Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

Therapeutic Agents ◽

Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval

Milbank Quarterly ◽

10.1111/1468-0009.12261 ◽

2017 ◽

Vol 95 (2) ◽

pp. 261-290 ◽

Cited By ~ 21

Author(s):

HUSEYIN NACI ◽

OLIVIER J. WOUTERS ◽

RADHIKA GUPTA ◽

JOHN P.A. IOANNIDIS

Keyword(s):

Drug Administration ◽

Therapeutic Agents ◽

Accelerated Approval ◽

Cumulative Evidence ◽

Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.9498 ◽

2020 ◽

Vol 3 (7) ◽

pp. e209498 ◽

Cited By ~ 1

Author(s):

Andrea MacGregor ◽

Audrey D. Zhang ◽

Joshua D. Wallach ◽

Joseph S. Ross ◽

Matthew Herder

Keyword(s):

Drug Administration ◽

Therapeutic Agents ◽

The Us ◽

Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016

JAMA Internal Medicine ◽

10.1001/jamainternmed.2018.3931 ◽

2018 ◽

Vol 178 (11) ◽

pp. 1451 ◽

Cited By ~ 63

Author(s):

Thomas J. Moore ◽

Hanzhe Zhang ◽

Gerard Anderson ◽

G. Caleb Alexander

Keyword(s):

Drug Administration ◽

Therapeutic Agents ◽

The Us ◽

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

JAMA Network Open ◽

10.1001/jamanetworkopen.2021.33667 ◽

2021 ◽

Vol 4 (11) ◽

pp. e2133667

Author(s):

Joshua D. Wallach ◽

Audrey D. Zhang ◽

Joshua J. Skydel ◽

Victoria L. Bartlett ◽

Sanket S. Dhruva ◽

...

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Real World ◽

Therapeutic Agents ◽

Real World Data ◽

World Data ◽

Accelerated Approval ◽

Confirmatory Clinical Trials

Enrollment of Elderly Patients in Clinical Trials for Cancer Drug Registration: A 7-Year Experience by the US Food and Drug Administration

Yearbook of Medicine ◽

10.1016/s0084-3873(08)70434-6 ◽

2006 ◽

Vol 2006 ◽

pp. 193-194

Author(s):

P.J. Loehrer

Keyword(s):

Clinical Trials ◽

Elderly Patients ◽

Drug Administration ◽

Cancer Drug ◽

Drug Registration ◽

The Us

Poster: AML-406: Age-Based Disparities in Clinical Trials Supporting Food and Drug Administration (FDA) Approval of Therapies for Hematologic Malignancies

Clinical Lymphoma Myeloma & Leukemia ◽

10.1016/s2152-2650(21)01370-7 ◽

2021 ◽

Vol 21 ◽

pp. S217

Author(s):

Yolaine Jeune-Smith ◽

Marjorie Zettler ◽

Eli Phillips ◽

Bruce Feinberg ◽

Ajeet Gajra

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Hematologic Malignancies ◽

Fda Approval

Review of Sexual Preservation After Novel Benign Prostatic Hyperplasia Surgical Treatment Modalities From Food and Drug Administration Clinical Trials

Sexual Medicine Reviews ◽

10.1016/j.sxmr.2020.09.003 ◽

2021 ◽

Vol 9 (1) ◽

pp. 169-173

Author(s):

Naeem Bhojani ◽

Faysal A. Yafi ◽

Vincent Misrai ◽

Enrique Rijo ◽

Bilal Chughtai ◽

...

Keyword(s):

Clinical Trials ◽

Surgical Treatment ◽

Benign Prostatic Hyperplasia ◽

Drug Administration ◽

Prostatic Hyperplasia ◽

Treatment Modalities

A comparison of drug resistances of targeted drugs for advanced renal cell cancer approved by the Food and Drug Administration: A meta-analysis of randomized clinical trials

Journal of Cancer Research and Therapeutics ◽

10.4103/0973-1482.191617 ◽

2016 ◽

Vol 12 (5) ◽

pp. 109

Author(s):

Jingfeng Zhang ◽

Ming Guo ◽

Yunsong Cao ◽

Jingzhe Yang

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Renal Cell Cancer ◽

Renal Cell ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Cell Cancer ◽

Targeted Drugs ◽

Advanced Renal Cell Cancer

Academic Surgeons' Knowledge of Food and Drug Administration Regulations for Clinical Trials

Archives of Surgery ◽

10.1001/archsurg.1997.01430250096020 ◽

1997 ◽

Vol 132 (1) ◽

pp. 94 ◽

Cited By ~ 12

Author(s):

Randi L. Rutan

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Academic Surgeons

Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration

Journal of Biopharmaceutical Statistics ◽

10.1080/10543406.2010.514453 ◽

2010 ◽

Vol 20 (6) ◽

pp. 1125-1131 ◽

Cited By ~ 9

Author(s):

Werner Brannath ◽

Hans Ulrich Burger ◽

Ekkehard Glimm ◽

Nigel Stallard ◽

Marc Vandemeulebroecke ◽

...

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Adaptive Design ◽

Draft Guidance ◽

The U.S