Advertisement

Industry perspective on public clinical trial registries and results databases

  • Tracy Beck

Keywords

Clinical Trial Registry Clinical Trial Result Result Database Medical Journal Editor Biopharmaceutical Industry 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    United States Food and Drug Administration. Section 113 Food and Drug Administration Modernization Act of 1997. Available at: http://lhncbc.nlm.nih.gov/clin/113.html (Accessed 8 February 2006)Google Scholar
  2. 2.
    Pharmaceutical Research and Manufacturers of America. Principles on conduct of clinical trials and communication of clinical trial results. Available at: www.phrma.org/publications/policy/2002-07-18.490.pdf (Accessed 8 February 2006)Google Scholar
  3. 3.
    Pharmaceutical Research and Manufacturers of America. Updated principles for conduct of clinical trials and communication of clinical trial results. Available at: www.phrma.org/publications/quickfacts/30.06.2004.427.cfm (Accessed 8 February 2006)Google Scholar
  4. 4.
    Pharmaceutical Research and Manufacturers of America. Clinical trial registry proposal. Available at: www.phrma.org/publications/policy/06.01.2005.1111.cfm (Accessed 8 February 2006).Google Scholar
  5. 5.
    De Angelis C, Drazen JM, Frizelle FA et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Available at: www.icmje.org. (Accessed: 29 January 2006).Google Scholar
  6. 6.
    National Cancer Institute. PDQ-NCI’s comprehensive cancer database. Available at: http://www.cancer.gov/cancertopics/pdq/cancerdatabase (Accessed 8 February 2006)Google Scholar
  7. 7.
    International Federation of Pharmaceutical Manufacturers and Associations. IFPMA Improves Biomedical Data Transparency with Launch of First Worldwide Clinical Trials Portal www.ifpma.org/News/NewsReleaseDetail.aspx?nID=3471 (Accessed 8 February 2006)Google Scholar
  8. 8.
    Pharmaceutical Research and Manufacturers of America. Joint position on the disclosure of clinical trial information via clinical trial registries and databases. Available at: www.phrma.org/publications/policy//admin/2005-01-06.1113.PDF (Accessed 8 February 2006)Google Scholar
  9. 9.
    WHO Technical Council on Clinical Trial Registries Standards; www.who.int/ictrp/news/ictrp_sag_meeting_april2005_conclusions.pdf (Accessed 30 January 2006)Google Scholar
  10. 10.
    International Federation of Pharmaceutical Manufacturers and Associations. Clinical trials portal. Available at: www.ifpma.org/clinicaltrials.html (Accessed 8 February 2006)Google Scholar
  11. 11.
    De Angelis C, Drazen JM, Frizelle FA et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Available at: www.icmje.org (Accessed: 29 January 2006.)Google Scholar
  12. 12.
    Tufts Center for Drug Development. Tuft Center for the Study of Drug Development pegs cost of a new prescription medicine at $ 802 million. Available at: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=6 (Accessed 8 February 2006)Google Scholar
  13. 13.
    United States Food and Drug Administration. Challenge and opportunity on the critical path to new medical products. Available at: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html#f5 (Accessed 8 February 2006)Google Scholar
  14. 14.
    Harris Interactive, Inc. New Survey Shows Public Perception of Opportunity to Participate in Clinical Trials Has Decreased Slightly From Last Year. Available at: http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=168222 (Accessed 9 February 2006)Google Scholar
  15. 15.
    Center for Information and Study on Clinical Research Participation. Clinical trial registry survey. Available at: http://www.ciscrp.org/programs/documents/2005registrysurvey.data.forwebsite2.pdf (Accessed 8 February 2006)Google Scholar
  16. 16.
    Fair Access to Clinical Trials Act of 2004, House of Representatives, HR 5252, 108th Congress, Second Session. Available at: http://www.govtrack.us/data/us/bills.text/108/h5252.pdf (Accessed 9 February 2006)Google Scholar
  17. 17.
    Fair Access to Clinical Trials Act of 2004, US Senate, S 2933, 108th Congress, Second Session. Available at: http://www.govtrack.us/data/us/bills.text/108/s2933.pdf (Accessed 9 February 2006)Google Scholar
  18. 18.
    Pharmaceutical Research and Manufacturers of America. PhRMA Clinical Study Results Database Proposal. Available at: www.clinicalstudyresults.org/primers/Clinical_Study_Results_Database.pdf (Accessed 8 February 2006)Google Scholar
  19. 19.
    ICH Harmonised Tripartite Guideline E3, Structure and Content of Clinical Study Reports, November 1995, www.ich.org/MediaServer.jser?@_ID=479&@_MODE=GLB (Accessed 8 February 2006)Google Scholar

Copyright information

© Birkhäuser Verlag Basel/Switzerland 2006

Authors and Affiliations

  • Tracy Beck
    • 1
  1. 1.Lilly Corporate CenterEli Lilly and CompanyIndianapolisUSA

Personalised recommendations