(Q34089761)

30 July 2017

title

Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. (English)

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30 July 2017

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4

Harlan M Krumholz

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30 July 2017

Joseph S Ross

5

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Nicholas L Downes

series ordinal

1

object named as

Nicholas S Downing

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30 July 2017

2

Jenerius A Aminawung

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30 July 2017

Nilay D Shah

3

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30 July 2017

language of work or name

English

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publication date

1 January 2014

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The Journal of the American Medical Association

30 July 2017

published in

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30 July 2017

volume

311

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30 July 2017

issue

4

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30 July 2017

page(s)

368-377

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Communicating uncertainties about prescription drugs to the public: a national randomized trial

30 July 2017

cites work

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https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Availability of comparative efficacy data at the time of drug approval in the United States

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Surrogate end points in clinical trials: are we being misled?

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Regulatory review of novel therapeutics--comparison of three regulatory agencies

28 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Shattuck lecture. Innovation, regulation, and the FDA.

28 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey

28 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Randomized, controlled trials, observational studies, and the hierarchy of research designs

28 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

Equipoise and the Dilemma of Randomized Clinical Trials

28 October 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4144867

A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report

28 October 2018

1 reference

12 December 2020

FDA and pharma seek better ways to assess drug safety, efficacy in clinical trials

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12 December 2020

Newly approved does not always mean new and improved

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12 December 2020

The attitudes of oncology physicians and nurses toward phase I, II, and III cancer clinical trials

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12 December 2020

Identifiers

DOI

10.1001/JAMA.2013.282034

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30 July 2017

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30 July 2017

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