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 ...
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 ...
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 ...
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.
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.
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 ...
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 ...
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
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 ...
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