Literature DB >> 22556237

Research ethics. Rethinking research ethics: the case of postmarketing trials.

Alex John London1, Jonathan Kimmelman, Benjamin Carlisle.   

Abstract

Mesh：

Year:  2012        PMID： 22556237      PMCID： PMC4516406          DOI： 10.1126/science.1216086

Source DB:  PubMed          Journal:  Science        ISSN： 0036-8075            Impact factor:   47.728


× No keyword cloud information.
  17 in total

Review 1.  Ethics of undisclosed payments to doctors recruiting patients in clinical trials.

Authors:  Jammi N Rao; L J Sant Cassia
Journal:  BMJ       Date:  2002-07-06

Review 2.  Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis.

Authors:  Bruce M Psaty; Curt D Furberg; Wayne A Ray; Noel S Weiss
Journal:  JAMA       Date:  2004-11-22       Impact factor: 56.272

3.  A proposal for financing postmarketing drug safety studies by augmenting FDA user fees.

Authors:  Daniel Carpenter
Journal:  Health Aff (Millwood)       Date:  2005 Jul-Dec       Impact factor: 6.301

4.  Medicine. Moving toward transparency of clinical trials.

Authors:  Deborah A Zarin; Tony Tse
Journal:  Science       Date:  2008-03-07       Impact factor: 47.728

Review 5.  Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Authors:  Hans-Georg Eichler; Francesco Pignatti; Bruno Flamion; Hubert Leufkens; Alasdair Breckenridge
Journal:  Nat Rev Drug Discov       Date:  2008-09-12       Impact factor: 84.694

6.  Guidelines for the implementation of drug utilization observation (DUO) studies in psychopharmacological therapy. The "Phase IV Research" Task-Force of the Association for Neuropsychopharmacology and Pharmacopsychiatry (AGNP).

Authors:  M Linden; D Baier; H Beitinger; R Kohnen; M Osterheider; M Philipp; D E Reimitz; B Schaaf; H J Weber
Journal:  Pharmacopsychiatry       Date:  1997-01       Impact factor: 5.788

7.  The rise and fall of rosiglitazone.

Authors:  Steven E Nissen
Journal:  Eur Heart J       Date:  2010-02-12       Impact factor: 29.983

8.  Reputation, gatekeeping, and the politics of post-marketing drug regulation.

Authors:  Daniel Carpenter
Journal:  Virtual Mentor       Date:  2006-06-01

9.  Guidelines for phase IV clinical trials. Joint Committee on Phase IV Clinical Trial Guidelines.

Authors:  M Teehan
Journal:  Can J Psychiatry       Date:  1994-12       Impact factor: 4.356

10.  Research ethics. Beyond access vs. protection in trials of innovative therapies.

Authors:  Alex John London; Jonathan Kimmelman; Marina Elena Emborg
Journal:  Science       Date:  2010-05-14       Impact factor: 47.728
View more
  8 in total

1.  Assessing risk/benefit for trials using preclinical evidence: a proposal.

Authors:  Jonathan Kimmelman; Valerie Henderson
Journal:  J Med Ethics       Date:  2015-10-13       Impact factor: 2.903

2.  [Pain measurement in animal models].

Authors:  M Busch-Dienstfertig; C Stein
Journal:  Z Rheumatol       Date:  2013-03       Impact factor: 1.372

3.  Ethics, error, and initial trials of efficacy.

Authors:  Spencer Phillips Hey; Jonathan Kimmelman
Journal:  Sci Transl Med       Date:  2013-05-08       Impact factor: 17.956

4.  Post-marketing studies of pharmaceutical opioid abuse-deterrent formulations: a framework for research design and reporting.

Authors:  Amy Peacock; Briony Larance; Raimondo Bruno; Sallie-Anne Pearson; Nicholas A Buckley; Michael Farrell; Louisa Degenhardt
Journal:  Addiction       Date:  2018-09-07       Impact factor: 6.526

5.  Examining the Social Benefits Principle in Research with Human Participants.

Authors:  David B Resnik
Journal:  Health Care Anal       Date:  2018-03

6.  Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.

Authors:  Jean-David Zeitoun; Joseph S Ross; Ignacio Atal; Alexandre Vivot; Nicholas S Downing; Gabriel Baron; Philippe Ravaud
Journal:  BMJ Open       Date:  2017-12-21       Impact factor: 2.692

7.  Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

Authors:  Angela Spelsberg; Christof Prugger; Peter Doshi; Kerstin Ostrowski; Thomas Witte; Dieter Hüsgen; Ulrich Keil
Journal:  BMJ       Date:  2017-02-07

8.  Impact of physicians' participation in non-interventional post-marketing studies on their prescription habits: A retrospective 2-armed cohort study in Germany.

Authors:  Cora Koch; Jörn Schleeff; Franka Techen; Daniel Wollschläger; Gisela Schott; Ralf Kölbel; Klaus Lieb
Journal:  PLoS Med       Date:  2020-06-26       Impact factor: 11.069
  8 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.