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 post their ends up in top-tier, peer-reviewed journals. ICMJE editors and different magazine editors require registration of scientific trial info on publicly to be had sites sooner than enrollment of analysis matters and a few nations and areas additionally require this knowledge, in addition to well timed booklet of research effects. not just does this publication speak about the genesis of those specifications, it additionally presents sensible details for researchers and sponsors on the best way to identify a workflow for a medical registry venture, the right way to dossier to a registry, and the way to put up effects. greater than 25 present internet addresses for registries are supplied in addition to a finished annotated bibliography of papers concerning medical trial registries. This ebook is a useful 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
This chapter summarizes information from discussions with several biopharmaceutical companies and is not necessarily the perspective of any one company. The chapter addresses various perspectives on the issues and options in the current debate regarding registering clinical trials at study initiation and disclosing the results of these trials at completion. The debate is ongoing and the process is evolving. Clinical trial registries According to the PhRMA, the intent of a clinical trial registry is to provide patients and healthcare providers access to information about ongoing and enrolling clinical trials, and to provide a public record and status of those clinical trials .
An all-or-none approach to disclosing clinical trial data from all trials may not be the answer. Although the ICMJE has stated that the only way to ensure clinical trial results are not “ﬁle-drawered” (a concept where results of trials are hidden from public view) is to demand that speciﬁc information be disclosed at initiation, it is possible that the best way to serve the public would be to list trials being conducted at inception (without jeopardizing innovation by requiring 20 ﬁelds), and then post the results in more detail than space constraints will allow for in journal publications.
Most registry users positively rate the amount, quality, and ease of use of registry information with few exceptions. Twenty percent of users report that ﬁnding information is difﬁcult and 17% of users report that registry information is difﬁcult to understand. These largely positive ratings may in part be because most registry users have no context or basis with which to compare quality, scope and utility of the information. These results are not entirely surprising, given the large number of autonomous and incomplete clinical trial and trial results registries combined with the rushed manner by which users ﬁnd and scan clinical trial information.
Clinical Trial Registries: A Practical Guide for Sponsors and Researchers of Medicinal Products by MaryAnn Foote (auth.), MaryAnn Foote (eds.)