Regulatory Webinar Series
So Many Procedures, So Little Time - How to Develop an Effective Schedule of Events for a Research Protocol. Presented by: Mike Fusakio, PhD; Nathan Hawk, BSPS; Samantha Sonoda, MS, CCRA; Lisa M. Tully, MA, CCRP, all affiliated with Cincinnati Children's Hospital Medical Center. Originally aired Dec. 2, 2020.
Single Institutional Review Board (IRB): Presentation & Panel Discussion. Features Nichelle Cobb, PhD, Smart IRB Director at University of Wisconsin-Madison. Panelists include James Cnota MD (Cincinnati Children's), Jeremy Corsmo, MPH (Cincinnati Children's), Pooja Khatri, MD, MSC (University of Cincinnati) and Mike Linke, PhD (University of Cincinnati). Originally aired Sept. 16, 2020.
Helpful Tips and Tricks for Developing and Amending Protocols for the Rare Disease Clinical Research Network, presented By: Mike Fusakio PhD, Cincinnati Children's Hospital Medical Center. Originally aired June 30, 2020.
For Early Career Researchers
NIH Mentored Research (K) Career Development Awards for Clinician Researchers, featuring Paula Gregory, PhD, Associate Dean for Faculty & Educational Development, UNTHSC Graduate School of Biomedical Sciences, with Debra Regier, MD, PHD, of Children's National Hospital, Principal Investigator of the Rare Disease Scholar's Program.
Diversity in Rare Disease Research
Reviews the limitations of classifying research participants by race, and recommends a series of steps for authors, researchers and policymakers to consider.
The U.S. Food and Drug Administration has published guidance on “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.” This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.
A central portal for NIH sharing policies that offers resources to help address common questions, such as which NIH sharing policies apply to a particular research project, how to share and submit data, how to access data from NIH-supported repositories, and more.
A collaborative initiative within the Clinical and Translational Science Awards (CTSA) Program that aims to execute clinical trials better, faster, and more cost-efficiently but, importantly, to be a national laboratory to study, understand, and innovate the process of conducting clinical trials.
A central resource-sharing platform where recruitment and retention resources developed by CTSAs and reputable community health partners are provided as a free resource to the research community.
The The NIH has released a Data Management and Sharing policy, which goes into effect January 25, 2023 and replaces the existing 2003 NIH Data Sharing Policy. The policy is updated to keep pace with scientific and technological advancements and emphasizes the NIH’s commitment to data management and sharing, which is seen as an integral piece to the conduct of research. A summary of the new policy can be found here.
Academic investigators, patient groups, and small or emerging pharmaceutical and biotechnology companies play a critical role in rare disease drug development and are often the sponsors for rare disease drug development, but they may lack regulatory experience. These resources will help bridge the gap between academic investigation and the regulatory aspects of drug development.