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5 Implementation Issues
Pages 35-42

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From page 35...
... · Define what clinical trial results information will be posted to a registry for completed clinical trials.
From page 36...
... Pending NIH grant applications and unfunded new and competing continuations and competing supplemental applications are withheld, as is "information which, if released, would adversely affect the competitive position of the person or organization." These rules govern NIH basic and clinical research, including clinical trials. For reasons similar to those motivating the need to create broad clinical trial registries, FOIA was created in 1966 to give the public expansive access to the records and information in the possession and control of U.S.
From page 37...
... Zarin has not been able to get a clear reading as to whether those protocols could be obtained through FOIA until there is a test case. "There's a fair amount of uncertainty about how that would work and what would actually happen." Gail Cassell, Vice President of Scientific Affairs of Eli Lilly and a member of the Board on Health Sciences Policy (HSP)
From page 38...
... Therefore it seems evident that a deterrent is needed to protect against failure to post required clinical trial information to a central registry and against promoting unauthorized uses of a drug in the registry. Mechanisms to ensure compliance are necessary to maintain the integrity and reliability of the clinical trial registry.
From page 39...
... The New York Attorney General recently used the same mechanism in several high-profile cases involving the pharmaceutical and other industries. Of course, failure to register the clinical trial would also likely preclude publication of the data in a leading medical journal.
From page 40...
... Alan Breier, Vice President, Medical and Chief Medical Officer of Eli Lilly and Company, suggested two ways to ensure compliance while protecting proprietary information: (1) The study protocol and related amendments could be placed in a secure repository managed by an independent third party and the study summary could be matched to the protocol; or (2)
From page 41...
... She also predicted redundancy in the case of multisite studies with multiple IRBs. John Schneider, Chair of the Council on Scientific Affairs of the American Medical Association, stated that using IRBs makes sense if their only job is to look for a unique identifier, indicating the trial has been registered.
From page 42...
... It was also noted that the FDA has some of the data that would be needed by a clinical trial registry.


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