In our October/November issue:
PEER-REVIEWED ARTICLES
Gene Transfer Studies: What You Should Know
Chris Jenkins, PhD, Lindsay McNair, MD
Amid steady activity among sponsors and CROs in the design and conduct of human gene transfer trials, this article explores the key challenges and strategies for these types of studies. Areas of focus include regulatory oversight, safety monitoring, informed consent, site selection, risk assessment, and endpoint selection.
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Therapy Masking: The True Measure
Barbara A. Ricker, Katherine M. Seymour, Alexander R. Arslan, April Slee, Ruth McBride, Jeffrey L. Probstfield, MD
Through results of the AIM-HIGH double-blind clinical trial, authors present evidence supporting the importance of assessing therapy-masking success in all instances, and to better gauge those effects soon after randomization in specific studies.
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Death Waivers Fall Short
Margarita Mare, MD, Lisa Carlson, Maxim Belotserkovskiy, MD, Nickolai Usachev, MD
Clinical trial experts argue that reporting of disease-related mortality as single events provides an incomplete picture of drug safety. Alternatively, to better ensure the data quality of the drug development program, this article examines the practical aspects of reporting deaths due to the main disease progression.
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Phase I Subject Satisfaction: A Rare Look
Sherilyn Adcock, PhD, John Sramek, Kurt Hauptmann, Hong Ding, Keith Fern, Neal R. Cutler, MD
While satisfaction surveys have been used for decades in healthcare, little such data has been collected from volunteers in the early clinical research setting. Authors provide a rare formal analysis of satisfaction levels of healthy subjects in Phase I trials, where determinations, though often overlooked, are essential drivers of the clinical trial process.
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NEWS
View From Washington: Jill Wechsler on renewed action to update the “Common Rule” and proposed changes for IRBs and informed consent.
View From Brussels: Peter O’Donnell highlights several European initiatives underway that promote syncing new science with clinical trials.
Global Report: Philip Ward relays the “strategic musts” from top investigator on addressing conflicts unique to industry-sponsored trials.
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CLINICAL TRIAL INSIGHTS
eClinical Chasm: Usage vs. Impact
Ken Getz
Survey reveals new benchmarks on e-solutions adoption for clinical trials, but finding ways to credibly quantify return on technology investment is needed. |
CLOSING THOUGHT
Alzheimer's & Patient Safety
John Hubbard, PhD
Patient-centric practices aligned with personalized medicine, biomarker use, and patient recruitment have transformed the design of Alzheimer’s disease studies. |
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lhenderson@advanstar.com
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