Literature DB >> 20490338

The financing of drug trials by pharmaceutical companies and its consequences: part 2: a qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication.

Gisela Schott1, Henry Pachl, Ulrich Limbach, Ursula Gundert-Remy, Klaus Lieb, Wolf-Dieter Ludwig.   

Abstract

BACKGROUND: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This overview of current, systematic studies on this topic is intended to identify and characterize the particular aspects of the performance of a drug trial that can be affected by financial support from a pharmaceutical company.
METHODS: Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.
RESULTS: 57 publications were included for evaluation in Parts 1 and 2 of this article. A number of studies revealed that many trials financed by pharmaceutical companies-in some cases, as many as half of all such trials-are never published. Moreover, multiple publications of the same findings were found, and some reports were found to include selectively published data. Further studies revealed evidence of other problems including incomplete trial registration, constraints on publishing rights, withheld knowledge of adverse drug reactions, and the use of ghostwriters who were supplied by the pharmaceutical companies.
CONCLUSION: Financial support from a pharmaceutical company influences multiple aspects of the performance of drug trials and often leads to a favorable result for the corporate sponsor of the trial. Public access to trial protocols and results must be ensured. Moreover, more effort should be made to carry out drug trials independently, without the financial support of pharmaceutical companies.

Mesh:

Year:  2010        PMID: 20490338      PMCID: PMC2872821          DOI: 10.3238/arztebl.2010.0295

Source DB:  PubMed          Journal:  Dtsch Arztebl Int        ISSN: 1866-0452            Impact factor:   5.594


  52 in total

1.  The financing of drug trials by pharmaceutical companies and its consequences. Part 1: a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials.

Authors:  Gisela Schott; Henry Pachl; Ulrich Limbach; Ursula Gundert-Remy; Wolf-Dieter Ludwig; Klaus Lieb
Journal:  Dtsch Arztebl Int       Date:  2010-04-23       Impact factor: 5.594

2.  Origin and funding of the most frequently cited papers in medicine: database analysis.

Authors:  Nikolaos A Patsopoulos; John P A Ioannidis; Apostolos A Analatos
Journal:  BMJ       Date:  2006-03-17

3.  Frequency, nature, effects, and correlates of conflicts of interest in published clinical cancer research.

Authors:  Reshma Jagsi; Nathan Sheets; Aleksandra Jankovic; Amy R Motomura; Sudha Amarnath; Peter A Ubel
Journal:  Cancer       Date:  2009-06-15       Impact factor: 6.860

4.  An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

Authors:  Ola P Hole; Sigurd Nitter-Hauge; Henrik R Cederkvist; Finn O Winther
Journal:  Eur J Clin Pharmacol       Date:  2008-12-23       Impact factor: 2.953

5.  Conference abstracts of a new oncology drug do not always lead to full publication: proceed with caution.

Authors:  Michelle E Kho; Melissa C Brouwers
Journal:  J Clin Epidemiol       Date:  2009-01-04       Impact factor: 6.437

Review 6.  What constitutes evidence-based patient information? Overview of discussed criteria.

Authors:  Martina Bunge; Ingrid Mühlhauser; Anke Steckelberg
Journal:  Patient Educ Couns       Date:  2009-12-14

7.  Research Methods & Reporting. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines.

Authors:  Chris Graf; Wendy P Battisti; Dan Bridges; Victoria Bruce-Winkler; Joanne M Conaty; John M Ellison; Elizabeth A Field; James A Gurr; Mary-Ellen Marx; Mina Patel; Carol Sanes-Miller; Yvonne E Yarker
Journal:  BMJ       Date:  2009-11-27

8.  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

9.  Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.

Authors:  Joseph S Ross; David Madigan; Kevin P Hill; David S Egilman; Yongfei Wang; Harlan M Krumholz
Journal:  Arch Intern Med       Date:  2009-11-23

10.  Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

Authors:  Joseph S Ross; Gregory K Mulvey; Elizabeth M Hines; Steven E Nissen; Harlan M Krumholz
Journal:  PLoS Med       Date:  2009-09-08       Impact factor: 11.069

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  29 in total

1.  Of mugs, meals and more: the intricate relations between physicians and the medical industry.

Authors:  Stephan Sahm
Journal:  Med Health Care Philos       Date:  2013-05

2.  Correspondence (letter to the editor): Search bias.

Authors:  Anja Braschoss
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

3.  Correspondence (letter to the editor): Opinion leaders.

Authors:  Stefan Sachtleben
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

4.  Correspondence (letter to the editor): Need for advice.

Authors:  Guido Grass; Karolina Mäder
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

5.  A survey of german physicians in private practice about contacts with pharmaceutical sales representatives.

Authors:  Klaus Lieb; Simone Brandtönies
Journal:  Dtsch Arztebl Int       Date:  2010-06-04       Impact factor: 5.594

6.  Correspondence (letter to the editor): National foundation.

Authors:  Mathias Freund
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

7.  Correspondence (letter to the editor): Notorious weaknesses.

Authors:  Jürgen Maares
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

8.  Correspondence (letter to the editor): Wholesale accusations?

Authors:  Siegfried Throm
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

9.  Correspondence (letter to the editor): Trend gives cause for concern.

Authors:  Christoph Maier; Michael Zenz
Journal:  Dtsch Arztebl Int       Date:  2010-09-24       Impact factor: 5.594

10.  Relevance of pharmacoepidemiology to Nepal.

Authors:  Santosh Thapa; Subish Palaian; Hisham Aljadhey; Pathiyil Ravi Shankar
Journal:  Australas Med J       Date:  2013-08-31
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