Dr. Joan Busner, Signant’s Clinical Vice President and in-house expert on pediatric and orphan disease clinical trials, recently co-authored three articles in Innovations in Clinical Neuroscience on the following topics:

• Special challenges in pediatric drug development related to cognitive and functional capacity assessment, recruitment and assessment of children for research and development of appropriate biomarkers for use in child populations, and rater training to address symptoms in pediatric populations.
• Implications of pediatric initiatives on CNS drug development for all ages as well as the current landscape of pediatric development programs, ethical implications, and global regulatory issues and challenges concerning pediatric clinical research.
• Patient centricity in the design and conduct of clinical trials in orphan diseases, including an overview of past mistakes that have plagued trials that did not consult with patient groups in the early design phase, an industry perspective of a recent trial that benefited from the inclusion of patient input, and regulatory perspectives of the United States (US) Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Dr. Joan Busner has over 35 years of experience as an academic psychiatric researcher and psychopharmacology principal investigator, and founded and directed two university psychiatric clinical trials units. She served continuously on University Institutional Review Boards for 20 years. At Signant, she has scientific and clinical responsibility for studies in mood, anxiety, pediatrics, and rare/orphan diseases. She has also overseen hundreds of trials and trained thousands of raters. Dr. Busner is currently Affiliate Associate Professor of Psychiatry at Virginia Commonwealth University.

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