MORRISVILLE, NC, NOV. 28, 2016 – Worldwide Clinical Trials (www.worldwide.com) will present a webinar, titled “Necessity is the Mother of Invention: The Impetus for Observational Research in Orphan Drug Development,” on Wednesday, December. 7, 2016 at 11 a.m. ET. Worldwide’s Chief Medical and Scientific Officer, Michael Murphy, M.D., Ph.D., will lead the discussion on emerging trends in clinical trial methodology for orphan disease drug development.
The presenters will address the increasingly diverse challenges associated with the clinical evaluation of orphan disease products, and the opportunities provided through observational research techniques. The discussion will explore the impetus for innovation from the perspective of different stakeholders, and highlight methods of data acquisition, analyses and presentation within observational research, which may inform both regulatory and healthcare decisions.
“One of the major challenges for rare disease clinical research is that increasingly innovative products are evaluated within limited patient populations with refined phenotypes and significant unmet needs. In this setting, traditional methods of program design may be ill-suited in scope and timing to address the spectrum of questions defining clinical utility as well as product value,” said Dr. Murphy. “During this webinar we’ll examine the impetus for innovation and the impact of observational research techniques as companion initiatives informing patient access.”
Dr. Murphy will be joined by several of his Worldwide colleagues who will bring their expertise to the discussion, including Josie Measures, Vice President of Biostatistical Operations; Lorna Graham, Associate Director, Project Management, Evidence; and Barbara Zupancic, Director, Global Patient Recruitment and Retention.
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About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-in-human through phase IV studies. Grounded in medicine and science, we help sponsors move from medical discovery into clinical development and commercialization across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID), and rare diseases. For more information, visit www.Worldwide.com.