In our September issue:
SURVEY SPOTLIGHT
Bridging Research and Clinical Care
Lisa Henderson
Results from new ACT and SCORR Marketing survey reveal telling insights on the challenges, activity level, and motives in advancing clinical research as a care option.
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FEATURED
Clinical Trials in a Dish
Kevin P. Coyne, Shawn T. Coyne, Bernard Fermini
A new process, known as Clinical Trials in a Dish (CTiD), offers the potential to remove future clinical failures much earlier in the process, resulting in significant improvements in R&D productivity.
Modeling & Simulation in Oncology
Julie Bullock, PharmD, Marc Pfister, MD, FCP
How the use of M&S in cancer trials from the outset can help address those critical "what if?" questions and facilitate development, approval, and cost justification of oncology drugs.
Genetic-Testing Considerations
Expert panel discusses the importance for sponsors in taking the right approach—ethically and in handling and disclosing data—when conducting gene-based screenings in clinical trials.
Challenging the ‘Site-First’ Standard
Tammy D'Lugin-Monroe, Daniel Brunwasser
Case study highlights a new patient-centric enrollment model that uses a data-driven approach to identify qualified patients first—and overcome traditional “site-first” limitations.
Future of mHealth: 3 Possibilities
Jonathan Palmer
With the rise of mHealth tech in clinical trials, the prospects for advancing practical benefits in drug development via the cloud are explored.
Pediatric Cancer Trials in SSA
Jonathan Palmer
A look at the need and opportunity for more childhood cancer-focused clinical studies in sub-Saharan Africa (SSA).
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NEWS
Washington Report: Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.
EU Report: Peter O’Donnell gauges the impact of FDA guidance on igniting the adaptive pathways debate in Europe.
Q&A: One nonprofit's efforts to raise the relevance of the clinical research enterprise.
Q&A: Partnership focuses on integrating research into the care continuum.
Patient Enrollment: Comparing five site-level models of the future in the quest to find the right patients—faster.
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CLINICAL TRIAL INSIGHTS
The Upfront-Planning Imperative
Ken Getz
The need to rethink traditional cycle-time reduction strategies is critical
for sponsors, CROs, and sites.
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CLOSING THOUGHT
Quality Keys for In-Home Trials
Eric Hayashi
Ensuring that complex, in-home studies deliver high-quality data requires addressing unique challenges in design and execution.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lisa.henderson@ubm.com
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