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S055-2

Roles of Clinical Research Organization in Advancing Psychiatric New Drug
Development

Chaucer Chiao-Hsiang Lin

Therapeutic Areas Head in JAPAC, Global Therapeutic Area Lead for CNS, Taiwan

Background/Objective: The costs of drug development tremendously increased in the past decade,
driving pharmaceutical companies to look for innovations and smarter ways for doing their R&D.
One of the major trends is to outsource their clinical research activities to Clinical Operation
Organization (CRO) as functional services provider but also strategic alliance. Developments of
psychiatric new drug are also in the same trend.

Method: Related publications, regulatory guidelines and industry experiences regarding roles of
CROs in the advances of new drug development with example of that for neuroscience were
reviewed and to be presented.

Result: To develop a psychiatric new drug, unmet medical need, use of placebos, drug-drug
interactions, implementation of rating scales and relevant social, cultural and regulatory differences
between geographic regions have to be considered in designing and executing clinical trials to obtain
data showing meaningful clinical advantage over existing standard-of-care treatments to gain
regulatory approval and achieve commercial success. Clinical programs for psychiatric indications
tend to be larger, longer, and more complex than those for others, resulting in, among other things,
the need for greater patient enrollment in clinical studies. Patient recruitment and retention, however,
are major bottlenecks in drug development programs, often leading to significant delays in study
initiation and higher trial costs. Experiences of CROs were approved to be a potential effective
solution.

Conclusion: Adaptions of innovative design, monitoring and imaging advances are especially
important in the alliance of psychiatric new drug sponsors and CROs.

Reference: 1. Deconstructing the Drug Development Process: The New Face of Innovation. KI
Kaitin. Clin Pharmacol Ther. 2010 March ; 87(3): 356–361. doi:10.1038/clpt.2009.293.
The Role of Contract Research Organizations (CROs) in Imaging for the Drug Development Process.
Izaak den Daas, Thijs van Iersel, and Johan Wemer (2012) The Role of Contract Research
Organizations (CROs) in Imaging for the Drug Development Process. Trends