Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Selected Publications

This page contains links to scholarly publications about ClinicalTrials.gov and clinical research, written by ClinicalTrials.gov staff and others. Titles of journal articles link to the PubMed® abstract for the publication, when available. Links to full-text versions of articles that are freely available are also provided.

2015

Zarin DA, Tse T, Sheehan J. The proposed rule for U.S. clinical trial registration and results submission. N Engl J Med. 2015 Jan 8;372(2):174-80.[Full Text]

2014

Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014 Apr 1;160(7):477-83.

Zarin DA, Tse T, Menikoff J. Federal human research oversight of clinical trials in the United States. JAMA. 2014 Mar 5;311(9):960-1. [Full Text]

2013

DiPiazza K, Williams RJ, Zarin DA, Tse T. Terminated trials in ClinicalTrials.gov: Characteristics and evaluation of reasons for termination (Full Text). Presented at: Seventh International Congress on Peer Review and Biomedical Publication; September 2013; Chicago, IL. [Full Text (PDF)]

Zarin DA, Tse T, Dobbins HD. Beyond feasibility: Assessing the ClinicalTrials.gov results database (Full Text). Presented at: Seventh International Congress on Peer Review and Biomedical Publication; September 2013; Chicago, IL. [Full Text (PDF)]

Zarin DA. Participant-level data and the new frontier in trial transparency [editorial]. N Engl J Med. 2013 Aug 1;369(5):468-9.

Zarin DA, Tse T. Trust but verify: trial registration and determining fidelity to the protocol. Ann Intern Med. 2013 Jul 2;159(1):65-7. [Full Text]

Zarin DA, Tse T. Clarification about ClinicalTrials.gov. IRB. 2013 May-Jun;35(3):19. [Full Text]
(Note: The article is free, but users must register to access it.)

Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to publication among completed clinical trials. JAMA Intern Med. 2013 May 13:1-3. doi:10.1001/jamainternmed.2013.136. [Full Text]

Zarin DA, Williams RJ, Bergeris AM, Dobbins H, Ide NC, Loane RF, Robbins A, Tse T. ClinicalTrials.gov and Related Projects: Improving Access to Information about Clinical Trials; A report to the Board of Scientific Counselors. Bethesda, MD: Lister Hill National Center for Biomedical Communications, US National Library of Medicine; April 2013. Technical Report TR-2013-001. [Full Text (PDF)]

Zarin DA, Tse T. Unambiguous identification of Obesity Trials. N Engl J Med. 2013; 368:580-1. [Full Text]

2012

Huston M, Williams RJ, Bergeris A, Fun J, Tse T. New Style and New Content for ClinicalTrials.gov (Full Text). NLM Tech Bull. 2012 Jul-Aug;(387):e5.

Wong E, Williams R. ClinicalTrials.gov: Requirements and implementation strategies (Full Text) Regulatory Focus. 2012 May. [Full Text (PDF)]

Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012;307(17):1838-47. [Full Text]

Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross-sectional analysis. BMJ. 2012;344:d7292. [Full Text]

Tse T, Zarin DA, Williams RJ, Ide NC. The role and importance of clinical trial registries and results databases. In: Gallin JI, Ognibene FP, eds, Principles and Practice of Clinical Research. 3rd ed. Amsterdam: Academic Press; 2012: 171-81.

2011

Zarin DA, Tse T. The effect of funding source on outcome reporting among drug trials [letter]. Ann Intern Med. 2011 Jan 18;154(2):137-8.

Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364(9):852-60. [Full Text]

2010

Williams RJ, Tse T, Harlan WR, Zarin DA. Registration of observational studies: Is it time? CMAJ. 2010;182(15):1638-42. [Full Text]

Zarin DA, Califf R. Point Counterpoint: ClinicalTrials.gov: Bureaucratic nuisance or opportunity to improve the field? (Full Text, PDF). APOR. 2010;6(2):3-5.

2009

Williams RJ, Tse T. ClinicalTrials.gov: A public database of clinical research. Presented at: American Public Health Association 137th Annual Meeting and Expo; November 2009; Philadelphia, PA. [Poster (PDF)]

Williams RJ, Tse T, Zarin DA. Characterizing sponsor-imposed restrictions on disclosing results of clinical trials (Full Text). Presented at: Sixth International Congress on Peer Review and Biomedical Publication; September 2009; Vancouver, BC, Canada. [Poster (PDF)]

Zarin DA, Tse T, Williams RJ. Frequency and nature of changes in primary outcome measures (Full Text). Presented at: Sixth International Congress on Peer Review and Biomedical Publication; September 2009; Vancouver, BC, Canada.

Tse T, Zarin DA. Clinical trial registration and results reporting: ClinicalTrials.gov and FDAAA (Full Text, PDF). FDLI Update. 2009;1:18-22.

Tse T, Williams RJ, Zarin DA. Reporting "Basic Results" in ClinicalTrials.gov. Chest. 2009;136(1):295-303. [Full Text]

Tse T, Williams RJ, Zarin DA. Update on registration of clinical trials in ClinicalTrials.gov. Chest. 2009;135:304-5. [Full Text]

2008

Tse T, Williams RJ. ClinicalTrials.gov to include basic results data (Full Text). NLM Tech Bull. 2008 Sep-Oct;(364):e15.

Zarin DA, Tse T. Moving towards transparency of clinical trials. Science. 2008;319(5868):1340-2. [Full Text (author manuscript)]

2007

Williams RJ, Tse T. New look for ClinicalTrials.gov (Full Text). NLM Tech Bull. 2007 Sep-Oct;(358):e2.

Drazen JM, Zarin DA. Salvation by registration [editorial]. N Engl J Med. 2007 Jan 11;356(2):184-5. [Full Text]

Ide NC, Loane RF, Demner-Fushman D. Essie: A concept-based search engine for structured biomedical text. J Am Med Inform Assoc. 2007;14(3):253-63. [Full Text]

Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA. Issues in the registration of clinical trials. JAMA. 2007;297(19):2112-20.

Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):909-12. [Full Text]

2006

Graham L, Tse T, Keselman A. Exploring user navigation during online health information seeking. AMIA Annu Symp Proc. 2006:299-303. [Full Text (PDF)]

2005

Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med. 2005 Dec 29;353(26):2779-87. [Full Text]

Ripple A, Tse T, Zarin DA. ClinicalTrials.gov scope expanded (Full Text). NLM Tech Bull. 2005 Jul-Aug;(345):e6.

Zarin DA, Bergeris A, Ide NC, Tse T. ClinicalTrials.gov; A report to the Board of Scientific Counselors. Bethesda, MD: Lister Hill National Center for Biomedical Communications, US National Library of Medicine; May 2005. Technical Report LHNCBC-TR-2005-003. [Full Text (PDF)]

2004

Gillen JE, Tse T, Ide NC, McCray AT. Design, implementation and management of a web-based data entry system for ClinicalTrials.gov. Stud Health Technol Inform. 2004;107(Pt 2):1466-70. [Full Text (PDF)]

2002

Tse T, Johnson SO, Ripple A. Update: Expanded ClinicalTrials.gov search capabilities (Full Text). NLM Tech Bull. 2002 Jul-Aug;(327):e5.

2000

McCray AT. Better access to information about clinical trials. Ann Intern Med. 2000 Oct 17;133(8):609-14. [Full Text]

Tse T. Searching ClinicalTrials.gov (Full Text). NLM Tech Bull. 2000 Sep-Oct;(316):e1.

McCray AT, Ide NC. Design and implementation of a national clinical trials registry. J Am Med Inform Assoc. 2000 May-Jun;7(3):313-23. [Full Text]
(Note: The article is free, but users must register to access it.)

McCray AT, Dorfman E, Ripple A, Ide NC, Jha M, Katz DG, Loane RF, Tse T. Usability issues in developing a Web-based consumer health site. Proc AMIA Symp. 2000:556-60. [Full Text (PDF)]

This page last reviewed in February 2015