This research initiative can be divided into four general areas: cross-cutting issues related to clinical research information dissemination;trial registration;results reporting;and collaborations. Our research focuses on the following: 1. Cross-Cutting Issues a) Develop systems that facilitate comprehensive structured search and retrieval of relevant study records by a variety of users with different levels of experience and needs. b) Develop systems that insert informative links from trial records to relevant content on other high-quality sites c) Investigate methods for harmonizing policies and procedures internationally in order to foster development of: (1) a comprehensive database with search functions that allow users to identify all registered studies, worldwide, that meet their search criteria (e.g., WHO) and (2) unified mechanisms for the reporting and displaying summary results across results databases (e.g., EMA) d) Enhance usability, accessibility, and other features to support international users e) Evaluate the impact of registry and results database on the public, researchers, and other clinical and policy decision-makers f) Streamline and enhance guidance, educational, and outreach material resources and customer service infrastructure to provide enhanced support for data providers, database users, and others g) Streamline and enhance the ClinicalTrials.gov study record review process, which is designed to focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting 2. Registration Issues a) Develop methods for unique study identification, including prevention of duplicate registrations, and work with other systems (e.g., MEDLINE) to implement widespread use of ClinicalTrials.gov Identifier (NCT Number) b) Develop methods for summarizing key aspects of study protocols, including amount of information, degree of structured data, and level of granularity to characterize the study sufficiently to satisfy a variety of users and needs c) Improve methods for uniquely identifying intervention names and types, including drugs, devices, and biologics;develop and maintain a thesaurus of synonyms to optimize search functions d) Optimize methods for reporting pre-specified outcome measures, including identifying key sub-components and developing rules and guidelines to ensure valid entries 3. Results Reporting Issues a) Enhance framework for collecting summary study results data and descriptors from the full range of clinical research involving human subjects; b) Identify and determine methods for accommodating specific study types (e.g., diagnostic accuracy studies, adaptive study designs, dose-ranging studies) c) Develop study display screens that are structured, convey key information, and provide useful resource information while minimizing opportunities for bias and misunderstanding d) Apply the Consolidated Standards of Reporting Trials (CONSORT) statements and other study reporting guidelines to ensure that optimal data entry can be achieved e) Work with domain-specific experts and professional groups to develop banks of useful baseline and outcome measures f) Evaluate and establish minimal data requirements for submissions to results databases 4. Collaborations a) Develop mechanisms to enhance the utility of ClinicalTrials.gov data for researchers, including search (academic site), display (tabular view), and standardized data sets (e.g., CTTI) b) Investigate potential trends and practices in the clinical research enterprise in the US and worldwide using the database Identify and suggest best practices in reporting information on clinical research c) Develop relationships with individuals and entities to promote clinical study registration and results reporting and to disseminate information about existing laws/policies as well as suggested best practices

Project Start
Project End
Budget Start
Budget End
Support Year
6
Fiscal Year
2013
Total Cost
$626,649
Indirect Cost
Name
National Library of Medicine
Department
Type
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Hartung, Daniel M; Zarin, Deborah A; Guise, Jeanne-Marie et al. (2014) Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med 160:477-83
Zarin, Deborah A; Tse, Tony; Menikoff, Jerry (2014) Federal human research oversight of clinical trials in the United States. JAMA 311:960-1
Zarin, Deborah A; Tse, Tony (2013) Clarification about ClinicalTrials.gov. IRB 35:19
Zarin, Deborah A (2013) Participant-level data and the new frontier in trial transparency. N Engl J Med 369:468-9
Zarin, Deborah A; Tse, Tony (2013) Unambiguous identification of obesity trials. N Engl J Med 368:580-1
Zarin, Deborah A; Tse, Tony (2013) Trust but verify: trial registration and determining fidelity to the protocol. Ann Intern Med 159:65-7
Zarin, Deborah A; Tse, Tony; Williams, Rebecca J et al. (2011) The ClinicalTrials.gov results database--update and key issues. N Engl J Med 364:852-60
Tse, Tony; Williams, Rebecca J; Zarin, Deborah A (2009) Reporting "basic results" in ClinicalTrials.gov. Chest 136:295-303
Tse, Tony; Williams, Rebecca J; Zarin, Deborah A (2009) Update on Registration of Clinical Trials in ClinicalTrials.gov. Chest 136:304-5