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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 ...

Is Participation in Cancer Phase I Trials Really Therapeutic?

jco.ascopubs.org/content/early/2016/09/15/JCO.2016.67.9902.full

Sep 19, 2016 ... Skip to main page content ... The new policy amplifies the earlier position, reasserting two closely ... However, intent alone does not underwrite an actual therapeutic claim. ... drug regimens that are ultimately vindicated in randomized trials. ... Because only one in 20 cancer drugs introduced into trials is ...

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.

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 ...

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...

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.

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.

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 ...

Immunotherapy Beats Chemotherapy for Advanced Bladder Cancer ...

blog.dana-farber.org/insight/2016/10/keytruda-immunotherapy-beats-chemotherapy-for-advanced-bladder-cancer-patients/

Oct 21, 2016 ... Skip to content ... Keytruda is one of a new class of immunotherapy drugs known as ... In the KEYNOTE-045 trial, the patients were randomized to receive ... Further details of the results will be presented at scientific meetings and published in journals. ... Email the editors at insight_blog@dfci.harvard.edu.

Does recent randomized prostate cancer trial provide insights on ...

www.eurekalert.org/pub_releases/2017-01/w-drr011217.php

Jan 12, 2017 ... For the first time, we now have a randomized trial comparing active monitoring, surgery, and radiation therapy for the management of localized ...