Failures in phase III: causes and consequences
Phase III randomized controlled trials (RCT) in oncology fail to lead to registration of new
therapies more often than RCTs in other medical disciplines. Most RCTs are sponsored by …
therapies more often than RCTs in other medical disciplines. Most RCTs are sponsored by …
Modeling and predicting clinical efficacy for drugs targeting the tumor milieu
M Singh, N Ferrara - Nature biotechnology, 2012 - nature.com
Disappointing results from most late-stage clinical trials of cancer therapeutics indicate a
need for improved and more-predictive animal tumor models. This insufficiency of models …
need for improved and more-predictive animal tumor models. This insufficiency of models …
Precision medicine needs randomized clinical trials
ED Saad, X Paoletti, T Burzykowski… - Nature reviews Clinical …, 2017 - nature.com
The advent of precision medicine has prompted profound changes in clinical cancer
research, and the rising numbers of new therapeutic agents pose challenges in terms of the …
research, and the rising numbers of new therapeutic agents pose challenges in terms of the …
A review of perspectives on the use of randomization in phase II oncology trials
Historically, phase II oncology trials assessed a treatment's efficacy by examining its tumor
response rate in a single-arm trial. Then, approximately 25 years ago, certain statistical and …
response rate in a single-arm trial. Then, approximately 25 years ago, certain statistical and …
[HTML][HTML] Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)
The broad activity of agents blocking the programmed cell death protein 1 and its ligand (the
PD-(L) 1 axis) revolutionized oncology, offering long-term benefit to patients and even …
PD-(L) 1 axis) revolutionized oncology, offering long-term benefit to patients and even …
NCI–RTOG translational program strategic guidelines for the early-stage development of radiosensitizers
YR Lawrence, B Vikram, JJ Dignam… - Journal of the …, 2013 - academic.oup.com
The addition of chemotherapeutic agents to ionizing radiation has improved survival in many
malignancies. Cure rates may be further improved by adding novel targeted agents to …
malignancies. Cure rates may be further improved by adding novel targeted agents to …
[图书][B] A Clinician's Guide to Statistics in Mental Health
SN Ghaemi - 2023 - books.google.com
The second edition of a clear and accessible guide to the application of statistics in
psychiatric practice. The book expertly describes statistical concepts in clear and simple …
psychiatric practice. The book expertly describes statistical concepts in clear and simple …
Mathematical modeling in scheduling cancer treatment with combination of VEGF inhibitor and chemotherapy drugs
X Lai, A Friedman - Journal of Theoretical Biology, 2019 - Elsevier
The present paper considers a treatment of cancer with a combination of anti-VEGF
(bevacizumab) and a chemotherapy drug (docetaxel). Since anti-VEGF reduces the …
(bevacizumab) and a chemotherapy drug (docetaxel). Since anti-VEGF reduces the …
Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: a …
V Diéras, H Wildiers, J Jassem, LY Dirix, JP Guastalla… - The Breast, 2015 - Elsevier
Introduction This phase 2 randomized study evaluated trebananib (AMG 386), a peptide-Fc
fusion protein that inhibits angiogenesis by neutralizing the interaction of angiopoietin-1 and …
fusion protein that inhibits angiogenesis by neutralizing the interaction of angiopoietin-1 and …
Considerations of sex and gender differences in preclinical and clinical trials
L Raz, VM Miller - Sex and gender differences in pharmacology, 2012 - Springer
Women continue to be underrepresented in clinical trials, particularly in Phases I and II of
experimental drug studies in spite of legislative guidelines in the USA, Canada, the …
experimental drug studies in spite of legislative guidelines in the USA, Canada, the …