Washington DC, December 9, 2019 – The Forum for Collaborative Research announced the publication of a manuscript, "Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease" in the December 2019 issue of the peer-reviewed journal Gastroenterology.
Nonalcoholic fatty liver disease (NAFLD), often associated with overweight and obesity, is the most common chronic liver disease in the United States and other developed nations. This condition, when accompanied by inflammation and cell injury, can lead to devastating consequences to the liver and other organs.
"Almost 10% of all children in the United States, and 38% of obese adolescents are affected by NAFLD," said Veronica Miller, PhD, Executive Director of the Forum for Collaborative Research. "Learning how pharmacological treatment can complement life-style modification to change the natural course of disease from childhood through adolescence and into adulthood is of urgent importance."
The manuscript was developed by members of the Liver Forum's working group on pediatric issues, and was led by Miriam B. Vos, MD, MSPH, Emory University School of Medicine and Joel E. Lavine, MD, PhD, Columbia University Medical Center.
"With no approved drug therapies yet available in adults or children, it is imperative that regulatory agencies, pharmaceutical developers, and academicians come to agreement about the appropriate targets for therapy, and methodologies to assess response and outcomes for pediatric clinical trials," said Lavine. "The Liver Forum brought together all concerned stakeholders in drug development, research design, and regulatory science to develop consensus on these matters."
Clinical trials in pediatric populations pose different challenges than trials in adult populations and require different regulatory considerations. This review and associated recommendations have been developed as a resource to facilitate the development and conduct of clinical trials in pediatric populations.
"The availability of appropriate therapies for children and adolescents should not be unnecessarily delayed," Miller said. "The Liver Forum offers an opportunity to tackle this problem in real time as we learn more of how emerging treatments are behaving in adults."
The Liver Forum is a project of the Forum for Collaborative Research. The article is available online at: https://authors.elsevier.com/a/1a6C03mEmRtM7.
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About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the UC Berkeley School of Public Health is a public/private partnership with a mission to catalyze clinical development and improve global health by facilitating research, informing policy, and advancing regulatory science. The Forum's three-pronged approach (practice, research, education) accelerates safe drug development by increasing clarity, cooperation and innovation, while maintaining standards of evidence. Forum members work in clinical practice, research, academia, industry, regulatory authorities, and patient advocacy. Using proven models for stakeholder engagement they enhance clinical trial efficiency, support fair participation, and expand access programs. Current projects focus on cytomegalovirus (CMV), viral hepatitis B (HBV), human immunodeficiency virus (HIV), nonalcoholic fatty liver disease (NAFLD)/ nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and rare diseases.
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References
1. Schwimmer JB, Deutsch R, Kahen T, et al. Prevalence of fatty liver in children and adolescents. Pediatrics 2006;118:1388-1393.
2. Welsh JA, Karpen S, Vos MB. Increasing prevalence of nonalcoholic fatty liver disease among United States adolescents, 1988-1994 to 2007-2010. J Pediatr 2013;162:496-500