Modernizing ClinicalTrials.gov for patients, health care providers, and researchers

The National Institute of Health’s (NIH) National Library of Medicine (NLM) manages ClinicalTrials.gov—the world’s largest public clinical research registry and results database, providing access to information on a wide range of human clinical trials. They also manage the Protocol Registration and Results System (PRS), a data submission portal searchable via ClinicalTrials.gov, with clinical trial information inputs directly from researchers.

In 2019, ICF began supporting NLM in modernizing both the ClinicalTrials.gov public website and the Protocol Registration and Results System. Part of the National Center for Biotechnology Information (NCBI), these sites receive more than 4.5 million monthly visitors, including patients, caregivers, health care providers, researchers, and trial sponsors.

Challenge

The legacy ClinicalTrials.gov and PRS applications launched in 2000. They ran on outdated technology with restricted scalability. Both applications needed to be rebuilt to reflect modern web development and responsiveness standards to ensure they could sustainably serve both the clinical research community and its wide range of users into the future.

Our objectives for the project were to:

• Modernize both applications using cloud-native technology and engineering best practices
• Provide a seamless user experience, using human-centered design (HCD) to better understand underserved communities and avoid unintended negative effects
• Reduce burden on data submitters and reviewers by improving workflows and incorporating artificial intelligence (AI) to reduce backlogs

Solution

Our multidisciplinary team included staff representing user research and design, engineering, content and subject-matter experts, and product and delivery. Together they used methodologies from HCD, product management, and Agile development to modernize and transform the legacy applications. We focused on modernizing one module at a time and released new versions of the applications alongside the legacy versions, phasing out the old ones over time to create a smoother user transition.

Modernizing digital experience to serve users with different needs: We wanted to make sure we deeply understood users’ needs and pain points. To make it happen, our teams:

• Recruited a wide variety of participants for our user research and testing pools
• Conducted 70 interviews with data submitters, data researchers, and patients
• Held 150+ moderated and unmoderated sessions with PRS and ClinicalTrials.gov users
• Reviewed thousands of user comments
• Followed USWDS design and 508 accessibility standards

Modernizing technology and infrastructure: Our engineering team used cutting-edge technology to build applications that are modular, secure, simple to maintain, and well-documented. We deployed with automated CI/CD pipelines and, to enhance scalability and availability even more, are now preparing to migrate to Google Cloud Platform.

Managing complex stakeholder relationships: This project called for partnership and clear communication in a multi-vendor environment. Our teams helped build understanding and collaboration between the ClinicalTrials.gov team and the NCBI technology teams, partnered closely with the ClinicalTrials.gov team to deliver executive-level briefings about the project to leaders across the NIH, and are working with NCBI’s DevOps team to continually monitor performance and resource usage.

Results

The modernized ClinicalTrials.gov public website became the primary site in June 2023. We worked to clarify the purpose of the site, added more plain language, improved search, implemented an overall design that makes clinical study pages easier to read, and optimized for mobile device experience.

The modernized PRS will be the primary website for protocol registration in late summer 2024. In developing the modernized PRS site, our team simplified navigation and data entry screens and included usage guidance. We’re now partnering with NCBI to streamline the reviewer experience with AI.

Feedback from users and ClinicalTrials.gov leaders has been overwhelmingly positive. “Usually you leave [a] feedback and you never get a response,” wrote one beta site user. “[The team’s responsiveness] makes you feel more connected, kind of feel more loyal to the system.”

Our microservices architecture and developer-friendly approach enabled our team to internally scale with the project, growing from a small Agile team to multiple teams working in close coordination quickly while maintaining high standards. We were able to seamlessly integrate the modernization work with the help of our industry experts who were intimately familiar with the program and CTG applications thanks to their previous work with NLM and ClinicalTrials.gov data collection. We’re proud that the wide variety of experts directly led to the project’s resounding success.