FDA issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials in support of applications for drugs intended to treat cancer.
FDA issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
Japan’s Ministry of Health, Labour, and Welfare has accepted for review a new drug application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone or pomalidomide plus dexamethasone as a treatment for relapsed or refractory multiple myeloma.
The American Cancer Society said that Karen E. Knudsen “announced her desire to transition” from her role as CEO of the 111-year-old charity in order to pursue “the next phase of her strategy to accelerate progress against cancer.”
A meta-analysis of 25 studies—totaling over 5,000 participants—focused on a question that has been troubling patients, physicians, and regulators: Does treatment with CAR T-cell therapy contribute to the development of secondary cancers?
Tumors are able to form without any DNA mutations, according to a recent proof-of-principle study performed in flies. Epigenetic changes alone—even temporary alterations—induced permanent cancer cell fate.
I was a practicing pediatric hematologist oncologist and researcher for 21 years. As a doctor, it was a tremendous privilege to be invited into the lives of patients and families dealing with blood cancers and be entrusted with their care. As a researcher, it was incredibly rewarding to help bring more effective blood cancer therapies to kids.
A recent article in JAMA Network Open published by myself and my research collaborators—Jill Harrison at Brown University, Sarah Yarborough at Fred Hutch, and Tammy Stokes at Maury Regional Medical Center—examined the potential for a brief communication-based intervention to help older adults with cancer who live in rural settings better manage their pain.
Thomas Schwaab was named Bank of America Endowed Medical Director of ChristianaCare’s Helen F. Graham Cancer Center & Research institute.
