Failures in phase III: causes and consequences

B Seruga, A Ocana, E Amir, IF Tannock - Clinical Cancer Research, 2015 - AACR
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 …

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 …

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 …

A review of perspectives on the use of randomization in phase II oncology trials

MJ Grayling, M Dimairo, AP Mander… - JNCI: Journal of the …, 2019 - academic.oup.com
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 …

[HTML][HTML] Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)

MB Atkins, H Abu-Sbeih, PA Ascierto… - … for Immunotherapy of …, 2022 - ncbi.nlm.nih.gov
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 …

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 …

[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 …

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 …

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 …

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 …