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ClinicalTrial Registration and Results Reporting

$937,572Z01FY2008LMNIH

National Library Of Medicine

Investigators

Linked publications, trials & patents

Abstract

This research initiative can be divided into three general areas: trial registration; results reporting; and cross-cutting issues related to trial information dissemination. Our research focuses on the following:[unreadable] [unreadable] Cross-Cutting Issues[unreadable] Development of systems that facilitate comprehensive search and retrieval of relevant trials by a variety of users[unreadable] Development of systems that can insert links from trial records to relevant information from other sites[unreadable] Investigate methods for harmonizing policies internationally in order to foster development of comprehensive database with search function that can help users to identify all trials, world-wide, that meet their search criteria[unreadable] Enhance usability, accessibility, and other support features to support international set of users[unreadable] Evaluate impact of registry and results database on public, researchers, and other clinical and policy decision-makers[unreadable] [unreadable] Registration Issues[unreadable] Develop methods for assigning a unique ID and work with other systems (e.g., MEDLINE) to implement widespread use of ID[unreadable] Develop methods for summarizing key aspects of study protocols[unreadable] Improve methods for uniquely identifying interventions, including drugs, devices and biologics; develop and maintain thesaurus of synonyms to optimize search functions[unreadable] Optimize methods for reporting pre-specified outcome measures, including identifying key sub-components and developing rules and guidelines to ensure valid entries[unreadable] [unreadable] Results Reporting Issues[unreadable] Develop framework for collecting summary data re: study results from the full range of human subjects research; [unreadable] Identify key elements of all clinical research study summary results [unreadable] Identify and determine methods for accommodating special study types (e.g., diagnostic accuracy studies, adaptive study designs, etc)[unreadable] Develop study display screens that are structured, and that convey key information while minimized opportunities for bias and misunderstanding[unreadable] Apply CONSORT and other study reporting guidelines to system to ensure that optimal data entry can be achieved

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