Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology.
Trial Design and Efficacy Thresholds for Granting Breakthrough Therapy Designation in Oncology. J Oncol Pract. 2016 Jul 26; Authors: Kern KA Abstract Breakthrough therapy designation (BTD) is a new approach created by the US Congress and the US Food and Drug Administration (FDA) as part of the FDA Innovation and Safety Act of 2012 to expedite the drug development process for serious illness, including cancer. By law, to qualify for BTD, a new molecular entity must demonstrate substantial clinical improvement over existing therapies. Although the administrative requirements for granting BTD have been made available by the FDA, the actual trial designs, end points, and quantitative therapeutic thresholds involved in the granting process have not been made public. This literature review evaluates nine oncology new molecular entities granted BTD involved in 10 accelerated approvals and summarizes the key factors in clinical trial design leading to successful BTD applications. This information can be used by oncology research teams to set goals for BTD when developing clinical trial designs and thresholds in expedited drug development programs. PMID: 27460496 [PubMed - as supplied by publisher]
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Conclusions: Due to the complexity of the behavior and biology of cells, scientists' primary focus should be on detection and elimination of sources of inflammation. Antiparasitic medications, and also antiviral, antibiotic, and antifungal medications should be thought of as underrecognized, underappreciated, and forgotten medications that can be part of cancer therapy. The information offered in this review suggests scientists should think of cancer not only as a metabolic disease but also as a metabolic parasite and should consider using antiparasitic medications under a new understanding of the role of inflammation, inf...
Conclusions: While case reports cannot be considered as proof of efficacy, these cases added to others of patients treated with the same method would suggest that this is a viable option for those patients whose disease cannot be treated successfully with other modalities. PMID: 31202206 [PubMed - in process]
Publication date: Available online 15 June 2019Source: Seminars in Cancer BiologyAuthor(s): Michael Timaner, Kelvin Tsai, Yuval ShakedAbstractMesenchymal stem cells (MSCs) are multipotent stem cells derived from the mesoderm that give rise to several mesenchymal lineages, including osteoblasts, adipocytes, chondrocytes and myocytes. Their potent ability to home to tumors coupled with their differentiation potential and immunosuppressive function positions MSCs as key regulators of tumor fate. Here we review the existing knowledge on the involvement of MSCs in multiple tumor-promoting processes, including angiogenesis, epit...
Publication date: August 2019Source: Cancer Epidemiology, Volume 61Author(s): Ryan Wendt, Yubo Gao, Benjamin J. MillerAbstractBackgroundThere is an undefined relationship between access to regional referral centers and whether the eventual oncologic outcomes are influenced by distance, travel time, or residence in a rural community.MethodsWe used the Surveillance, Epidemiology and End Results (SEER) Program Database to capture all cases of high-grade osteosarcoma from 1990 to 2014 in Iowa, Utah, and New Mexico. Using univariate, Kaplan Meier survival analysis, and multivariate Cox proportional hazards modeling we analyzed ...
ConclusionsCNS-RF is a relevant measure of prognosis in patients who have already achieved a period of remission. Providing an updated estimation of prognosis in the years following diagnosis may improve the survivors’ quality of life and access to credit or insurance.
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