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Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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7 Enhancing the Value of Clinical Trial Registration
Pages 54-57

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From page 54...
... A major focus of the IOM report was improved communication with the public. ClinicalTrials.gov is already a valuable resource to the public; however, the modifications proposed in Recommendation 4.11 were 1This chapter is based on the presentation of Deborah Zarin, Director, ClinicalTrials.gov, National Library of Medicine.
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From page 55...
... Dr. Zarin discussed the resource challenges of what she identified as four components of Recommendation 4.11, noting that none of those components will be easy to implement: • Expanded scope of mandatory trial registration -- The system has yet to reach a steady state, and could readily handle an increase in the number of trials registered without requiring a significant budget increase (Figure 7-1)
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From page 56...
... An example of how a policy change could improve this situation is Maine's recent bill requiring drug companies to post a form indicating all previous names or aliases of each drug. • Addition of a results database -- ClinicalTrials.gov is already linked to published results whenever possible and could be linked to drugs@fda if trial identifiers were used.
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From page 57...
... The current mandates for registration include the Food and Drug Modernization Act, Section 113, which mandates register ing all Investigational New Drug (IND) studies with efficacy end points for serious and life-threatening conditions, and the above-mentioned requirement of the International Committee of Medical Journal Editors to register trials for any intervention that is clinically directed as a condi tion for publication.
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