Guest post by Rebecca Williams, PharmD, MPH, acting director of ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. Originally released on the Musings from the Mezzanine blog.
In 2019, NLM introduced a multi-year effort to modernize ClinicalTrials.gov, the world’s largest publicly accessible database of privately and publicly funded clinical trials. This effort was launched with a commitment to engage with and serve the millions of users who rely on this essential resource — with a focus on delivering an improved user experience on an updated platform that will accommodate growth and enhance efficiency.
In keeping with that promise, NLM has embarked on several stakeholder activities as part of the roadmap for modernization that we want to highlight in this post. We will also continue to share opportunities for involvement and invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET (watch the recorded webinar) to learn more about our modernization efforts.
Early in the process, our modernization team reached out to stakeholders through a request for information (RFI) to solicit input on topics around website functionality, information submission processes, and use of data standards. We received nearly 270 responses, which were summarized and discussed during a virtual interactive public meeting held in April 2020, and attended by nearly 400 participants. This robust feedback from the stakeholder community, along with input gathered from leaders and stakeholders across the NIH, provided the foundation to identify high-impact user-driven goals and set priorities. Currently, to advance the crucial next step of setting modernization goals and priorities, the team is working closely with NLM’s Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization. Members in this group represent a range of stakeholder perspectives and provide input to ensure the continued integrity and utility of ClinicalTrials.gov.
Feedback received in response to last year’s RFI revealed several themes for modernizing ClinicalTrials.gov including ways to improve the management of search results, study records, and plain language information for the website, as well as enhancements to support structured and unstructured data, the quality control review process, and workflow management for information submission.
Three key external stakeholder groups were identified and consist of diverse individuals that share common interests and goals, but also have unique circumstances and needs. Feedback received from our engagement efforts, as well as the working group, reinforce the importance of being able to serve all stakeholders, including:
- Data providers, who are responsible for submitting, updating, and managing clinical trial registration and results information through the ClinicalTrials.gov submission system, also known as the Protocol Registration and Results System (PRS). The clinical trial information provided by this stakeholder group is listed on ClinicalTrials.gov for use by others.
2.Patients and their advocates, who find and use information about clinical trials for themselves or others through ClinicalTrials.gov.
3. Data researchers, who use clinical trial information to study the clinical research enterprise, such as detecting trends in research and gaps in medical knowledge, identifying trials for use in systematic reviews and meta-analyses, and validating reported outcome measures and study design through ClinicalTrials.gov or its application programming interface, or API.
We aim to ensure that:
- Clinical trial information is current, complete, and reliable.
- All users can easily find and use information about clinical trials.
- Clinical trial information, resources, and tools provide value to the research ecosystem.
NLM is employing a user-centered design approach to modernization. This includes user feedback loops and prototypes to elicit user input on new features in an iterative manner. A new version of the ClinicalTrials.gov website will be released first, in parallel to the current website, to obtain maximum user input. Work on the website began with extensive planning and research and has since shifted into implementation that includes building the technical foundation in a cloud-based platform; designing key elements for the homepage, search results, and study records; and testing approaches for the continuous improvement of search results. We expect to release the new website for broad user testing by Fall 2021. Work related to the PRS is in the planning and research stage, with prototype development underway.
As ClinicalTrials.gov and the PRS undergo “construction,” be assured that one of the core principles guiding NLM’s ClinicalTrials.gov modernization effort is to minimize disruption to our users while continuing to deliver improved services to maximize the value of this resource to the people who rely on it.
We are also developing continuity approaches for the PRS, management portal, and website to ensure a smooth transition to updated features. We will continue to provide stakeholders with updates and a timeline of activities as they become available.
Stay Informed and Involved
NLM is committed to keeping you informed throughout this modernization effort. We invite you to join us for an upcoming webinar on February 18, 2021 at 3 pm ET where you will receive additional updates on our modernization efforts and learn about future opportunities for you and your communities to be involved. To register, please visit the ClinicalTrials.gov webinar registration page.
Watch the recorded webinar here (transcript available).