Literature DB >> 16281424

FDA introductory comments: clinical studies design and evaluation issues.

Janet Woodcock1.   

Abstract

Mesh：

Year:  2005        PMID： 16281424     DOI： 10.1191/1740774505cn096oa

Source DB:  PubMed          Journal:  Clin Trials        ISSN： 1740-7745            Impact factor:   2.486


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  9 in total

1.  Adaptive clinical trial designs in oncology.

Authors:  Yong Zang; J Jack Lee
Journal:  Chin Clin Oncol       Date:  2014-12

2.  Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.

Authors:  Luba Yammine; Charles E Green; Thomas R Kosten; Constanza de Dios; Robert Suchting; Scott D Lane; Christopher D Verrico; Joy M Schmitz
Journal:  Nicotine Tob Res       Date:  2021-08-29       Impact factor: 4.244

3.  Differences between Frequentist and Bayesian inference in routine surveillance for influenza vaccine effectiveness: a test-negative case-control study.

Authors:  Michael L Jackson; Jill Ferdinands; Mary Patricia Nowalk; Richard K Zimmerman; Burney Kieke; Manjusha Gaglani; Kempapura Murthy; Joshua G Petrie; Emily T Martin; Jessie R Chung; Brendan Flannery; Lisa A Jackson
Journal:  BMC Public Health       Date:  2021-03-16       Impact factor: 3.295

4.  Adaptive design clinical trials: Methodology, challenges and prospect.

Authors:  Rajiv Mahajan; Kapil Gupta
Journal:  Indian J Pharmacol       Date:  2010-08       Impact factor: 1.200

5.  Bayesian statistics and clinical trial designs for human cells and tissue products for regulatory approval.

Authors:  Yoji Jokura; Kazuo Yano; Natsumi Watanabe; Masayuki Yamato
Journal:  Regen Ther       Date:  2016-10-10       Impact factor: 3.419

6.  Pilot testing the effectiveness of whether a survey-driven tablet-based intervention increased willingness of Black women to attend to an initial PrEP clinic visit: The protocol for the pilot randomized controlled trial design and methods.

Authors:  Mandy J Hill; Angela M Heads; Charles Green; Robert Suchting; Angela L Stotts
Journal:  Contemp Clin Trials Commun       Date:  2022-08-27

Review 7.  Adaptive design methods in clinical trials - a review.

Authors:  Shein-Chung Chow; Mark Chang
Journal:  Orphanet J Rare Dis       Date:  2008-05-02       Impact factor: 4.123

8.  Changing the Paradigm for the Treatment and Development of New Therapies for FSGS.

Authors:  Cathie Spino; Jordan S Jahnke; David T Selewski; Susan Massengill; Jonathan Troost; Debbie S Gipson
Journal:  Front Pediatr       Date:  2016-03-23       Impact factor: 3.418

9.  Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial.

Authors:  Luba Yammine; Thomas R Kosten; Paul M Cinciripini; Charles E Green; Janet C Meininger; Jennifer A Minnix; Thomas F Newton
Journal:  Medicine (Baltimore)       Date:  2018-01       Impact factor: 1.889
  9 in total

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