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Insight: How new cancer drugs can skip randomized trials | Reuters

www.reuters.com/article/us-cancer-drugs-insight-idUSBRE98P05N20130926

Sep 26, 2013 ... In 2006 when doctors started testing a melanoma treatment made by Roche Holding AG on patients, they were used to facing slim odds - about ...

Pragmatic randomized clinical trials: a proposal to enhance ...

annonc.oxfordjournals.org/cgi/content/short/mdw143v2?rss=1

Mar 30, 2016 ... Skip Navigation ... The number of regulatory approvals for oncology new molecular entities has ... of our improved insight into the molecular basis of cancer. As a result, several new drugs have demonstrated exceptional clinical ... clinical benefit in confirmatory phase III randomized controlled trials (RCTs).

New Cancer Drugs Fuel Debate over Drug Testing Process

www.pennside.com/blog-pharma-biotech/bid/319588/New-Cancer-Drugs-Fuel-Debate-over-Drug-Testing-Process

Oct 17, 2013 ... This post is based on Insight: How new cancer drugs can skip randomized trials by Julie Steenhuysen and Ben Hirschler published in Reuters ...

Postmarketing Studies Lag After FDA Approvals - Medscape

www.medscape.com/viewarticle/813325

Oct 28, 2013 ... Insight: How New Cancer Drugs Can Skip Randomized Trials · U.S. ... Of the 20 new drugs approved for marketing by the US Food and Drug ...

The Value of Observational Cohort Studies for Cancer Drugs - NCBI

www.ncbi.nlm.nih.gov/pmc/articles/PMC2899798/

Skip to main content; Skip to navigation; Resources · How To · About NCBI ... Randomized controlled trials — the gold standard for clinical drug evaluation — can't ... For the new cancer therapies, observational cohort studies (OCSs) can help ..... is providing important insights into current treatment practices for thi...

Can we deconstruct cancer, one patient at a time?

www.ncbi.nlm.nih.gov/pmc/articles/PMC4221262/

Oct 23, 2012 ... Skip to main content; Skip to navigation; Resources · How To · About NCBI Accesskeys ... Keywords: cancer, personalized medicine, N-of-1, omics, longitudinal ... (NGS) has already yielded profound new insights into cancer biology. ... However, randomized trials can encounter difficulty in the face of ...

Window-of-Opportunity Trials in the Preoperative Setting: Insights ...

jco.ascopubs.org/content/early/2016/03/17/JCO.2015.66.2312.full

Mar 21, 2016 ... Skip to main page content ... Clinical trials of new drugs or drug combinations seeking to improve ... Although low-risk patients can be identified by using multigene ... Cancer Neoadjuvant Treatment in Postmenopausal Women) trial in ... randomized trials evaluating the addition of everolimus to endocrine ...

Overviews on FDA History > FDA and Clinical Drug Trials: A Short ...

www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm304485.htm

Apr 11, 2016 ... FDA and Clinical Drug Trials: A Short History: article by Suzanne White Junod, Ph.D. ... In the future, FDA could use these new tools not only to ban Banbar, but to ... products submitted for approval to treat serious diseases (i.e. cancer .... Although several kinds of randomized controlled trial methodologies ...

Stand Up to Cancer Scientific Summit 2014 - U.S. Food and Drug ...

www.fda.gov/NewsEvents/Speeches/ucm384494.htm

Jan 29, 2015 ... Skip to main page content; Skip to search; Skip to topics menu; Skip to ... This meeting – and the work that Stand Up to Cancer does every day ... Especially with new insights into genomics and the molecular pathways of cancer, we .... a demonstration of efficacy through large randomized controlled trials, ...

Insight into early-phase trials for lung cancer in the United States ...

cjcjournal.biomedcentral.com/articles/10.1186/s40880-015-0027-5

We found that the GLCI had a lower percentage of phase 1 lung cancer trials than ... of early-phase oncology trials in developing innovative cancer medicines, such ... trial [4], a global, multi-center, randomized, phase 3 trial conducted in 2004, .... a new therapy hypothesis that might be tested in future clinical trials, but the ...

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Pragmatic Randomized Clinical Trials: A Proposal to Enhance ...

annonc.oxfordjournals.org

Mar 30, 2016 ... You can change your cookie settings at any time. ... Skip Navigation ... Pragmatic Randomized Clinical Trials: A Proposal to Enhance Evaluation ... of real-world data to gain further insight into the impact of new drugs as they are ... We propose that for oncology drugs that demonstrate “exceptional activity” in .....

ISSUE BRIEF - Friends of Cancer Research

www.focr.org

Axel Hoos, Vice President of Oncology R&D, Glaxo-Smith Kline. Suzanne Topalian ..... Insight: How new cancer drugs can skip randomized trials. 2013. [ cited ...

And now for something completely different: drugs that work!—The ...

cco.amegroups.com

We can also do better by doing research on combinations of new and ..... Steenhuysen J, Hirschler B. Insight: How new cancer drugs can skip randomized trials.