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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

Considerations for Using a Mobile Medical App as an Investigational Device

The authors concluded that its secondary analysis of existing data from Study 329 demonstrated clinically significant increases in harms, including suicidal ideation and behavior (SIB) and other serious adverse events in individuals taking paroxetine.

Amid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.

Washington correspondent Jill Wechsler reports on Janet Woodcock's explanation to Congress last week on the FDA’s lengthy and deliberative process for issuing important policy advisories on biosimilar naming, labeling and interchangeability.