In our October issue:
FEATURED
Drug-CDx Co-Development
Barry S. Sall, Angela X. Qu, MD, PhD
Sponsors are investing heavily in targeted medicines, many of which require a companion diagnostic test to predict likely responses. Authors present five steps to effectively navigate the complexities and challenges of drug-biomarker co-development.
Oversight Overhaul
Crissy MacDonald, PhD
The recently updated guideline for good clinical practice—ICH E6 (R2)—includes a major addendum on clinical trial monitoring. This report reviews the key changes and resulting challenges, and offers recommendations for compliance that companies can implement.
Improving Pediatric Clinical Trials
David Bowser, Martin A. Graham, PhD
Establishing needed momentum in the world of pediatric drug development will rely greatly on strategic alliances that bring together expertise to address efficient clinical trial design, regulatory compliance, and protections for younger patients.
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NEWS
Washington Report: Jill Wechsler on FDA efforts to streamline clinical trials for new antimicrobials.
EU Report: Peter O'Donnell questions the overlap of digital health and health technology assessment discussion strategies in the EU.
Clinical Outsourcing: Q&A highlights M&A movement toward mid-sized CROs focused in specific disease indications.
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CISCRP CORNER
The Full-View Value
CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger
The latest series of results from CISCRP's Perceptions & Insights Study shows how mapping patients' health journeys can drive a deeper understanding of their experiences and motivations.
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CLOSING THOUGHT
Market Landscaping Minefield
An Nguyen
Tips and resources to help avoid the common traps of market landscaping—today an increasingly high-stakes and comprehensive pre-approval task.
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