Pray, Leslie, Robinson, Sally. "7 Enhancing the Value of Clinical Trial Registration." Challenges for the FDA: The Future of Drug Safety, Workshop Summary. Washington, DC: The National Academies Press, 2007.
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Challenges for the FDA: The Future of Drug Safety - Workshop Summary
FIGURE 7-2 New trials received by ClinicalTrials.gov in 2006. The average total number of new trial registrations received per month was 923; the average number of open drug trials received per month was 478; the average number of open industry drug trials received per month was 215; and the average number of open industry IND trials received per month was 162.
NOTE: IND = Investigational New Drug.
SOURCE: Zarin, 2007.
When questioned about the history and mandate of the ClinicalTrials. gov registry, Dr. Zarin responded that the registry has been functioning since 2000, although some sponsors (NIH and some drug companies) have registered older studies. The current mandates for registration include the Food and Drug Modernization Act, Section 113, which mandates registering 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 condition for publication. Again, one of the challenges is determining whether a trial that is mandated to be registered is actually registered. In response to another question, Dr. Zarin noted that while ClinicalTrials.gov accepts and welcomes data on nonclinical trials (i.e., observational data), it cannot enforce their inclusion.