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ORISE Fellowship Opportunity at the FDA: Use of Synthetic Control Arm

From: Mulugeta, Yeruk <Yeruk.Mulugeta>
Date: Mon, 31 Aug 2020 19:19:52 +0000

The Division of Pediatric and Maternal Health at the FDA in collaboration w=
ith the Oncology Center of Excellence is seeking a fellow who is interested=
 in working on a regulatory science project.


Single arm, uncontrolled studies are used in approximately 25% of pediatric=
 drug development programs and 63% of rare disease trials. Single arm trial=
s are often difficult to interpret. This project proposes that patient-leve=
l matching approaches like propensity scores can be used with historical cl=
inical trial data to create a synthetic control arm to improve context for =
the interpretation of single arm trials.

The participant will gain extensive knowledge on methodological approaches =
used with historical clinical trial data to create a synthetic control arm.=
 In addition, the participant will gain experience in review of methodologi=
cal features of studies, data curation and database building, data analysis=
, dissemination of results (presentations, publications), etc.
Opportunities are available for current students in a Ph.D. or other profes=
sional doctorate program and graduates with a doctoral degree in statistics=
, pharmacometrics, etc.

Interested applicants should apply directly using the link below:
https://www.zintellect.com/Opportunity/Details/FDA-CDER-2020-0556


Lily Mulugeta, PharmD
Yeruk.mulugeta

Associate Director, Policy and Research
Division of Pediatric and Maternal Health
Office of New Drugs, CDER, FDA


Received on Mon Aug 31 2020 - 15:19:52 EDT

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