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In our June issue:

PEER-REVIEWED ARTICLES

Monoclonal Antibodies: PK Keys & Cues
Narine Baririan, PharmD
Monoclonal antibodies often exhibit pharmacokinetic/pharmacodynamic properties that are much more complex than those associated with small-molecule drugs. This report outlines the unique PK factors and peculiarities that are essential to consider when designing and executing early stage clinical trials for these products.
Patients as Research Partners
Lindsay Singler, Patty McAdams, Gina Uhlenbrauck, Kirk Jernigan, Julie Schulman
Amid the evolution of patient involvement in clinical research, as patients take more active roles in decision-making about clinical trials, authors present three different patient partnership models to help researchers evaluate which method of engagement could work best for them.
Optimizing Enrollment Cycle Times
Valerie Legagneur, Jonathan Peachey, Karen Correa, PhD, Gen Li, PhD
Clinical trial case study illustrates how one clinical study planning platform was used to aid researchers and facilitate communication with key stakeholders—and uncovers new learnings in the critical connection between site activation and patient enrollment cycle time.
NEWS

Washington Report: Jill Wechsler details the continued rise of incorporating the "patient experience" in drug development measures.

EU Report: Peter O'Donnell explores the convergence of policy and science in new vaccine R&D pursuits in Europe.

Q&A: Leader of one longtime CRO discusses the marked changes in clinical trial practice from past to present—and his company's unique focus.

CLINICAL TRIAL INSIGHTS

New-Paradigm Need, Opportunity
Ken Getz
Sobering statistics collected on clinical trial execution point to the eventual convergence of healthcare and clinical research operating environments.
CLOSING THOUGHT

The 'Rareness' of Cancer
Stephen Gately, PhD
With more common cancers now increasingly broken down by specific genomic defects, the future of research for any cancer is entirely, and unequivocally, molecular.
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issue:
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BLOGS
Establishing a Clinical Transparency Committee is Key to Managing Global Disclosure
Medical Monitoring Risk Exposure in New Regulatory Climate
Sponsors–Can You Answer 6 Questions Regulators Ask During Audits?
WEBCAST
Debunking the Myths of Risk-Based Monitoring
Learn why risk-based monitoring (RBM) is more than just source document verification and remote monitoring, and discover the tools companies need to fully implement RBM for quality management at every level.

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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