| FDA Launches Crowdsourcing Challenge: Pediatric Research Questions | | | The U.S. Food and Drug Administration (FDA) Division of Pediatrics and Maternal Health (DPMH) has launched the "Send Your Pediatric Research Questions to FDA" crowdsourcing challenge. DPMH is using this challenge to provide an opportunity for interested stakeholders to submit ideas for research using pooled analyses of pediatric clinical trial data directly to FDA's scientific staff. In recent years, FDA's scientists have published numerous pooled analyses that have advanced pediatric regulatory science. Pooled analyses have been used to deepen understanding of extrapolation of adult efficacy data, investigate relationships between biomarkers and different clinical endpoints used in regulatory submissions, and explore the use of innovative trial designs in small populations. However, DPMH wants to hear your ideas for research questions with potential to accelerate or inform pediatric drug development that can be addressed with pooled analysis. After this challenge ends, all submitted ideas will be reviewed, and DPMH may select one or more questions for possible future analyses by FDA staff. Please note that individuals who submit research questions will not obtain access to data or collaborate in any new research studies initiated by FDA. Submissions to this challenge must be received by August 20, 2021. Visit DPMH's Crowdsourcing site for more information about how to submit your research idea to the challenge and to see examples of ideas that may be considered. All submissions and discussions on the site will be moderated by FDA staff. If you have any additional questions about this challenge, please contact Lily Mulugeta at yeruk.mulugeta@fda.hhs.gov. | | | The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA. | | | |
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