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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 ... 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 ...

Clinical Cancer Advances 2016 | ASCO

www.asco.org/research-progress/reports-studies/clinical-cancer-advances

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 ...

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.

ISSUE BRIEF - Friends of Cancer Research

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

Renzo Canetta, Vice President, Oncology Global Clinical Research, Bristol- Myers Squibb ..... Insight: How new cancer drugs can skip randomized trials. 2013.

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 ...

Reports > Targeted Drug Development: Why Are Many Diseases ...

www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm454955.htm

Jul 16, 2015 ... In addition, these tools can help target drugs to specific patient ... research on cancer and HIV/AIDS that has given us critical insights into the ... And it remains necessary to test new diabetes drugs in a broader ... As a result, we lack drug targets and biomarkers that can be used to help make clinical trials ...

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

cco.amegroups.com/article/view/3862/4831

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.

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 ...

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.

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

annonc.oxfordjournals.org

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).

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 ...

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

jco.ascopubs.org

Mar 21, 2016 ... Skip to main page content ... 2016 by American Society of Clinical Oncology ... Clinical trials of new drugs or drug combinations seeking to improve upon ... Although low-risk patients can be identified by using multigene assays, the ... two randomized trials evaluating the addition of everolimus to endocrine ...