Literature DB >> 25539444

The proposed rule for U.S. clinical trial registration and results submission.

Deborah A Zarin1, Tony Tse, Jerry Sheehan.   

Abstract

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Year:  2014        PMID： 25539444      PMCID： PMC4344313          DOI： 10.1056/NEJMsr1414226

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  11 in total

1.  Better access to information about clinical trials.

Authors:  A T McCray
Journal:  Ann Intern Med       Date:  2000-10-17       Impact factor: 25.391

2.  Clinical trial registration--looking back and moving ahead.

Authors:  Christine Laine; Richard Horton; Catherine D DeAngelis; Jeffrey M Drazen; Frank A Frizelle; Fiona Godlee; Charlotte Haug; Paul C Hébert; Sheldon Kotzin; Ana Marusic; Peush Sahni; Torben V Schroeder; Harold C Sox; Martin B Van der Weyden; Freek W A Verheugt
Journal:  N Engl J Med       Date:  2007-06-04       Impact factor: 91.245

3.  Evaluation of the value of attribution in the interpretation of adverse event data: a North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation.

Authors:  Shauna L Hillman; Sumithra J Mandrekar; Brian Bot; Ronald P DeMatteo; Edith A Perez; Karla V Ballman; Heidi Nelson; Jan C Buckner; Daniel J Sargent
Journal:  J Clin Oncol       Date:  2010-05-17       Impact factor: 44.544

4.  Outcome reporting in industry-sponsored trials of gabapentin for off-label use.

Authors:  S Swaroop Vedula; Lisa Bero; Roberta W Scherer; Kay Dickersin
Journal:  N Engl J Med       Date:  2009-11-12       Impact factor: 91.245

5.  Publication bias: the case for an international registry of clinical trials.

Authors:  R J Simes
Journal:  J Clin Oncol       Date:  1986-10       Impact factor: 44.544

6.  The ClinicalTrials.gov results database--update and key issues.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Robert M Califf; Nicholas C Ide
Journal:  N Engl J Med       Date:  2011-03-03       Impact factor: 91.245

7.  Selective publication of antidepressant trials and its influence on apparent efficacy.

Authors:  Erick H Turner; Annette M Matthews; Eftihia Linardatos; Robert A Tell; Robert Rosenthal
Journal:  N Engl J Med       Date:  2008-01-17       Impact factor: 91.245

8.  Underreporting research is scientific misconduct.

Authors:  I Chalmers
Journal:  JAMA       Date:  1990-03-09       Impact factor: 56.272

Review 9.  Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.

Authors:  Tom Jefferson; Mark Jones; Peter Doshi; Elizabeth A Spencer; Igho Onakpoya; Carl J Heneghan
Journal:  BMJ       Date:  2014-04-09

10.  Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

Authors:  Amy Earley; Joseph Lau; Katrin Uhlig
Journal:  BMJ Open       Date:  2013-01-18       Impact factor: 2.692
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  35 in total

Review 1.  From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

Authors:  Kanwal Pratap Singh Raghav; Sminil Mahajan; James C Yao; Brian P Hobbs; Donald A Berry; Rebecca D Pentz; Alda Tam; Waun K Hong; Lee M Ellis; James Abbruzzese; Michael J Overman
Journal:  J Clin Oncol       Date:  2015-08-24       Impact factor: 44.544

Review 2.  The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

Authors:  Claudia Pansieri; Chiara Pandolfini; Maurizio Bonati
Journal:  Eur J Clin Pharmacol       Date:  2015-08-05       Impact factor: 2.953

3.  Eyes on new product development.

Authors:  Gary D Novack
Journal:  J Ocul Pharmacol Ther       Date:  2015-03       Impact factor: 2.671

4.  Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions.

Authors:  Marleine Azar; Kira E Riehm; Nazanin Saadat; Tatiana Sanchez; Matthew Chiovitti; Lin Qi; Danielle B Rice; Brooke Levis; Claire Fedoruk; Alexander W Levis; Lorie A Kloda; Jonathan Kimmelman; Andrea Benedetti; Brett D Thombs
Journal:  JAMA Intern Med       Date:  2019-05-01       Impact factor: 21.873

Review 5.  Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

Authors:  Aaron S Kesselheim; Jennifer M Polinski; Lisa A Fulchino; Danielle L Isaman; Joshua J Gagne
Journal:  Drugs       Date:  2015-04       Impact factor: 9.546

6.  The Mass Production of Redundant, Misleading, and Conflicted Systematic Reviews and Meta-analyses.

Authors:  John P A Ioannidis
Journal:  Milbank Q       Date:  2016-09       Impact factor: 4.911

7.  Trial Reporting in ClinicalTrials.gov - The Final Rule.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Sarah Carr
Journal:  N Engl J Med       Date:  2016-09-16       Impact factor: 91.245

Review 8.  Pharmaceutical Benefit-Risk Communication Tools: A Review of the Literature.

Authors:  Dominic Way; Hortense Blazsin; Ragnar Löfstedt; Frederic Bouder
Journal:  Drug Saf       Date:  2017-01       Impact factor: 5.606

9.  Synchronous Chemoradiation Nanovesicles by X-Ray Triggered Cascade of Drug Release.

Authors:  Zijian Zhou; Alexander Chan; Zhantong Wang; Xiaolin Huang; Guocan Yu; Orit Jacobson; Sheng Wang; Yijing Liu; Lingling Shan; Yunlu Dai; Zheyu Shen; Lisen Lin; Wei Chen; Xiaoyuan Chen
Journal:  Angew Chem Int Ed Engl       Date:  2018-06-14       Impact factor: 15.336

Review 10.  Guidelines for the Reporting of Treatment Trials for Alcohol Use Disorders.

Authors:  Katie Witkiewitz; John W Finney; Alex H S Harris; Daniel R Kivlahan; Henry R Kranzler
Journal:  Alcohol Clin Exp Res       Date:  2015-08-11       Impact factor: 3.455
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