Developing a National Registry of Pharmacologic and Biologic Clinical Trials Workshop Report (2006) / Chapter Skim
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3 Current Registry Activities
3 Current Registry Activities
Pages 9-18
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From page 9... ...
conducting clinical trials of experimental treatments (drugs or biologics) for serious or life-threatening diseases and conditions have been required to submit certain information to the public clinical trial registry ClinicalTrials.gov.
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From page 10... ...
For these reasons, several groups have called for the mandatory registration of additional clinical trials as well as the registration of more extensive clinical trial information and the posting of a summary of clinical trial results. In addition, a number of clinical trial registries have been created in the public sector and by several pharmaceutical companies.
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From page 11... ...
Official Scientific Title of the 20. Key Secondary Outcomes Study
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Registration would occur within 21 days of the initiation of patient enrollment. To reduce occurrence of "the file drawer phenomenon," the joint pharmaceutical industry position also committed to make the following outcomes information available on a public registry: · The results of all clinical trials, other than exploratory trials, conducted on a drug that is approved for marketing and is com mercially available in at least one country will be registered, re gardless of outcome.
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From page 13... ...
THE WORLD HEALTH ORGANIZATION PROJECT As the IOM was carrying out its discussions, WHO began work to set standards for a global clinical trial registry platform that would act as an umbrella for existing national registries. At the June 27 IOM workshop, a WHO representative presented the international position on clinical trial registration developed in April 2005 by global representatives of the medical journals, academia, public health, regulatory arena, the Cochrane Collaboration, and the pharmaceutical industry.
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From page 14... ...
14 Key Inclusion and Exclusion Key Inclusion and Exclusion Criteria Criteria 15 Study Type Study Type 16 Anticipated Trial Start Date Date of First Enrollment 17 Target Sample Size Target Sample Size 18 Recruitment Status Recruitment Status at Time of UTRN [Universal Trial Reference Number] Request 19 Primary Outcome Primary Outcome(s)
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From page 15... ...
Sponsors of privately and publicly funded clinical trials would be required to provide public access to basic information on studies before they begin and to provide public access to the results of clinical studies, including primary and secondary outcomes and significant adverse events. It would also create penalties for noncompliance.
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From page 17... ...
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