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ClinicalTrials.gov Modernization

Contents

The National Library of Medicine (NLM) has launched an effort to modernize ClinicalTrials.gov to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. This page will be updated as information becomes available related to the ClinicalTrials.gov Modernization effort.

About

NLM Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization

  • The NLM Board of Regents was established to serve as the advisory body to the Secretary, HHS; Assistant Secretary for Health; Director, NIH; and the Director, NLM, on all important aspects of policy regarding the Library and is the final review body for NLM's extramural grant program. The NLM Board of Regents Public Service Working Group on ClinicalTrials.gov modernization was established September 2019 and relevant meeting materials can be found on the NLM Board of Regents webpage.
  • Working Group Member Bios: Descriptions of the members of the Public Service Working Group on ClinicalTrials.gov Modernization. (PDF; October, 2022).

Request for Information (RFI)

  • NLM: ClinicalTrials.gov Summary of Responses to the RFI (PDF; April 28, 2020): This report provides a high-level summary of the responses received for each question posed in the RFI. It also describes the main themes of the suggestions for modernizing ClinicalTrials.gov. Note that NLM did not correct any of the comments or address or comment on their contents. These preliminary analyses will be complemented by additional, in-depth, quantitative and qualitative analyses of the feedback received. NLM will use the input from the RFI, as well as from additional stakeholder engagement, user interviews, and the public meeting on April 30, 2020, to inform its roadmap for modernizing ClinicalTrials.gov.
  • NLM: Public Comments Received in Response to Request for Information (RFI): ClinicalTrials.gov Modernization (PDF; April 28, 2020): This document consolidates the 268 responses received in response to the RFI without change, including name and affiliation of commenter. The full text of the comments and attachments are listed in the order in which they were received.
  • NLM: Request for Information (RFI): ClinicalTrials.gov Modernization (December 30, 2019) accepted comments between December 30, 2019 and March 14, 2020.

Beta Release Updates

ClinicalTrials.gov Beta

  • January 31, 2023: ClinicalTrials.gov Beta now includes a new draft design of the application programming interface (API). We've also added resources for using the API. To learn more, please read the latest Release Notes.
  • December 19, 2022: ClinicalTrials.gov Beta now has a streamlined search experience, and study records have a new Record History tab, making it easier to view changes to the record. To learn more, please read the latest Release Notes.
  • November 17, 2022: ClinicalTrials.gov Beta now has an expanded and customizable table view of search results, with columns for additional data elements and the ability to select and reorder the columns displayed onscreen. Printer-friendly layouts for selected study records and the card view of search results have also been added. To learn more, please read the latest Release Notes.
  • August 22, 2022: A new, improved search experience was added to ClinicalTrials.gov Beta, along with a table view for search results. To learn more, please read the Release Notes.
  • April 27, 2022: ClinicalTrials.gov Beta includes expanded access records, FDAAA 801 Violation information, other improvements, and fixes. To learn more, please read the Release Notes.
  • March 8, 2022: ClinicalTrials.gov Beta has new features and key improvements such as additional fields on the study record, more prominent publications, study documents when available, and a Release Notes Page for future updates.
  • December 8, 2021: The first release of the ClinicalTrials.gov Beta website has launched. It includes a responsive site design that better supports mobile-device users and adds information presented in plain language. This release focuses on basic features, with more features to be added over time, based on user input.

PRS Beta

  • January 26, 2023: Updates in the PRS Test System include several more modules in the Protocol Section, including the Study Design, Eligibility, and References modules, along with new or updated help content available onscreen and in slide-out drawers. To learn more, please read the latest Release Notes.
  • December 15, 2022: Additional modules, with new or updated onscreen guidance, have been added to the Protocol Section in the PRS Test System. To learn more, please read the latest Release Notes.
  • November 10, 2022: PRS Beta has been updated in the PRS Test System to include two modules from the Protocol Section. These redesigned modules feature on-demand help tips and guidance to make the data elements more understandable. To learn more, please read the latest Release Notes.
  • July 6, 2022: Updates in PRS Beta, including the Planning View and Public Site View for PRS Administrators, are now available in the PRS Test System and will be available in the PRS on July 14, 2022. Improvements also include greater accessibility and the addition of a Group column for PRS Administrators. To learn more, read the Release Notes.
  • May 9, 2022: Updates in PRS Beta, including improvements to functionality of the Record List and additions of helpful tips to the About PRS Beta help document, are now available in the PRS Test System and will be available in the PRS on May 20, 2022. See the Release Notes Page in PRS Beta under "About" to learn more.
  • January 27, 2022: PRS Beta is now available in the PRS Test System and will be available in the PRS on February 3, 2022. This release consists of new workflow and portfolio management features such as a customizable display and multiple download options to help data submitters save time. A pre-recorded demonstration of this release is also available.

Resource Materials

  • December 19, 2022: Prerecorded demonstration videos of the PRS Beta and ClinicalTrials.gov Beta are available. These videos present features of the beta sites and highlight changes from the classic sites.
    • ClinicalTrials.gov Protocol Registration and Results System (PRS) Beta Demonstration presented by Stacey Arnold, PhD, PRS Subject Matter Expert. The video highlights key features of the PRS Beta website related to the Record List, including customizing Record List views, filtering Record List columns, and using the advanced filtering options. (October 2022)
    • ClinicalTrials.gov Beta Demonstration presented by Christina Robinson, MA, ClinicalTrials.gov Beta Product Owner. The video highlights key features of the ClinicalTrials.gov Beta website related to conducting a search, the search results, and the study record page. (October 2022)

Events

  • Webinar: ClinicalTrials.gov Modernization and Beta Sites Progress (57:40): This webinar provided an update on the progress of the modernization effort, an overview of the ClinicalTrials.gov Beta and Protocol Registration and Results System (PRS) Beta websites, and a live Q&A. Presented by Anna M. Fine, PharmD, MS, Acting Director, ClinicalTrials.gov; Christina Robinson, MA, ClinicalTrials.gov Beta Product Owner; and Nachiket Dharker, PhD, PRS Beta Product Owner. (October 27, 2022)
  • Webinar: ClinicalTrials.gov Modernization Update and Beta Website Demonstration (40:29): This webinar provides an update on the modernization effort and a demonstration of the beta ClinicalTrials.gov website. Presented by Anna M. Fine, PharmD, MS, Acting Director, and Christina Robinson, MA, Beta Website Product Owner, ClinicalTrials.gov, NLM. (December 10, 2021)
  • Webinar: ClinicalTrials.gov Modernization Beta Preview (30:29): This webinar provides an update on modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov. Presented by Rebecca Williams, PharmD, MPH, Acting Director, ClinicalTrials.gov, NLM. (October 07, 2021)
  • Webinar: ClinicalTrials.gov Modernization Update (1:02:02): This webinar describes the progress of the modernization effort and what's next. Presented by Rebecca Williams, PharmD, MPH, Acting Director, ClinicalTrials.gov, NLM. (February 18, 2021)
  • Webinar: Learn About ClinicalTrials.gov Modernization and How to Provide Input (30:35): This webinar describes the modernization efforts, the Request for Information (RFI), and ways to share your feedback. Presented by Rebecca Williams, PharmD, MPH, Acting Director, ClinicalTrials.gov, NLM. (January 22, 2020)
  • April 30, 2020 Public Meeting: NLM hosted a virtual public meeting to discuss the topics of interest identified in the Request for Information (RFI) on ClinicalTrials.gov Modernization and provide opportunities for virtual interaction and clarification of key topics. Presentations recorded from the initial session and two subsequent panels, as described in the meeting agenda (PDF; April 28, 2020), are provided below with running times and PDF handouts for each. A transcript of the entire meeting (PDF; May 28, 2020) is also available.
    • Introduction and Overview Session (55:21)

      Introduction and Overview Session Slides (PDF)

      (199.7MB)

      Summarizes ClinicalTrials.gov and its modernization effort, NLM's activities in response to the COVID-19 outbreak, and introduces members of the Public Service Working Group on ClinicalTrials.gov Modernization of the NLM Board of Regents; Provides an overview of the ClinicalTrials.gov modernization RFI and the most common themes from the 268 responses to the RFI questions. (May 28, 2020)

    • Information Submission Panel (50:57)

      Information Submission Panel slides (PDF)

      (179.3MB)

      Summarizes major themes from RFI comments addressing ways to improve information submission using the Protocol Registration and Results System (PRS) (Topic 2 in RFI) and features presentations from three panelists who highlight diverse perspectives on information submission. (May 28, 2020)

    • Website Functionality Panel (1:06:07)

      Website Functionality Panel slides (PDF)

      (232.4MB)

      Summarizes key trends in RFI responses on the functionality of the ClinicalTrials.gov website (Topic 1 in RFI) and provides case studies from four panelists on different ways in which the ClinicalTrials.gov website can be used. (May 28, 2020)

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This page last reviewed in January 2023