Literature DB >> 23623356

Design of oncology clinical trials: a review.

Revathi Ananthakrishnan1, Sandeep Menon.   

Abstract

Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This review focuses on statistical considerations in the design and analysis of oncology clinical trials.
Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Entities:  

Keywords:  II and III oncology clinical trials; PK/PD modeling; Phases I; Safety and efficacy endpoints; Statistical analyses; Trial designs

Mesh：

Year:  2013        PMID： 23623356     DOI： 10.1016/j.critrevonc.2013.03.007

Source DB:  PubMed          Journal:  Crit Rev Oncol Hematol        ISSN： 1040-8428            Impact factor:   6.312


  8 in total

1.  A Primer on RECIST 1.1 for Oncologic Imaging in Clinical Drug Trials.

Authors:  Kathleen Ruchalski; Marta Braschi-Amirfarzan; Michael Douek; Victor Sai; Antonio Gutierrez; Rohit Dewan; Jonathan Goldin
Journal:  Radiol Imaging Cancer       Date:  2021-05

2.  Characteristics of drug combination therapy in oncology by analyzing clinical trial data on ClinicalTrials.gov.

Authors:  Menghua Wu; Marina Sirota; Atul J Butte; Bin Chen
Journal:  Pac Symp Biocomput       Date:  2015

Review 3.  Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Authors:  Miranta Antoniou; Ruwanthi Kolamunnage-Dona; Andrea L Jorgensen
Journal:  J Pers Med       Date:  2017-01-25

4.  Pragmatic medicine in solid cancer: a translational alternative to precision medicine.

Authors:  Jan Brábek; Daniel Rosel; Michael Fernandes
Journal:  Onco Targets Ther       Date:  2016-04-05       Impact factor: 4.147

Review 5.  Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Authors:  Miranta Antoniou; Andrea L Jorgensen; Ruwanthi Kolamunnage-Dona
Journal:  PLoS One       Date:  2016-02-24       Impact factor: 3.240

6.  A class of two-sample nonparametric statistics for binary and time-to-event outcomes.

Authors:  Marta Bofill Roig; Guadalupe Gómez Melis
Journal:  Stat Methods Med Res       Date:  2021-12-06       Impact factor: 3.021

7.  An analysis of common ethical justifications for compassionate use programs for experimental drugs.

Authors:  Kasper Raus
Journal:  BMC Med Ethics       Date:  2016-10-18       Impact factor: 2.652

8.  Design and Conduct Considerations for First-in-Human Trials.

Authors:  Jie Shen; Brandon Swift; Richard Mamelok; Samuel Pine; John Sinclair; Mayssa Attar
Journal:  Clin Transl Sci       Date:  2018-08-24       Impact factor: 4.689
  8 in total

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