News

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

The successful implementation of centralized monitoring requires effective planning, process restructuring, cross-functional expertise alignment, and the right technology in place.

Rasi was forced to step down in November 2014 by the EU Civil Service Tribunal after a panel of experts found the European Commission (EC) had used improper procedures when it had selected him back in 2011.

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

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

As the use of PRO expands in clinical trials, ePRO vendors themselveshave expanded beyond this constrained definition. Increasingly, the use of eCOA is being used to encompass all data collected related to the patient, which includes PRO, clinician reported (ClinRO) and observer or caregiver reported outcomes (ObsRO). Further, with mobile health technology use growing in general healthcare, that use is changing outcomes data collection in clinical trials. This e-Book tackles the changing world of PRO collection in clinical trials.

PCCTC will utilize its services for the review of its cancer research protocols and related study documents.

Features of the Centralized Data Surveillance include: • Assessing protocol risks, needs and key performance metrics such as site proficiency, calibration, rest between maneuvers, protocol adherence, acceptable/unacceptable Best Test Review data errors impacting the start of tests, and amount of data with repeatability issues