Clinical benefit of randomized controlled trials (RCT) supporting US Food and Drug Administration (FDA) conversion from accelerated to full approval

Drug Administration ◽

Clinical Benefit ◽

Controlled Trials ◽

Randomized Controlled ◽

Full Approval

Magnitude of clinical benefit of randomized controlled trials supporting US Food and Drug Administration approval of drugs for solid tumours

Annals of Oncology ◽

10.1093/annonc/mdx385.001 ◽

2017 ◽

Vol 28 ◽

pp. v511

Author(s):

C. Molto Valiente ◽

E. Amir ◽

A. Ocana Fernandez ◽

A. Templeton ◽

L. del Carpio Huerta ◽

...

Keyword(s):

Drug Administration ◽

Clinical Benefit ◽

Solid Tumours ◽

Controlled Trials ◽

Randomized Controlled

Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials

Mayo Clinic Proceedings ◽

10.1016/j.mayocp.2018.07.027 ◽

2019 ◽

Vol 94 (1) ◽

pp. 74-83 ◽

Cited By ~ 4

Author(s):

Daniel Shepshelovich ◽

Ariadna Tibau ◽

Hadar Goldvaser ◽

Alberto Ocana ◽

Bostjan Seruga ◽

...

Keyword(s):

Drug Administration ◽

Controlled Trials ◽

Randomized Controlled ◽

The Us

Post-marketing modifications of drug labels for cancer drugs approved by the US Food and Drug Administration between 2006 and 2016 with and without supporting randomized controlled trials.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.e18717 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. e18717-e18717

Author(s):

Daniel Shepshelovich ◽

Ariadna Tibau ◽

Hadar Goldvaser ◽

Consolacion Molto ◽

Alberto Ocana ◽

...

Keyword(s):

Drug Administration ◽

Controlled Trials ◽

Cancer Drugs ◽

Randomized Controlled ◽

The Us ◽

Post Marketing

Design analysis indicates Potential overestimation of treatment effects in randomized controlled trials supporting Food and Drug Administration cancer drug approvals

Journal of Clinical Epidemiology ◽

10.1016/j.jclinepi.2018.06.012 ◽

2018 ◽

Vol 103 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Emily M. Lord ◽

Isabelle R. Weir ◽

Ludovic Trinquart

Keyword(s):

Drug Administration ◽

Treatment Effects ◽

Design Analysis ◽

Cancer Drug ◽

Controlled Trials ◽

Randomized Controlled ◽

Drug Approvals

Clinical benefit of adenosine as an adjunct to reperfusion in ST-elevation myocardial infarction patients: An updated meta-analysis of randomized controlled trials

International Journal of Cardiology ◽

10.1016/j.ijcard.2015.09.005 ◽

2016 ◽

Vol 202 ◽

pp. 228-237 ◽

Cited By ~ 34

Author(s):

Heerajnarain Bulluck ◽

Alex Sirker ◽

Yoon K. Loke ◽

David Garcia-Dorado ◽

Derek J. Hausenloy

Keyword(s):

Myocardial Infarction ◽

Clinical Benefit ◽

Meta Analysis ◽

St Elevation Myocardial Infarction ◽

Controlled Trials ◽

Randomized Controlled ◽

St Elevation

No clinical benefit of gender-specific total knee arthroplasty: A systematic review and meta-analysis of 6 randomized controlled trials

Acta Orthopaedica ◽

10.3109/17453674.2015.1022107 ◽

2015 ◽

Vol 86 (2) ◽

pp. 274-275 ◽

Cited By ~ 1

Author(s):

Xiaobo Xie ◽

Yuexing Zhong ◽

Lijun Lin ◽

Qi Li

Keyword(s):

Systematic Review ◽

Total Knee Arthroplasty ◽

Knee Arthroplasty ◽

Clinical Benefit ◽

Meta Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Total Knee ◽

Gender Specific

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

Annals of Oncology ◽

10.1093/annonc/mdw538 ◽

2017 ◽

Vol 28 (1) ◽

pp. 157-162 ◽

Cited By ~ 29

Author(s):

J.C. Del Paggio ◽

B. Azariah ◽

R. Sullivan ◽

W.M. Hopman ◽

F.V. James ◽

...

Keyword(s):

Clinical Benefit ◽

Controlled Trials ◽

Randomized Controlled

Albumin administration – what is the evidence of clinical benefit? A systematic review of randomized controlled trials

European Journal of Anaesthesiology ◽

10.1017/s0265021503001273 ◽

2005 ◽

Vol 20 (10) ◽

pp. 771-793 ◽

Cited By ~ 3

Author(s):

G. R. Haynes ◽

R. J. Navickis ◽

M. M. Wilkes

Keyword(s):

Systematic Review ◽

Clinical Benefit ◽

Controlled Trials ◽

Randomized Controlled ◽

Albumin Administration

Additional clinical benefit independent of study result or trial arm allocation to participants in multi-center randomized controlled trials

European Journal of Internal Medicine ◽

10.1016/j.ejim.2016.08.031 ◽

2016 ◽

Vol 36 ◽

pp. e24-e25

Author(s):

Shaul Atar

Keyword(s):

Clinical Benefit ◽

Controlled Trials ◽

Randomized Controlled ◽

Additional Clinical Benefit

Albumin administration - what is the evidence of clinical benefit? A systematic review of randomized controlled trials

European Journal of Anaesthesiology ◽

10.1097/00003643-200310000-00003 ◽

2003 ◽

Vol 20 (10) ◽

pp. 771-793 ◽

Cited By ~ 81

Author(s):

G. R. Haynes ◽

R. J. Navickis ◽

M. M. Wilkes

Keyword(s):

Systematic Review ◽

Clinical Benefit ◽

Controlled Trials ◽

Randomized Controlled ◽

Albumin Administration