Tuesday, May 18, 2021

FDA Launches Crowdsourcing Challenge - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data

Today, the U.S. Food and Drug Administration's (FDA) Oncology Center of Excellence (OCE) launched the "Send Your Oncology Research Questions to FDA" crowdsourcing challenge. OCE is using this challenge to provide an opportunity for interested stakeholders to submit ideas for research using pooled analyses of oncologic clinical trial data directly to FDA's scientific staff.

Traditionally, FDA's scientists have used pooled analyses to deepen understanding of efficacy of approved drugs, investigate relationships between different clinical endpoints used in regulatory submissions, and explore the potential for external controls to provide context for single arm trials. However, OCE wants to hear the questions you would like addressed with pooled analysis.

After this challenge ends, OCE may select questions for possible future analyses by FDA staff. If your research question is selected for further analysis, you will be recognized on the OCE website and social media, invited to a discussion with OCE leadership and honored at a virtual award ceremony.

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 June 4, 2021. Visit OCE's Crowdsourcing site for more information about how to submit your research idea to the challenge and examples of ideas that may be considered. All submissions and discussions on the site will be moderated by FDA staff.


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