ClinicalTrials.gov Modernization

About
NLM Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization
Request for Information (RFI)
Events
Stay Informed

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 Musings from the Mezzanine blog: Celebrating 20 Years of ClinicalTrials.gov and Looking to the Future (January 7, 2020): Guest post describing a new opportunity to engage with us to enrich and modernize ClinicalTrials.gov.
NLM Musings from the Mezzanine blog: Engaging Users to Support the Modernization of ClinicalTrials.gov: (August 13, 2019): Guest post announcing NLM's modernization effort to make ClinicalTrials.gov an even more valuable resource with a renewed commitment to engage with and serve the people who rely on it.
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)
- Webinar slides (PDF)

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; April 28, 2020).

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.

Events

April 30, 2020 Pubic 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)