Brownley Kimberly A, Rape Marie, Wood Amanda, Dave Gaurav, Henderson Chad, Severynse-Stevens Diana, Zmuda Mike, Earp Diane, Moody Carmella, Kelly-Pumarol Issis, Andrews Joseph, Foss Kristen M, Fraser Stephanie, Segear Erika, Parrish Amanda B
North Carolina Translational & Clinical Sciences Institute, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Department of Psychiatry, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
J Clin Transl Sci. 2021 Jan 26;5(1):e82. doi: 10.1017/cts.2021.3.
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 6000+ 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.
在学术机构中，能够协助研究人员应对新药和器械开发监管流程的专业人才有限。我们创建了ReGARDD（药物和器械学术研究监管指南），这是一个区域性论坛，最初由来自四个获得临床与转化科学奖（CTSA）资助机构的监管专业人员参与，旨在积累和利用本地专业知识，并开发一个面向学术研究人员的监管指南网站。自2015年以来，成员们组织了15次论坛，涵盖了诸如美国食品药品监督管理局（FDA）上市前申报、基因治疗以及器械和治疗方法的知识产权等主题。通过用户反馈、针对性调查以及持续的迭代过程，我们完善并维护了一个共享的监管网站，该网站在2019年拥有超过6000名用户。网站更新改进了药物与器械主题领域的导航，提供了新的教育内容和视频以解答常见问题，并创建了一个发布即将到来的培训机会的门户。调查受访者对该网站给予了好评，并支持将ReGARDD扩展为一个集中资源。ReGARDD加强了区域监管人员队伍，提高了监管效率，并推广了最佳的组织和运营实践。在CTSA联盟中广泛部署ReGARDD模式可能有助于创建一个区域论坛网络，并减少在获得监管支持方面的差距。
