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Clinical trial

en.wikipedia.org/wiki/Clinical_trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or .... The most common clinical trials evaluate new drugs, medical devices (such as .... A randomized controll...

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/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).

A Proposal to Enhance Evaluation of New Cancer Therapies with ...

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

Mar 30, 2016 ... Skip Navigation ... Maria Koehler, Address: Pfizer Inc., 219 East 42<sup>nd</sup> Street, New York, NY, ... of real-world data to gain further insight into the impact of new drugs as they ... We propose that for oncology drugs that demonstrate “exceptional .... but the Publisher will not be held responsible for any remaining ...

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 ...

Tackling the Challenges of Developing Targeted Therapies for Cancer

www.ncbi.nlm.nih.gov/pmc/articles/PMC3227984/

Now is a time of unprecedented opportunity and progress in cancer drug ... the biological underpinnings of cancer, new drugs, directed at critical molecular targets, ... little scientific insight into the determinants of drug sensitivity and resistance; ... used with greater frequency in pivotal randomized trials of targeted therapies.

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.

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 ...

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 ...

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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New Cancer Drugs Fuel Debate over Drug Testing Process

www.pennside.com

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 ...

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 ...

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 ...