ClinicalTrials.gov Modernization Effort: Beta Releases Now Available

Guest post by Anna M. Fine, PharmD, MS, acting director of ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health.

Earlier this year, we provided an update on NLM’s efforts to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. NLM released a request for information, hosted public webinars, and adopted a user-centered design approach intended to help ensure that modernization is responsive to user needs.

These activities, together with input from the NLM Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization, supported the development of beta versions of a new ClinicalTrials.gov website and components of the information submission system, also known as the Protocol Registration and Results System (PRS). The beta releases feature a modern look and feel and provide updated technology to support users.

NLM is pleased to announce the public availability of these beta releases, which present the first of many new features to come.

ClinicalTrials.gov Website and PRS Goals and Implementation
The goals of the beta releases of the ClinicalTrials.gov website and components of the PRS are to:

• Introduce users to the new technology platforms and evaluate their real-world performance,
• Provide foundational features that will be expanded over time,
• Provide PRS users with improved functionality to manage their record portfolios and workflows, and
• Collect user input to inform future development activities.

The beta sites will function in parallel to the current systems to allow for usability testing and iterative improvements and to enable features and functions to be added without disrupting the current user experience. Users will gradually be transitioned to the new sites, or site components, as they are completed. Communication about changes and their related timelines will occur early and often to allow an easy transition to the new user experience.

Highlights of the Beta PRS Release
Study sponsors and investigators play a critical role in providing the information that makes ClinicalTrials.gov useful to data researchers, patients and their advocates, and the broader public. To better support the individuals who provide this information via the PRS, the modernization effort will make the submission of high-quality study information more intuitive, which in turn, will also benefit the end users of the data. These changes are intended to help PRS users meet existing reporting requirements; they do not alter those requirements.

The first beta PRS release will be available early 2022 and focuses on new workflow and portfolio management features such as customizable display and multiple download options to help data submitters save time. A recorded demonstration highlighting the features of the upcoming release is now available.

Highlights of the Beta ClinicalTrials.gov Release
The modernization effort has implemented a responsive site design that better supports mobile device users and added information written in plain language. The current release focuses on basic features, with more features to be added over time based on user feedback.

The first beta ClinicalTrials.gov release includes:

• Redesigned home page and search feature,
• Search results page with updated filter functionality,
• New study record design with improved record navigation and study location information displayed using a web-based mapping application, and
• Informational content presented in plain language such as Background and Learn About Studies webpages.

Again, this release is foundational, and more features will be added in the future. Importantly, we are developing advanced features to better meet the needs of data researchers and similar users, who use clinical trial information in their work.

Measuring Success, Next Steps, and Future Releases
User feedback received from website surveys, analytics, and continued engagement will help us assess the success of the first beta releases. Following validation of the technology’s performance and implementation of revisions made in response to user feedback, subsequent releases will address additional priorities identified by our user engagement efforts that are expected to help meet other patient and data researcher needs. Specific details of each component and release will be communicated to stakeholders as information becomes available.

For more information about activities and achievements during the modernization effort’s first two years, see the September 2021 NLM report summarizing the progress through August 2021, or view the October 2021 webinar for an update on the latest progress. To learn about related events and upcoming site enhancements and features, visit the ClinicalTrials.gov Modernization webpage. We appreciate your support as we seek to improve the features and functionality of this critical NLM resource. If you would like to receive email updates, I encourage you to sign up for Hot Off the PRS.