In our December/January issue:
PEER-REVIEWED ARTICLES
Assessing Sagging Study Numbers in Central & Eastern Europe
Tomas Novak, Maxim Belotserkovsky, Ginny Payeur
Though statistics clearly show that the number of global clinical trials continues to rise, percentual substitution measures, however, reveal a gradual decline in studies in all Central and Eastern Europe EU countries. Authors explore whether this is a fluctuation or a trend.
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Swiss Strong: Country a Guiding Force in Trial Regulations
Mario E. Corrado
Switzerland, though small in stature, has taken on a large role in guiding innovation in clinical trials regulation in Europe since its introduction of an advanced legal framework in 2014. This article discusses the most relevant innovations of the new regulation and how Switzerland has already successfully benchmarked some of the same key principles of looming European clinical research law.
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Site Management Challenges in Eastern Europe
Nikolay Grechko, MD, Kateryna Bezditko, PharmD, PhD, Sergii Myronenko, MD
Despite advantages such as high recruitment rates, moderate costs, and motivated investigators, challenges remain for sponsors in managing clinical trial sites in Eastern Europe. Authors present the results of a comprehensive site-performance survey to better understand the regional-specific risks and challenges of conducting studies in Eastern Europe.
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NEWS
View From Washington: Jill Wechsler on the key R&D drivers for 2016: Patient voice, PDUFA negotiations, and pandemic treatment response.
View From Brussels: Peter O’Donnell reports on the troubled waters for orphan drug development and access in Europe.
Global Report: Philip Ward previews the DIA Annual EuroMeeting and the important global issues that will dominate discussion.
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CLINICAL TRIAL INSIGHTS
Patient Engagement: Illness-Level Impact
Ken Getz
Study uncovers the subtle distinctions in attitudes and perceptions between clinical trial patients with mild and severe illnesses. |
CLOSING THOUGHT
Clinical Trial Technology in 2025
Tina Siemens
The three key technology advancements poised to reshape global studies over the next 10 years. |
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