VIII. clinical trial transparency references

  1. Overview
  2. Defining Clinical Trial Transparency
  3. Clinical Trial Spin and Suppression
  4. Benefits and Costs of Transparency
  5. Legislative Strategies to Encourage Transparency
  6. Bottom-Up Strategies for Clinical Trial Transparency
  7. Conclusions: Towards Greater Transparency
  8. Clinical Trial Transparency References

[1]      “Clinical Research and the HIPAA Privacy Rule” National Institute of Health, US Department of Health and Human Services.  http://privacyruleandresearch.nih.gov/clin_research.asp

[2]      “Concept Paper: Quality in FDA-Regulated Clinical Research” http://www.fda.gov/oc/initiatives/criticalpath/clinicalresearch.html

[3]      “Reporting on the findings of Clinical Trials: A Discussion Paper“ Buletin of the World Health Organization Vol 86 No 6 (June 2008) http://www.who.int/bulletin/volumes/86/6/08-053769/en/index.html

[4]      Zarins, Deborah.  “Update on Clinical Trials Registration and Results Reporting Requirements; and Methodologic Issues and Next Steps in the Implementation of the Results Database”  Seminar.  February 24, 2009, Center for Health Policy, Stanford University.

[5]      Lenzer, J.  “Drug Secrets: What the FDA isn’t telling” Slate.com http://www.slate.com/id/2126918/

[6]      Office for Human Research Protections.  United States Department of Health and Human Services [http://www.hhs.gov/ohrp/]

[7]      Public Meeting on U.S. Public Law 110-85.  National Institutes of Health.  Bethesda, MD.  April 20th 2009. [http://prsinfo.clinicaltrials.gov/public-meeting-april09.html]

[8]      McGoey L, Jackson E.  “Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity”  J. Med Ethics 2009 35:109-112

[9]      Young D.  “New Clinical Trial Mandate Poses Concerns for Drug Firms”  March 24, 2008.  Bioworld Today.

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=47152

[10]    PRS and U.S. Public Law 110-8 ClinicalTrials.gov http://prsinfo.clinicaltrials.gov/fdaaa.html

[11]      http://scientific-misconduct.blogspot.com/search/label/Procter%20and%20Gamble

[12]    PHrmA.  “Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results” April 2009

[13]    Bains, William.  “Fraud and Scandal in Biotech”  Nature Biotechnology 24, 745 – 747

[14]    Lurie P. and Pitts P.  “A Dialogue on Whether Disclosure Will Quiet The Industry’s Critics?” Oral Presentation. http://www.icvclients.com/ehcca/disclosure2009/1_500/

[15]    Guo S-W, Hummelshoj L, Olive D, Bulun S, D’Hooghe TM, Evers JLH.  “A call for more transparency of registered clinical trials on endometriosis”  Human Reproduction 10.1093/humrep/dep045

[16]    Korn D., Ehringhaus S.  “Principles for Strengthening the Integrity of Clinical Research” PLoS Clinical Trials (2006)

[17]    H.R. 5605 “Physician Payments Sunshine Act of 2008.” [never became law]  http://www.govtrack.us/congress/bill.xpd?bill=h110-5605

[18]    H.R. 3580 / US Public Law110-85 121 STAT. 823 Sept 27 2007 “FDA Amendments Act of 2007″ http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf

[19]    McDonald D and Zisson S.  “Biopharmaceutical companies tackle clinical trial transparency”  in Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products.  Thomson Inc.  Boston, MA. (2006)  pp

[20]    Foote, MaryAnn. “Clinical Trial Registries and Publication of Results: A Primer” in Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products.  Thomson Inc.  Boston, MA. (2006)

[21]    Dwan, K et. al.  “Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias”  PLoS ONE. August 2008 Vol 3 No 8. e3081.

[22]    “GAP Client Exposes Flawed Procedure in Procter & Gamble Drug Study” Press Release.  Feb 22 2006.  Government Accountability Project, Washington DC. http://www.whistleblower.org/content/press_detail.cfm?press_id=371

[23]    Fleishacker, Sheila and Cohen, Mark.  “The ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment.  A Roadmap For Conducting Credible Trials and Protecting Drug Trial Participants”  Government Accountability Project, Washington, DC.  April 2009.

[24]    Washburn, Jennifer.  “Rent-a-Researcher: Did a British university sell out to Procter & Gamble?” Slate. 22 Dec 2005.  http://www.slate.com/id/2133061/

[25]    “Sponsorship, Authorship, and Accountability”  Annals of Internal Medicine.  18 Sept 2001. 135(6) 483-484.  http://www.icmje.org/spon.pdf

[26]    Turner EH et al.  “Selective publication of antidepressant trials and its influence on apparent efficacy” New England Journal of Medicine.  2008 Jan 17;358(3):252-60

[27]    “Spitzer sues GlaxoSmithKline over Paxil”  Associated Press, June 2 2004. http://www.msnbc.msn.com/id/5120989/

[28]    “State of New York v. GlaxoSmithKline, No. 04401707″  New York State Supreme Court

[29]    “ASSURANCE OF DISCONTINUANCE PURSUANT TO EXECUTIVE LAW SECTION 63. SUBDIVISION 15″ http://www.oag.state.ny.us/media_center/2004/aug/aug26a_04_attach2.pdf

[30]    Cahoy, Daniel. “Medical Product Information Incentives and the Transparency Paradox”  Indiana Law Journal Vol. 82:623-671.

[31]    Toigo, T.  “Food and Drug Modernization Act (FDAMA)  Section 113: Status Report on Implementation”  Biolaw and Business VOL 7, NUMBER 2.  2004.  US Food and Drug Administration.  Washington, DC.

[32]    Harris, Gairdner.  “Report Backs Up Warnings About Drug Avandia”  New York Times, July 27 2007.

[33]    Berensen, Alex.  “Data About Zetia Risks Was Not Fully Revealed” New York Times, Dec 21 2007.

[34]    Hughes, Sue. “Concerns raised on delay of ezetimibe data”  The Heart – HeartWire.  Nov 22 2007 http://www.theheart.org/article/829507.do

[35]    McMaster W. et al.  “The Conduct of Clinical Research Under the HIPAA Privacy Rule”  Journal of Bone & Joint Surgery.  2006;88:2765-2770

[36]    Feuerstein A.  “FDA Lunches Inquiry Into Telik Trial”  TheStreet.com, June 13 2007.   http://www.thestreet.com/p/newsanalysis/biotech/10362270.html

[37]    FDAMA Section 113:  Status Report on Implementation.  US Food and Drug Administration.  August  2005  http://www.fda.gov/oashi/clinicaltrials/section113/113report/default.htm

[38]    Turner, E, Moaleji N, Arnold B.  “Closing a Loophole in the FDA Amendments Act”  Science. Vol 322 (42-45)

[39]    “TGN1412” Wikipedia.  Accessed 26 April 2009.   http://en.wikipedia.org/wiki/TGN1412

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