Literature DB >> 25359366

The Clinical Trials Transformation Initiative: innovation through collaboration.

Pamela Tenaerts1, Leanne Madre1, Patrick Archdeacon2, Robert M Califf3.   

Abstract

The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

Mesh：

Year:  2014        PMID： 25359366     DOI： 10.1038/nrd4442

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  3 in total

1.  The paradoxical problem with multiple-IRB review.

Authors:  Jerry Menikoff
Journal:  N Engl J Med       Date:  2010-10-13       Impact factor: 91.245

2.  Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2010-09-29

3.  Using central IRBs for multicenter clinical trials in the United States.

Authors:  Kathryn E Flynn; Cynthia L Hahn; Judith M Kramer; Devon K Check; Carrie B Dombeck; Soo Bang; Jane Perlmutter; Felix A Khin-Maung-Gyi; Kevin P Weinfurt
Journal:  PLoS One       Date:  2013-01-30       Impact factor: 3.240
  3 in total
  7 in total

Review 1.  Widening the path and window of opportunity for FDA approval of non-vitamin K oral anticoagulant specific antidotes and reversal agents.

Authors:  Sunny Patel; Dylan Steen
Journal:  J Thromb Thrombolysis       Date:  2016-02       Impact factor: 2.300

2.  Reflections on the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Process-Findings from a Qualitative Study.

Authors:  Timothy C Guetterman; Michael D Fetters; Laurie J Legocki; Samkeliso Mawocha; William G Barsan; Roger J Lewis; Donald A Berry; William J Meurer
Journal:  Clin Res Regul Aff       Date:  2015-09-18

Review 3.  Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

Authors:  Robert J Mentz; Adrian F Hernandez; Lisa G Berdan; Tyrus Rorick; Emily C O'Brien; Jenny C Ibarra; Lesley H Curtis; Eric D Peterson
Journal:  Circulation       Date:  2016-03-01       Impact factor: 29.690

4.  Clinical trial design and recommendations: collectively, we can take them.

Authors:  Julie Babyar
Journal:  Clin Exp Med       Date:  2017-10-13       Impact factor: 3.984

Review 5.  Overview of CDK9 as a target in cancer research.

Authors:  Fatima Morales; Antonio Giordano
Journal:  Cell Cycle       Date:  2016       Impact factor: 4.534

6.  Four Proposals to Help Improve the Medical Research Literature.

Authors:  David Moher; Douglas G Altman
Journal:  PLoS Med       Date:  2015-09-22       Impact factor: 11.069

7.  Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol.

Authors:  Ameeta Retzer; Thomas Keeley; Khaled Ahmed; Jo Armes; Julia M Brown; Lynn Calman; Chris Copland; Fabio Efficace; Anna Gavin; Adam Glaser; Diana M Greenfield; Anne Lanceley; Rachel M Taylor; Galina Velikova; Michael Brundage; Rebecca Mercieca-Bebber; Madeleine T King; Melanie Calvert; Derek Kyte
Journal:  BMJ Open       Date:  2018-02-03       Impact factor: 2.692
  7 in total

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