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T-38: So You Want to Redesign a Website Supporting a Complex, Global, Multi-Stakeholder Clinical Research Enterprise …Now What?

Poster Presenter

      Jui Shah

      • Regulatory Support Branch Chief
      • National Institutes of Health (NIH)
        United States


To share how a US Government Agency, sponsoring a global HIV/AIDS clinical trials portfolio, leveraged a CRO relationship to optimize communication strategies and knowledge sharing with stakeholders via a redesigned website, to promote regulatory compliance and successful clinical trial conduct.


Our successful website redesign process included: 1) identification of the Content Management System, 2) data analysis to examine the use of the existing website, 3) working group meetings with subject matter experts, and 4) in-person demonstrations to obtain stakeholder buy-in and feedback.


The Division of AIDS’ (DAIDS) clinical research enterprise includes many stakeholders (i.e., Clinical Research Sites and Networks, Data Management Centers, Pharma, etc.). Engagement with these stakeholders to identify issues and to document issue resolution has been critical to the success of DAIDS’ global clinical trials. To promote regulatory compliance and knowledge sharing, a Government-CRO relationship was leveraged to redesign a website used regularly by stakeholders. The DAIDS Regulatory Support Center (RSC), which is run by the CRO, and provides essential support in the proactive identification and resolution of stakeholder concerns, acted as subject matter experts (SMEs) for the website redesign project. The DAIDS RSC worked closely with DAIDS on the technical and content development aspects of the website redesign and applied project management principles to ensure best practices throughout the process. Design elements included: 1) selecting the Content Management System based on pre-defined needs, 2) organizing existing website material and resources based on target audience rather than contract task areas, 3) facilitating ease of access to commonly viewed documents and pages by limiting the number of clicks and by duplicating information across the site, and 4) implementing mobile accessibility to enhance the overall user experience. An internal working group at the DAIDS RSC was established for this project, to provide subject matter expertise and communicate with DAIDS. The DAIDS RSC provided demonstrations of the redesigned website to DAIDS and made updates based on feedback provided. All meetings and DAIDS approvals were documented carefully. Prior to release of the updated website, applicable trainings were conducted to facilitate user navigation and ensure effectiveness of the Content Management System. Varied outreach mechanisms were used to communicate the roll-out of the redesigned website before and at the time of the release.


The Government-CRO relationship has been an integral part of DAIDS’ efforts to implement more efficient processes and maximize the use of new technologies to advance HIV/AIDS clinical research (including >380 active protocols under >115 INDs) being performed by >365 DAIDS clinical research sites in ~25 countries around the world. The resources and tools made available via a redesigned public, mobile-accessible DAIDS RSC website have significantly contributed to effective communications, as well as optimized clinical research operations-related knowledge sharing across DAIDS, the DAIDS RSC, and DAIDS’ other stakeholders. In addition, the project management principles applied to the redesign of a website based on improved usability and access for the target audience have been crucial to promoting regulatory and procedural compliance, thereby facilitating the conduct of complex HIV/AIDS clinical trials across the globe. The success of the website redesign project shows how the Government can effectively leverage its CRO relationships to redesign a website to optimize timely communications and knowledge sharing to support critical clinical research in advancing the fight against HIV/AIDS in diverse regions around the world, including clinical trial sites in resource-limited settings. [This work was supported by DAIDS, NIAID NIH contract HHSN272201000013C].

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