IQ DILI Initative Pediatric Working Group Open Call for Non-member Pediatric Hepatology Experts
Will Treem, Takeda - Chair
Background and Rationale
There is scant data available on DILI in the pediatric age group, especially when it occurs in the context of clinical trials for new drug development. Expertise in this area resides in pediatric hepatologists, particularly in those experienced in conducting rigorous clinical trials, with carefully monitored safety assessments, and formal causality assessments to pinpoint whether DILI is playing a role. This combination of attributes, experience, and knowledge would best be served by a pediatric hepatologist with both clinical/academic experience and industry pharmaceutical company experience in research and development and clinical trials in the pediatric population.
The Pediatric DILI working group in the IQ-DILI affiliate is tasked with surveying and reporting on current knowledge about DILI occurring in clinical trials in children, identifying gaps in our current knowledge of best practices for monitoring for, identifying, and managing DILI in these trials, and in designing data sharing projects or other methods of addressing those gaps. A non-member participant with the necessary background, skills, and experience would be an invaluable addition to our industry clinicians because of his/her focus on pediatric liver disease and knowledge of DILI in the pediatric age groups. Having a background in registration grade clinical trials for new drug approval would allow a clear understanding of the requirements and constraints in clinical trials that are germane to obtaining adequate information to adjudicate potential pediatric DILI cases.
Qualifications (all are necessary)
- Training and clinical experience in pediatric hepatology
- Participation during academic career in interventional clinical trials in children
- Experience with acute, chronic and progressive liver disease in children that might be confounders in potential cases of DILI
- Experience in pharmaceutical industry doing registration grade clinical trials for new drugs in adults and children with experience in monitoring for, diagnosing, and managing potential DILI during these clinical trials.
Respondents please note this is a volunteer role.
Please click here to send your response, including a current CV, by WEDNESDAY 4 MARCH.
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