Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Yi Huang (UMBC)
Nagaraj Neerchal (UMBC)
Bimal Sinha (UMBC)
Tze Lai (Stanford)
Phillip Lavori (Stanford)
Ying Lu (Stanford)
Jie Chen (Novartis)
Joseph Heyse (Merck)
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Thomas Fuerst from BioClinica, Inc..
Paper: Imaging Endpoints in Clinical Trials – Medical, Technical and Regulatory Considerations
The role of medical imaging in clinical trials has continued to expand in recent years as pharmaceutical and biotech companies look for more efficient and reliable means to evaluate new drug candidates. Imaging plays a role in patient selection as well as evaluation of safety and efficacy endpoint. However the successful use of imaging in multicenter clinical trials relies on a proper understanding of the technical capabilities and limitations of imaging methods, the association of imaging endpoints with clinical outcomes and their regulatory acceptance. In this talk we will review various factors to be considered when employing imaging endpoints in early and late phase trials.