ClinicalTrial Registration and Results Reporting

Zarin, Deborah

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: Cross-Cutting Issues Develop systems that facilitate comprehensive search and retrieval of relevant trials by a variety of users Develop systems that insert links from trial records to relevant information from other sites 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 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 assigning a unique ID, including prevention of duplicate registrations, and work with other systems (e.g., MEDLINE) to implement widespread use of ID Develop methods for summarizing key aspects of study protocols Improve methods for uniquely identifying interventions, including drugs, devices and biologics; develop and maintain 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 Develop framework for collecting summary study results data from the full range of human subjects research; Identify key elements of all clinical research study summary results Identify and determine methods for accommodating special study types (e.g., diagnostic accuracy studies, adaptive study designs, etc) Develop study display screens that are structured, and that convey key information while minimized opportunities for bias and misunderstanding Apply the Consolidated Standards of Reporting Trials (CONSORT) statement and other study reporting guidelines to system to ensure that optimal data entry can be achieved

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Library of Medicine (NLM)
• Type: Investigator-Initiated Intramural Research Projects (ZIA)
• Project #: 1ZIALM008926-02
• Application #: 7969232
• Support Year: 2
• Fiscal Year: 2009
• Total Cost: $792,577

Institution

• Name: National Library of Medicine

Publications

Zarin, Deborah A; Tse, Tony; Ross, Joseph S (2015) Trial-results reporting and academic medical centers. N Engl J Med 372:2371-2

Williams, Rebecca J; Tse, Tony; DiPiazza, Katelyn et al. (2015) Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. PLoS One 10:e0127242

Zarin, Deborah A; Tse, Tony; Sheehan, Jerry (2015) The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med 372:174-80

Gopal, Anand D; Desai, Nihar R; Tse, Tony et al. (2015) Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA 313:1163-5

Zarin, Deborah A; Tse, Tony; Menikoff, Jerry (2014) Federal human research oversight of clinical trials in the United States. JAMA 311:960-1

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 (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) Trust but verify: trial registration and determining fidelity to the protocol. Ann Intern Med 159:65-7

Zarin, Deborah A; Tse, Tony (2013) Unambiguous identification of obesity trials. N Engl J Med 368:580-1