By MaryAnn Foote (auth.), MaryAnn Foote (eds.)
Clinical Trial Registries: a pragmatic advisor for Sponsors and Researchers of Medicinal items is an important addition to the library of all researchers who plan to put up their leads to top-tier, peer-reviewed journals. ICMJE editors and different magazine editors require registration of scientific trial details on publicly on hand websites ahead of enrollment of research matters and a few international locations and areas additionally require this knowledge, in addition to well timed e-book of research effects. not just does this ebook talk about the genesis of those necessities, it additionally offers functional details for researchers and sponsors on the best way to identify a workflow for a scientific registry venture, how one can dossier to a registry, and the way to submit effects. greater than 25 present net addresses for registries are supplied in addition to a entire annotated bibliography of papers with regards to scientific trial registries. This booklet is a necessary resource of knowledge for all sponsors of medicinal products.
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Additional info for Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products
Which trials should be registered? As explained in the two editorials [1, 2], ICMJE wants to ensure public access to all clinical trials that test any clinical hy- The journal editor‘s perspective 19 pothesis about health intervention and its outcomes – both before and after publication of the trial. Examples of such trials are the testing a new drug or medical device against the current standard. Trials with the primary goal of assessing drug toxicity or determining pharmacokinetics of a drug are not required to be registered (phase 1 trials).
The Industry perspective on public clinical trial registries… 43 current trend for the development of separate requirements by organization and locality is neither efﬁcient nor effective. Some biopharmaceutical companies support the discussion of disclosing trial results rather than spending much of their efforts on the registration of trials at inception. The data presented on the various Web sites differ in format and the amount of data disclosed. As stated previously, the original intent of registries and results databases was to provide patients and providers with relevant information about clinical trials that may be enrolling patients; provide patients and providers with the results of a clinical trial once the trial is completed and the product is marketed; and provide transparency that each clinical trial initiated has a reported outcome.
Brief title of study X* X 11. IRB review X X 12. Condition X X 13. Intervention(s)/comparator* X* X 14. Key inclusion/exclusion criteria X X 15. Study type X X 16. Start date X X 17. Target sample size* X* X 18. Recruitment status X X 19. Primary outcome* X* X 20. Key secondary outcome* X* X *According to the WHO Technical Consultation of Clinical Trials Registration Standards, one or more of starred items may be regarded as sensitive for competitive reasons by the sponsor who may wish to delay release of the information.