Summary
It is unclear where this debate is headed and how it will be resolved. It is important to remember that patients’ needs are quite different from the research community’s when it comes to clinical trial registries. The patient is interested in the number of different trials, the enrollment criteria, and the geographical proximity of the trial site so that he/she can make a decision about whether the trial is of potential interest. These are a mere subset of the 20 data elements that are under discussion and have little bearing on the transparency of clinical research that the remaining data elements are designed to address. p ]Finally, the role of the FDA must be fully recognized for what it is, an impartial review of all the data required to support a marketing application. Those who castigate the pharmaceutical industry indirectly impugn the integrity of the FDA. Pharmaceutical industry clinical research goes forward with the full knowledge that trial design and results will be critically examined. A product will not be licensed for marketing nor will an advertising claim be permitted unless the data support it.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
DiMasi JA, Hansen RW, Grabowski HG (2003) The price of innovation, new estimates of drug development costs. J Health Econ 22: 151–185
ICH. Good Clinical Practice Guidelines; Guidance Document E-6(R1). Available at: www.ich.org (Accessed 23 April 2006)
Prescription Drug User Fee Act. Available at: http://www.fda.gov/cder/pdfua/default.htm (Accessed 23 April 2006)
Fiscal Year 2003 data. Available at: http://www.fda.gov/cder/pdufa_costs.htm (Accessed 23 April 2006)
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)
Pharmaceutical Research and Manufacturers of America. Principles for registering clinical trials. Available at: http://www.phrma.org/publications/policy_papers/phrma_clinical_trial_registry_proposal (Accessed 23 April 2006)
DeAngelis C, Drazen JM, Frizelle FA et al (2004) Clinical trial registration: A statement from the International Committee of Medical Journal Editors. N Engl J Med 351: 1250–1251
Pharmaceutical Research and Manufacturers of America. Principles on conduct of clinical trials and communication of clinical trial results. Available at: http://www.phrma.org/clinical_trials (Accessed 23 April 2006)
World Health Organisation. International Clinical Trial Registry Platform. Available at www.who.int/icrtp/en (Accessed 23 April 2006)
DeAngelis C, Drazen JM, Frizelle FA et al (2005) Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. N Engl J Med 352: 2436–2438
World Health Organisation. WHO Consultation. Available at: http://www.who.int/ictrp/news/ictrp_sag_meeting_april2005_conclusions.pdf (Accessed 23 April 2006)
World Health Organisation. Comment solicitation. Available at: http://www.who.int/ictrp/comments4/en/print.html (Accessed 23 April 2006)
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2006 Birkhäuser Verlag Basel/Switzerland
About this chapter
Cite this chapter
Goldhammer, A. (2006). Transparency and validity of pharmaceutical research. In: Foote, M. (eds) Clinical Trial Registries. Birkhäuser Basel. https://doi.org/10.1007/978-3-7643-7583-6_7
Download citation
DOI: https://doi.org/10.1007/978-3-7643-7583-6_7
Publisher Name: Birkhäuser Basel
Print ISBN: 978-3-7643-7578-2
Online ISBN: 978-3-7643-7583-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)