publication date: Nov. 22, 2019
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Ten health care research organizations, with help from FDA and NCI, have developed a set of common definitions for real-world endpoints, including overall survival, progression-free survival, and other non-traditional endpoints.
If real-world endpoints are indeed accurate proxies for clinical trial endpoints, real-world endpoints should start to look increasingly similar to the clinical trial endpoints as more stringent criteria are applied, said Jeff Allen, president and CEO of Friends of Cancer Research.
We asked the leadership of 10 companies to share their visions of the future of data sharing, describe their portfolios in real-world evidence, and opine on what it would take to convince FDA accept real-world endpoints in regulatory decision-making in oncology.
Questions on flavored vaping products dominated the Nov. 20 Senate confirmation hearing for Stephen M. Hahn, the administration’s pick for the job of FDA Commissioner.
Stephen A. Chagares, a New Jersey general surgeon who recently set off a national debate by using a robotic surgical device to perform mastectomies, has filed a lawsuit claiming defamation and violation of federal and state antitrust laws on the part of Monmouth Medical Center.
- Ethan Basch receives ACCC Clinical Research award
- Harmar Brereton, Dana Dornsife receive NCCS Ellen Stovall Award
- Timothy Mullett named chair-elect of the American College of Surgeons Commission on Cancer
- Roswell Park receives nearly $22M in government funding
- BMS completes acquisition of Celgene
- Care in a multidisciplinary prostate cancer clinic increases discussion of treatment options, adherence to guidelines
- UCSD researchers focus on persistent opioid use, abuse and toxicity among cancer survivors
- In Opdivo + Yervoy vs. Opdivo alone in resected high-risk melanoma and PD-L1 <1% does not meet primary endpoints
- FDA takes second action under international collaboration, approving treatment option for CLL or SLL
- FDA grants Q BioMed approval to manufacture non-opioid cancer palliation drug
- FDA approves crizanlizumab-tmca for sickle cell disease
- FDA approves givosiran for acute hepatic porphyria
- European Commission approves two regimens of Keytruda for front-line metastatic, unresectable HNSCC
- European Commission grants marketing authorization for Darzalex + lenalidomide and dexamethasone in frontline MM
- Japan grants approval of Myriad Genetics’ BRACAnalysis Diagnostic System for breast cancer patients
