Literature DB >> 11238162

Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility.

M Lièvre1, J Ménard, E Bruckert, J Cogneau, F Delahaye, P Giral, E Leitersdorf, G Luc, L Masana, P Moulin, P Passa, D Pouchain, G Siest.   

Abstract

Keywords:  Biomedical and Behavioral Research

Mesh:

Year:  2001        PMID: 11238162      PMCID: PMC1119794          DOI: 10.1136/bmj.322.7286.603

Source DB:  PubMed          Journal:  BMJ        ISSN: 0959-8138


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  10 in total

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2.  AIDS, ethics, and clinical trials. Institute of Medical Ethics Working Party on the Ethical Implications of AIDS.

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3.  Statins and coronary heart disease.

Authors:  R Fey; N Pearson
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4.  The emerging role of statins in the prevention of coronary heart disease.

Authors:  M F Muldoon; M H Criqui
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5.  A curious stopping rule from Hoechst Marion Roussel.

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6.  Early closure of European Pimagedine trial. Steering Committee. Safety Committee.

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7.  Early stopping of trials.

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Journal:  Lancet       Date:  1997-09-20       Impact factor: 79.321

8.  Early stopping of trials.

Authors:  A Langer
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9.  Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.

Authors:  J R Downs; M Clearfield; S Weis; E Whitney; D R Shapiro; P A Beere; A Langendorfer; E A Stein; W Kruyer; A M Gotto
Journal:  JAMA       Date:  1998-05-27       Impact factor: 56.272

10.  Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group.

Authors:  J Shepherd; S M Cobbe; I Ford; C G Isles; A R Lorimer; P W MacFarlane; J H McKillop; C J Packard
Journal:  N Engl J Med       Date:  1995-11-16       Impact factor: 91.245

  10 in total
  21 in total

1.  Societal responsibilities of clinical trial sponsors. Lack of commercial pay off is not a legitimate reason for stopping a trial.

Authors:  S Evans; S Pocock
Journal:  BMJ       Date:  2001-03-10

2.  Responsibilities of sponsors are limited in premature discontinuation of trials.

Authors:  R Ashcroft
Journal:  BMJ       Date:  2001-07-07

3.  Clinical research: a European Union Directive.

Authors:  F Lemaire; An Johana Baeyens
Journal:  Intensive Care Med       Date:  2002-04-12       Impact factor: 17.440

4.  Editorial: No-difference Studies Make a Big Difference.

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Review 5.  Industry and evidence-based medicine: Believable or conflicted? A systematic review of the surgical literature.

Authors:  Chris S Bailey; Michael G Fehlings; Y Raja Rampersaud; Hamilton Hall; Eugene K Wai; Charles G Fisher
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Review 6.  Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass.

Authors:  A S Iltis
Journal:  J Med Ethics       Date:  2005-07       Impact factor: 2.903

7.  Would tirofiban have been shown non-inferior to abciximab had the TENACITY trial not been terminated for financial reasons?

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8.  Institutional ethics review of clinical study agreements.

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Journal:  J Med Ethics       Date:  2004-02       Impact factor: 2.903

9.  "One teabag is better than four": Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa.

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10.  17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial.

Authors:  C Andrew Combs; Thomas J Garite; Kimberly Maurel; Kimberly Mallory; Rodney K Edwards; George Lu; Richard Porreco; Anita Das
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