In our October/November issue:
PEER-REVIEWED ARTICLES
Performance Review: Supply Logistics
Mary Jo Lamberti, Richard Hsia, Cheryl Mahon, Christine Milligan, Ken Getz
Despite increasing pressure on the clinical supply chain function, there is little-to-no historical data characterizing performance, measuring the impact of new processes, and identifying areas of improvement. To that end, through gathering of survey and study performance data, authors present comprehensive metrics on current supply management and distribution practices.
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Protecting the ‘Blind’
Leon Wyszkowski, Steven Yoder, Susan Diehl
The concept of “blinding” in clinical trials may appear simple, but in reality there are many practical considerations that add difficulty and can threaten the integrity of a study. This paper identifies six ways that supply chain professionals can help protect the blind in today's evolving R&D environment.
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Biologics: Sample Management Musts
Eric Hayashi
With biological samples today considered more valuable than in years past—as potentially vital keys to new branches of research—the critical components in sample management systems are examined, ranging from simple testing and storage to more complex sample methods and requirements.
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Ops Plan for Biosimilars
Hazel Gorham, PhD, Rodeina Challand
The operational challenges in developing a biosimilar are unique compared to new chemical entities, due to specific regulatory requirements for demonstrating similarity and still-limited understanding of the concept of biosimilarity among physicians and patients. Authors explore these challenges and how they can be addressed from the outset with strategic planning.
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NEWS
View From Washington: Jill Wechsler details the key revisions on the docket for PDUFA, which Congress still must consider amid looming administration change.
View From Brussels: Peter O’Donnell reports on efforts in Europe to gain consensus on the role health technology assessment should play in clinical trials.
Global Report: Philip Ward looks at the discussion heating up in Europe around the implementation of the Clinical Trials Regulation.
Data Analysis: Survey identifies the preferred methods of sponsors, CROs, and sites in conducting study feasibility analysis.
Regulatory: FDA guidance recommends the use of the first patient-reported outcomes-related measure in trials for COPD.
Patient Engagement: Q&A on the emergence of community-based studies—and the key supply management considerations involved.
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CLINICAL TRIAL INSIGHTS
Milestone for KPI Adoption
Ken Getz
Study finds that the majority of biopharma companies are finally using a standard set of senior-management level key performance indicators (KPIs). |
CLOSING THOUGHT
Cell Therapy: Plan Cold Chain Early
Tamie Joeckel
With multistep supply chains for cellular therapies and complex track and trace, logistics management systems can be useful even in the protocol-planning stage. |
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