In our April/May issue:
PEER-REVIEWED ARTICLES
Biosimulation Blueprint: Pediatric Studies
J.F. Marier, PhD, Trevor N. Johnson, PhD, Suzanne Minton, PhD
Almost half of pediatric clinical trials conducted in recent years have failed to demonstrate either safety or efficacy, due in part to logistical and ethical challenges. With the support of two case studies, authors examine how a biosimulation approach in pediatric trials can help optimize study design and inform drug labels for safer dosing and response.
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Mastering Immunotherapy Trials
Chris Smyth, PhD
While the emergence of personalized therapies in the innovative immuno-oncology space has generated significant attention and promise, the complexities of immunotherapy trials present unique challenges for smaller-sized drug developers. This article explores five challenges smaller biopharmaceutical companies should prepare for when embarking on immunotherapy studies.
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Performance Boost: Value-Based Design
Frederic L. Sax, MD, Marla Curran, DrPH, Sarah Athey, Christoph Schnorr, MD, Martin Gouldstone
Integrating evidence-based planning and real-world evidence has the potential to reap big gains in clinical trial productivity. To achieve this, authors propose a "Three-Pillar" approach emphasizing knowledge sharing, evidence needs, and scenario risk-building.
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Targeted Drugs: Early Phase Guide
Karen Ivester
The need for rigorous clinical evaluation of newer targeted therapies—including highly sensitive immunotherapy combinations—is critical if these products are to produce successful outcomes in patients. This analysis outlines the important questions to consider in early phase protocol development for such trials and the key functional tools and approaches to apply in this setting.
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NEWS
View From Washington: Jill Wechsler on the new FDA commissioner’s push to refine clinical trial design and statistical methods through information technology.
View From Brussels: Peter O’Donnell reports on the new policy in Europe that may finally calm the debate around clinical trial data disclosure.
Global Report: Philip Ward examines the EMA’s new comprehensive guidance on oncology clinical development.
Data Analysis: Statistics reveal a telling trend in country involvement in Phase III trials and relationship to study duration.
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CLINICAL TRIAL INSIGHTS
Easing Protocol-Amendment Strain
Ken Getz
Sponsors and CROs are rallying to reduce the number of avoidable protocol amendments and ultimately improve protocol quality, executional feasibility, and efficiency. |
CLOSING THOUGHT
Precision Medicine’s Promise
Steve Rosenberg
The true potential of precision medicine efforts, such as the White House’s Cancer MoonShot program, will hinge on adhering to several key technology elements. |
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