Engaging Users to Support the Modernization of ClinicalTrials.gov

Guest post by Rebecca Williams, PharmD, MPH, acting director of ClinicalTrials.gov at the National Library of Medicine, National Institutes of Health. ClinicalTrials.gov is the largest public clinical research registry and results database in the world – providing patients, health care providers, and researchers with information on more than 300,000 clinical studies of a wide range of diseases and conditions. More than 145,000 unique visitors use the public website daily to find and learn about clinical studies, resulting in an average of 215 million pageviews each month. Recognizing the value of ClinicalTrials.gov to millions of users, the Board of Regents of the National Library of Medicine (NLM) described in the 2017-2027 strategic plan the importance of ensuring the long-term sustainability of this resource. NLM is committed to this goal and aims to modernize ClinicalTrials.gov to deliver a modern user experience on a flexible, extensible, scalable, and sustainable platform that will accommodate growth and enhance efficiency. We are undertaking this 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. These users include the sponsors and investigators who submit clinical trial information for inclusion on the site through the submission portal. They also include patients, health care providers, and researchers who access listed information on ClinicalTrials.gov, whether directly or indirectly through other sites and services that use the ClinicalTrials.gov application programming interface. Over the past several years, we have conducted testing with users and have already made some improvements in response to this feedback. With modernization, we will continue to support key functions identified by users of ClinicalTrials.gov while also seeking ways to make it an even more valuable resource. To continue the modernization process, we are now seeking broader engagement with users to further help us determine how to evolve ClinicalTrials.gov. We are spending this summer looking inward by engaging our fellow National Institutes of Health Institutes and Centers to understand how ClinicalTrials.gov could better help in fulfilling NIH’s goals of clinical trial stewardship and transparency. This fall, we plan to expand our reach outward and are proposing to establish a working group of the NLM Board of Regents to focus on the modernization of ClinicalTrials.gov. This working group will provide a transparent forum for communicating and receiving input about efforts to enrich and modernize ClinicalTrials.gov. We want to ensure that we understand and consider changing needs while simultaneously maximizing the value of the growing amount of available information and preserving the integrity of ClinicalTrials.gov as a trusted resource. We’ve already taken some steps to be more proactive in communicating with our users. We just launched “Hot Off the PRS!” (sign up to receive email announcements), a new informational bulletin for users of the ClinicalTrials.gov Protocol Registration and Results System (PRS). These updates provide timely announcements about new PRS features, relevant regulations (42 CFR Part 11) and policies, and information about other offerings such as the PRS Guided Tutorials (BETA), a new training resource with step-by-step instructions for submitting results information. We’re excited about how greater user engagement will enrich and modernize ClinicalTrials.gov, improving its value for everyone throughout the clinical research lifecycle. Please let us know what else we can do to make ClinicalTrials.gov the best it can be.