The New Drug Lag: EU Lags in Review Times of Monoclonal Antibodies.

Background: FDA had been criticized for its slow review of new drugs. Critics complained of a "drug lag" from which US patients suffered when compared to Europeans. Since the advent of PDUFA, however, the FDA has demonstrated a possible slight advantage in review time when compared to the EMA.

Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials.

Background: It is widely acknowledged that patient recruitment is a significant challenge and represents one of the primary reasons for drug development delays. Data from the Center for Information and Study on Clinical Research Participation (CISCRP) "Perceptions & Insights" study indicate that the 18- to 34-year-old Generation Y subgroup was the least willing to participate in a clinical trial.

Methods: The willingness of Generation Y to participate in clinical studies was compared to that of older groups in the CISCRP study.

Funding of Cancer Research: Do Levels Match Incidence and Mortality Rates?

The incidence and mortality rates of the ten most prevalent cancers types in the US were compared with the National Cancer Institute's funding of clinical studies in 2012. Additionally, a sampling of print and broadcast media coverage of these ten cancer types were gathered for the same year. While funding per case and per annual death broadly matched cancer prevalence, significant exceptions existed.

Reduction in Medication Errors: The Fentora Case Study.

Fentora (fentanyl citrate) is an analgesic opioid used in the management of breakthrough pain in adult cancer patients. Numerous reports of medication errors had been reported since the product's launch in 2006, 74% of which were prescribing errors. Subsequent to the initiation of a risk evaluation and mitigation strategy (REMS) by FDA and the sponsor in 2011, reports of prescribing errors dropped rapidly.

Changes to Prescription Drug Pediatric Labeling: Awareness by Practicing Pediatricians.

The US Congress and the US Food and Drug Administration encouraged studies in children so that the labeling information about pediatric use could be updated for pharmaceutical products. Pediatricians receive this updated labeling information through many different sources. A pilot survey was conducted to determine what source pediatricians use to learn about this updated information and whether and when they learned of specific changes.

Influence of Clinical Research Investigator Fraud on Clinical Trial Participation.

The number of clinical research investigators that the US Food and Drug Administration has disqualified or totally restricted has been increasing since 1964. In addition, several public polls and surveys indicate a major dilemma in clinical trial participation and public perceptions of clinical research. This study investigates how clinical investigator fraud or misconduct influences public perceptions of participation in clinical trials.