“As we carve a path toward the use of real-world evidence as a means of modernizing clinical research and evidence generation,” the article concludes, “more focus should be placed on identifying and addressing organizational barriers…. Building a scalable framework for broadening the use of real-world evidence requires organizational support driven by appropriate incentives for busy oncologists to provide clinically relevant data at the point of care and for patients to benefit from sharing their data generated on digital health platforms outside of the traditionally defined boundaries of the healthcare system.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome