In our April issue:
PEER-REVIEWED ARTICLES
Smart Clinical Program Designs
Mary Banach, Hon-Sum Ko, Steven Hirschfeld, Maria Benjegård, Ian Fisher, Mitra Rocca, Rashedul Hasan, Kerstin Forsberg, Dale Plummer, Courtland E. Yockey, Johann Proeve, Laszlo Vasko
Efforts to streamline clinical trial processes with automation and digitization
of data capture and reporting have failed to improve overall product approval rates or lower the cost of clinical research. Hence, authors present the Clinical Development Design (CDD) Framework, a learning-system model based on the principle that decision-making is dependent on and enhanced by "enabling information."
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(Natural) History Lessons in Rare Disease
Thomas Ogorka, Gajendra Chanchu
Conducting clinical trials in rare diseases continues to be challenging for several reasons, as gaps in the understanding of these conditions and their natural course of progression remain. The incorporation of natural history (NH) studies to support development programs for orphan drugs have become increasingly important in overcoming these challenges.
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NEWS
Washington Report: Jill Wechsler on the tug of war in accelerating orphan drug development.
EU Report: Peter O'Donnell looks at lingering uncertainties and legal challenges hanging over EMA's relocation.
Q&A: How one big pharma company is helping empower and educate patients on clinical trials and tighten connections with sites.
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CISCRP CORNER
Patient Feedback on HCP Engagement
CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger
The second series of results from the Center for Information and Study on Clinical Research Participation's (CISCRP) landmark 2017 Perceptions & Insights Study. |
CLOSING THOUGHT
Correcting Common eConsent Myths
Eric Delente
Debunking six myths associated with the electronic informed consent process in clinical trials.
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