This research initiative can be divided into three general areas: cross-cutting issues related to clinical research information dissemination;trial registration;and results reporting. Our research focuses on the following: Cross-Cutting Issues Develop systems that facilitate comprehensive search and retrieval of relevant trials by a variety of users Develop systems that insert informative links from trial records to relevant content on other sites Investigate methods for harmonizing policies internationally in order to foster development of a comprehensive database with search functions that can help users to identify all trials, world-wide, that meet their search criteria Enhance usability, accessibility, and other support features to support international set of users Evaluate impact of registry and results database on public, researchers, and other clinical and policy decision-makers Registration Issues Develop methods for unique trial identification, including prevention of duplicate registrations, and work with other systems (e.g., MEDLINE) to implement widespread use of ClinicalTrials.gov unique ID (NCT number) Develop methods for summarizing key aspects of study protocols Improve methods for uniquely identifying interventions, including drugs, devices and biologics;develop and maintain a thesaurus of synonyms to optimize search functions Optimize methods for reporting pre-specified outcome measures, including identifying key sub-components and developing rules and guidelines to ensure valid entries Results Reporting Issues Enhance framework for collecting summary study results data from the full range of human subjects research; Identify and determine methods for accommodating specific study types (e.g., diagnostic accuracy studies, adaptive study designs, dose-ranging studies) Develop study display screens that are structured, convey key information, and provide useful resource information while minimizing opportunities for bias and misunderstanding Apply the Consolidated Standards of Reporting Trials (CONSORT) statements and other study reporting guidelines to ensure that optimal data entry can be achieved Work with domain-specific expert groups to develop banks of useful baseline and outcome measures Evaluate quality control methods for determining whether results records meet minimal database requirements.
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