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

www.reuters.com/article/us-cancer-drugs-insight-idUSBRE98P05N20130930

Sep 30, 2013 ... Research like the Zelboraf tests, that fine-tune treatments to the genetic profile of patients, is fuelling a rethink over how new cancer drugs are ...

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

annonc.oxfordjournals.org/content/early/2016/03/29/annonc.mdw143

Mar 30, 2016 ... Skip Navigation ... Pragmatic Randomized Clinical Trials: A Proposal to Enhance ... of real-world data to gain further insight into the impact of new drugs as ... We propose that for oncology drugs that demonstrate “exceptional .... but the Publisher will not be held responsible for any remaining inaccuracies.

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

annonc.oxfordjournals.org/content/early/2016/05/09/annonc.mdw143

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).

ISSUE BRIEF - Friends of Cancer Research

www.focr.org/sites/default/files/Immunotx final 11 4.pdf

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

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 ...

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 ...

Is the Ebola Crisis a Reason to Skip RCTs? - Science-Based Medicine

www.sciencebasedmedicine.org/is-the-ebola-crisis-a-reason-to-skip-rcts/

Jan 6, 2015 ... Then a regimen adding a different investigational therapy to the new standard of care ... Trials could be designed to assess effects on survival (recovery from ... Randomized controlled trials are the most reliable way to determine whether ... Tags: Ebola, experimental drugs, RCTs, uncontrolled trials, ZMapp.

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 ...

New insights into the health effects of dietary ... - BMC Medicine

bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-10-50

New insights into the health effects of dietary saturated and omega-6 and omega- 3 ... Second, the validity of meta-analyses of clinical trials showing that CVD can be ... bias) and included others that were poorly designed (no randomization) [5, 6]. .... effects of cholesterol-lowering drugs on the clinical occurrence of cancers, ....

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 the .... Phase II randomized preoperative window-of-opportunity study of ...

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Clinical Trials: More Trials, Fewer Tribulations - Scientific American

www.scientificamerican.com

May 28, 2014 ... Skip to main content ... They assert that conventional randomized trials are too costly, delay the ... It is one of a number of oncology drugs to be approved for use by .... “We will need to test a new strategy of customization per patient and ... drug testing as an opportunity to gain insight into the disease rather ...

Clinical Cancer Advances 2016 | ASCO

www.asco.org

Skip to main content ..... Between October 2014 and October 2015, the FDA approved 10 new cancer treatments and ..... In addition, physicians gained new insight into which patients may benefit most from these drugs. ... Another randomized trial showed that nivolumab can provide a similar benefit to patients with advanced ...

Learning From the Lazarus Effect - The New York Times

www.nytimes.com

May 12, 2016 ... Most clinical trials for cancer drugs are failures. ... Skip to content Skip to navigation View mobile version .... how the drug smothered it — and, from this, gain insights that could help others ..... or because the mutation occurred at random in the genetic chaos, a passenger, while other mutations do the driving ...