Literature DB >> 12353370

Who owns the data in clinical trial?

Jeffrey M Drazen1.   

Abstract

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication.

Keywords:  Biomedical and Behavioral Research

Mesh:

Year:  2002        PMID: 12353370     DOI: 10.1007/s11948-002-0062-x

Source DB:  PubMed          Journal:  Sci Eng Ethics        ISSN: 1353-3452            Impact factor:   3.525


  5 in total

1.  The effect of the new federal medical-privacy rule on research.

Authors:  Jennifer Kulynych; David Korn
Journal:  N Engl J Med       Date:  2002-01-17       Impact factor: 91.245

2.  Sponsorship, authorship, and accountability.

Authors:  F Davidoff; C D DeAngelis; J M Drazen; M G Nicholls; J Hoey; L Højgaard; R Horton; S Kotzin; M Nylenna; A J Overbeke; H C Sox; M B Van Der Weyden; M S Wilkes
Journal:  N Engl J Med       Date:  2001-09-13       Impact factor: 91.245

3.  Clear-cut publication rules prove elusive.

Authors:  Eliot Marshall
Journal:  Science       Date:  2002-03-01       Impact factor: 47.728

4.  A terse amendment produces broad change in data access.

Authors:  H G Miller; W H Baldwin
Journal:  Am J Public Health       Date:  2001-05       Impact factor: 9.308

5.  Current medicolegal and confidentiality issues in large, multicenter research programs.

Authors:  P A Carney; B M Geller; H Moffett; M Ganger; M Sewell; W E Barlow; N Stalnaker; S H Taplin; C Sisk; V L Ernster; H A Wilkie; B Yankaskas; S P Poplack; N Urban; M M West; R D Rosenberg; S Michael; T D Mercurio; R Ballard-Barbash
Journal:  Am J Epidemiol       Date:  2000-08-15       Impact factor: 4.897

  5 in total

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