Applied Clinical Trials-10-01-2015

Addressing the challenges unique to purely industry-sponsored trials is explored.

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Several initiatives are focused on integrating biomarkers and personalized medicine techniques into studies.

Aligning patient-centric approaches with personalized medicine and biomarker use is transforming the design of Alzheimer's trials.

A review of public data indicates a small increase in Phase III inclusion/exclusion criteria per trial over a five-year period.

Survey provides new benchmarks on e-solutions adoption, but actual impact data remains elusive.

This experimental technique is being studied to see whether it could treat certain health problems.

Examining the practical significance of reporting patient deaths due to main disease progression.

Using a specific trial, the importance of assessing the success of therapy masking is examined.

Survey applies rigorous analysis to provide a rare formal look at volunteer satisfaction in early setting.

Trial Design: Gene Transfer: Key Challenges Therapy Masking Assessment Safety Reporting: Death Waivers Fall Short Subject Engagement: Phase I Satisfaction Scores Also in this issue: Informed Consent Changes in Works Europe's Embrace of New Science Alzheimer's and Patient Safety