ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices): The evolution of a collaborative regional CTSA-funded forum and website for regulatory support

Abstract

Availability of trained professionals to assist researchers navigating regulatory pathways for new drug and device development is limited within academic institutions. We created ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices), a regional forum initially involving regulatory professionals from four Clinical and Translational Science Award (CTSA)-funded institutions, to build and capitalize on local expertise and to develop a regulatory guidance website geared toward academic researchers. Since 2015, members organized 15 forums covering topics such as FDA premarket submissions, gene therapy, and intellectual property for devices and therapeutics. Through user feedback, targeted surveys, and ongoing iterative processes, we refined and maintained a shared regulatory website, which reached 6000þ users in 2019. Website updates improved navigation to drug versus device topic areas, provided new educational content and videos to address commonly asked questions, and created a portal for posting upcoming training opportunities. Survey respondents rated the website favorably and endorsed expanding ReGARDD as a centralized resource. ReGARDD strengthened the regional regulatory workforce, increased regulatory efficiency, and promulgated best organizational and operational practices. Broad-scale deployment of the ReGARDD model across the CTSA consortium may facilitate the creation of a network of regional forums and reduce gaps in access to regulatory support.

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe

“…It helps academic researchers prepare and submit regulatory applications to the FDA, develop and write clinical protocols, and keep pace with changing federal regulations. 11 Importantly, documentation and guidelines provided by the regulatory authorities need to be regularly updated to keep pace with emerging technologies and new methods of assessment. 12 Generally, EMA services were less known among academics than NCA services.…”

“…The platform is publicly available and provides up‐to‐date information to support best practice across the regulatory landscape. It helps academic researchers prepare and submit regulatory applications to the FDA, develop and write clinical protocols, and keep pace with changing federal regulations 11 . Importantly, documentation and guidelines provided by the regulatory authorities need to be regularly updated to keep pace with emerging technologies and new methods of assessment 12 …”

“…Furthermore, implementation of a low‐threshold contact point with NCAs, such as the informal consultations that some agencies already offer, could help to accelerate the processes and provide earlier signals of potential difficulties in projects. One option could be the creation of an interactive platform for academics to navigate through the regulatory requirements and timelines, similar to the ReGARDD platform 11 . The STARS project has run a pilot in which a one‐stop‐shop communication platform for Spanish academics was used to stimulate quick and informal communication between regulators and academic researchers.…”

“…One option could be the creation of an interactive platform for academics to navigate through the regulatory requirements and timelines, similar to the ReGARDD platform. 11 The STARS project has run a pilot in which a one‐stop‐shop communication platform for Spanish academics was used to stimulate quick and informal communication between regulators and academic researchers. The platform provided not only useful regulatory information, links, and documents, but also an opportunity to ask questions of the regulators free of charge.…”