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Appendix E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases
Pages 91-94

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From page 91...
... E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases1 The innovative pharmaceutical industry, which is represented worldwide by the European Federation of Pharmaceutical Industries and Associations (EFPIA) , the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
From page 92...
... 92 DEVELOPING A NATIONAL REGISTRY · All clinical trials, other than exploratory trials,2 should be submitted for listing in a free, publicly accessible clinical trial registry within 21 days of the initiation of patient enrollment, unless there are alternative national requirements. · The registry should contain basic information about each trial sufficient to inform interested subjects (and their health care practitioners)
From page 93...
... APPENDIX E 93 industry commits to make the following information available on completed clinical trials: · The results of all clinical trials, other than exploratory trials,2 conducted on a drug that is approved for marketing and is commercially available in at least one country should be publicly disclosed on a free, publicly accessible, clinical trial results database, regardless of outcome. Trial results from exploratory trials also should be publicly disclosed if they are deemed to have significant medical importance and may have an impact on a marketed product's labeling.
From page 94...
... 94 DEVELOPING A NATIONAL REGISTRY Implementation Dates · Trials initiated on or after July 1, 2005, and meeting the above requirements should be included in a clinical trial registry. · Ongoing clinical trials meeting the above requirements should be included in a clinical trial registry by September 13, 2005.

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