Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop

Clinical Trial Design ◽

Invasive Bladder Cancer ◽

New Therapies ◽

American Urological Association ◽

Re: Jarow JP et al.: Clinical Trial Design For the Development of New Therapies for Non–muscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop (Urology 2014;83:262-265)

Urology ◽

10.1016/j.urology.2014.03.034 ◽

2014 ◽

Vol 84 (2) ◽

pp. 494-495 ◽

Cited By ~ 2

Author(s):

John Amrhein ◽

Ashish M. Kamat ◽

Alvaro Morales

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design ◽

Invasive Bladder Cancer ◽

Muscle Invasive Bladder Cancer ◽

Muscle Invasive ◽

American Urological Association

Contemporary Outcomes of Patients with Nonmuscle-Invasive Bladder Cancer Treated with Bacillus Calmette-Guérin: Implications for Clinical Trial Design. Reply.

10.1097/ju.0000000000002238 ◽

2021 ◽

Author(s):

Patrick J. Hensley ◽

Ashish M. Kamat

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Trial Design ◽

Clinical Trial Design ◽

Invasive Bladder Cancer ◽

Bacillus Calmette Guerin ◽

Contemporary Outcomes of Patients With Nonmuscle-Invasive Bladder Cancer Treated With Bacillus Calmette-Guérin: Implications for Clinical Trial Design. Letter.

10.1097/ju.0000000000002237 ◽

2021 ◽

Author(s):

Francesco Montorsi ◽

Marco Moschini ◽

Andrea Necchi ◽

Federico Deho ◽

Giorgio Gandaglia ◽

...

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Trial Design ◽

Clinical Trial Design ◽

Invasive Bladder Cancer ◽

Bacillus Calmette Guerin ◽

Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop

Nature Reviews Urology ◽

10.1038/s41585-021-00505-w ◽

2021 ◽

Author(s):

Elaine Chang ◽

Andrea B. Apolo ◽

Rick Bangs ◽

Stephanie Chisolm ◽

Vinay Duddalwar ◽

...

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Neoadjuvant Therapy ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design ◽

Muscle Invasive Bladder Cancer ◽

Advocacy Network ◽

Muscle Invasive ◽

Therapy Clinical Trial

Osteoarthritis clinical trial design and food and drug administration accelerated approval: lessons learned from the osteoporosis and liver fibrosis fields

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2018.02.024 ◽

2018 ◽

Vol 26 ◽

pp. S5-S6

Author(s):

M.A. Karsdal

Keyword(s):

Clinical Trial ◽

Liver Fibrosis ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design ◽

Lessons Learned ◽

Accelerated Approval

Summary of the 2008 National Institute of Allergy and Infectious Diseases–US Food and Drug Administration Workshop on Food Allergy Clinical Trial Design

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2009.05.027 ◽

2009 ◽

Vol 124 (4) ◽

pp. 671-678.e1 ◽

Cited By ~ 21

Author(s):

Marshall Plaut ◽

Richard T. Sawyer ◽

Matthew J. Fenton

Keyword(s):

Clinical Trial ◽

Food Allergy ◽

Infectious Diseases ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design

Contemporary Outcomes of Patients with Non-Muscle Invasive Bladder Cancer Treated with BCG Therapy: Implications for Clinical Trial Design

10.1097/ju.0000000000001633 ◽

2021 ◽

Author(s):

Justin T. Matulay ◽

Roger Li ◽

Patrick J. Hensley ◽

Nathan A. Brooks ◽

Vikram M. Narayan ◽

...

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Trial Design ◽

Clinical Trial Design ◽

Invasive Bladder Cancer ◽

Muscle Invasive Bladder Cancer ◽

Bcg Therapy ◽

Muscle Invasive

Osteoarthritis clinical trial design and food and drug administration accelerated approval: lessons learned from the osteoporosis and liver fibrosis fields

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2018.02.551 ◽

2018 ◽

Vol 26 ◽

pp. S271

Author(s):

M.A. Karsdal ◽

A.-C. Bay-Jensen ◽

A.R. Bihlet ◽

V.B. Kraus ◽

I. Byrjalsen ◽

...

Keyword(s):

Clinical Trial ◽

Liver Fibrosis ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design ◽

Lessons Learned ◽

Accelerated Approval

Sequential bacillus Calmette-Guérin/Electromotive Drug Administration of Mitomycin C as the Standard Intravesical Regimen in High Risk Nonmuscle Invasive Bladder Cancer: 2-Year Outcomes

10.1016/j.juro.2016.01.103 ◽

2016 ◽

Vol 195 (6) ◽

pp. 1697-1703 ◽

Cited By ~ 20

Author(s):

Christine Gan ◽

Suzanne Amery ◽

Kathryn Chatterton ◽

Muhammad Shamim Khan ◽

Kay Thomas ◽

...

Keyword(s):

Bladder Cancer ◽

High Risk ◽

Mitomycin C ◽

Drug Administration ◽

Invasive Bladder Cancer ◽

Bacillus Calmette Guerin ◽

Electromotive Drug Administration ◽

Papillary Recurrence of Bladder Cancer at First Evaluation after Induction Bacillus Calmette-Guérin Therapy: Implication for Clinical Trial Design

European Urology ◽

10.1016/j.eururo.2016.02.031 ◽

2016 ◽

Vol 70 (5) ◽

pp. 778-785 ◽

Cited By ~ 18

Author(s):

Chinedu O. Mmeje ◽

Charles C. Guo ◽

Jay B. Shah ◽

Neema Navai ◽

H. Barton Grossman ◽

...

Keyword(s):

Clinical Trial ◽

Bladder Cancer ◽

Trial Design ◽

Clinical Trial Design ◽

Bacillus Calmette Guerin