These days, can a clinical development program have too much safety? While risk evaluation and mitigation strategies (REMS) are hardly new, as this list of them on the FDA website attests, they remain only partially understood. In its own conversations with the sponsor community, Quintiles realized that many in the industry are unaware of the full spectrum…more...

Is the pharmaceutical industry managing and assessing electrocardiograms (ECGs) as rigorously as it could? As consistently as it should? Should the FDA transition away from paper ECGs? Jeffrey Litwin has a delicate line to walk. On the one hand, as chief medical officer and executive vice president of ERT (until recently known as eResearch Technology), his company…more...

Cardiology diagnostics technology firm NewCardio hopes to transform a key sector of the industry: the way cardiac safety is monitored in clinical trials. They’re not there yet, but the company has a formidable executive roster.  Four-year-old NewCardio—hard at work on roll-out plans for multiple products—is small. It has just 10 employees and is traded as a penny…more...

Blame Avandia. It was that diabetes blockbuster’s black box warning late in 2007 that got Jonathan Goldman thinking.  Chief medical officer of Icon Medical Imaging, Goldman pondered whether the FDA would start requiring diabetes drug developers to do more to monitor cardiovascular events. Then, last summer, the FDA’s endocrinologic and metabolic drugs advisory committee met. That galvanized…more...

Twenty six patients. Eleven patients. Three patients. Despite the billions spent on clinical research, regulatory decisions often boil down to adverse events in a handful of patients. There are widely divergent views on whether the small numbers are statistically sufficient. But no one would argue that casting a wider net could be good for science, industry and…more...

As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on a Wyeth anti-nausea drug. The legal debate is stark: can the FDA’s approval take precedence, or “preempt,” state courts hearing liability cases? Earlier this year, we…more...

Sydney “Syd” Wolfe, director of Public Citizen’s health research group, is scratching his head. Tequin (gatifloxacin)—an antibiotic that Public Citizen had campaigned against—was pulled from the market by its manufacturer, Bristol-Meyers Squibb (BMS). But BMS said that was because of lagging sales. That was two years ago. In September of this year, the FDA formally announced that…more...

Does the pharmaceutical industry need to rethink the management of drug safety data and pharmacovigilance? A few companies already are. That was clear at this year’s annual Society For Clinical Data Management (SCDM) meeting. Appropriately, the session tried to explore the tenuous technological links between two areas of human expertise: the medical interpretation of drug safety issues…more...