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 available for free are also provided.

2023

Nelson JT, Tse T, Puplampu-Dove Y, Golfinopoulos E, Zarin DA. Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type. JAMA. 2023 Mar 30. doi: 10.1001/jama.2023.2351. [Full Text]

2022

Williams RJ, Dobbins HD, Tse T, Chon SD, Loose D, Sarosy GA, Prindiville SA, Rockhold FW, Zarin DA. Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis. BMJ. 2022 Jun 10;377:e067745. doi: 10.1136/bmj-2021-067745. [Full Text]

2020

Fain KM, Nelson J, Tse T, Williams RJ. Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications. Contemp Clin Trials. 2020 Dec 5:106237.

2019

Zarin DA, Fain KM, Dobbins HD, Tse T, Williams RJ. 10-year update on study results submitted to ClinicalTrials.gov. N Engl J Med. 2019 Nov 14; 381:1966-1974. [Full Text]

2018

Tse T, Fain KM, Zarin DA. How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider. BMJ. 2018;361:k1452. [Full Text]

Tse T, Bergeris A, Zarin DA. Lockbox for Registered Trials of Unapproved Devices. N Engl J Med. 2018 March 15;378(11):1064. [Full Text]

Fain KM, Rajakannan T, Tse T, Williams RJ, Zarin DA. Results Reporting for Trials With the Same Sponsor, Drug, and Condition in Clinicaltrials.gov and Peer-Reviewed Publications. JAMA Intern Med. 2018 Jul 1;178(7):990-992. [Full Text]

Bergeris A, Tse T, Zarin DA. Trialists' intent to share individual participant data as disclosed at ClinicalTrials.gov. JAMA. 2018 Jan 23;319(4):406-8. [Full Text]

2017

Lynch HF, Largent EA, Zarin DA. Reaping the bounty of publicly available clinical trial consent forms. IRB. 2017. Nov-Dec; 39(6). [Full Text (author manuscript)]

Zarin DA, Williams RJ, Tse T, Ide NC. The role and importance of clinical trial registries and results databases. In: Gallin JI, Ognibene FP, Johnson LL eds, Principles and Practice of Clinical Research. 4th ed. London: Academic Press; 2017: 111-25.

Dobbins HD, Cox C, Tse T, Williams RJ, Zarin DA. Characterizing Major Issues in ClinicalTrials.gov Results Submissions (Full Text). Presented at: Eighth International Congress on Peer Review and Scientific Publication; September 2017; Chicago, IL. [Poster (PDF)]

Rajakannan T, Fain KM, Williams RJ, Tse T, Zarin DA. Reporting of Sex and Gender in Clinical Trial Protocols and Published Results (Full Text). Presented at: Eighth International Congress on Peer Review and Scientific Publication; September 2017; Chicago, IL. [Poster (PDF)]

Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on trial registration 11 years after the ICMJE Policy was established. N Engl J Med. 2017 Jan 26;376(4):383-391. [Full Text]

2016

Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov - the final rule. N Engl J Med. 2016 Nov 17;375(20):1998-2004. [Full Text]

van Valkenhoef G, Loane RF, Zarin DA. Previously unidentified duplicate registrations of clinical trials: an exploratory analysis of registry data worldwide. Systematic Reviews. 2016 Jul 15;5(1):116. [Full Text]

Schwartz LM, Woloshin S, Zheng E, Tse T, Zarin DA. ClinicalTrials.gov and Drugs@FDA: A comparison of results reporting for new drug approval trials. Ann Intern Med. 2016 Sept 20;165(6):421-30. [Full Text]

Bourgeois FT, Olson KL, Tse T, Ioannidis JP, Mandl KD. Prevalence and characteristics of interventional trials conducted exclusively in elderly persons: A cross-sectional analysis of registered clinical trials. PLoS One. 2016 May 19;11(5):e0155948. [Full Text]

Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med. 2016 Jan 19;13(1):e1001946. [Full Text]

2015

Zarin DA, Tse T, Ross JS. Trial-results reporting and academic medical centers. N Engl J Med. 2015 Jun 11;372(24):2371-2. [Full Text]

Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated trials in the ClinicalTrials.gov results database: Evaluation of availability of primary outcome data and reasons for termination. PLoS One. 2015 May 26;10(5):e0127242. [Full Text]

Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015 Mar 17;313(11):1163-5. [Full Text]

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. [Full Text (author manuscript)]

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

Zarin DA, Tse T, Dobbins HD. Beyond feasibility: Assessing the ClinicalTrials.gov results database (Abstract). 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. [Full Text]

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

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 (PDF). 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 (Abstract). 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

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

2007

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]

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) Note: The article is freely available, but users must click on the green "Download PDF" button to access it.]

2000

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

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]

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)]