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By Institute of Medicine, Board on Health Sciences Policy, Committee on Clinical Trial Registries

Presents workshop record of the Committee on medical Trial Registries Board on health and wellbeing Sciences coverage held June 27, c2005. issues contain the necessity for medical trial registries, present registry actions, content material of a medical trial registry, implementation concerns, and extra. For researchers. Softcover.

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Extra info for Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report

Sample text

Trial Phase 6. , interventional) 7. , enrolling, completed) 8. , drug, vaccine) 9. Condition or Disease 10. Key Eligibility Criteria (including gender and age) 11. Location of Clinical Trial 12. Contact Information* 13. Estimated Target Number of Subjects CONTENT OF A CLINCIAL TRIAL REGISTRY 27 # Clinical Trial Data Field Description—to be registered prior to the first patient visit in a study 14. Hypothesis Statement: Statement of Intervention(s) and Comparison(s) Studied 15. Definition of Primary and Secondary Outcome Measures 16.

Comments on the Timing and Content for Reporting Results of Trials The journal editors explained why the ICMJE did not call for describing the results of trials in a trial registry. Dr. Sox stated that they are more concerned with recording the existence of a trial and some basic data. ” Dr. Drazen added that, if you know about a trial, you have the opportunity to query what happened with the trial. ” The editors also expressed concern that showing the results of poorly done clinical trials is a disservice to the public.

Study Type 6. Secondary Sponsor(s) 16. Anticipated Trial Start Date 7. Responsible Contact Person 17. Target Sample Size 8. Research Contact Person 18. Recruitment Status 9. Title of the Study 10. Official Scientific Title of the Study 19. Primary Outcome 20. Key Secondary Outcomes 12 DEVELOPING A NATIONAL REGISTRY JOINT PHARMACEUTICAL INDUSTRY POSITION In describing the joint position published by the international pharmaceutical industry, Dr. S. pharmaceutical industry had been considering guidelines for registries before the international position was adopted.

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