It’s easy to give a sharp salute to "quality." What modern research organization would oppose it? Quality refrigerators, quality cars, quality overnight packages can be defined easily. Quality in a clinical trial is a bit murkier. By definition, every trial is one of a kind, with clinical, operational, regulatory and technological aspects that are unique. Having said…more...

Editor's Note: Through association with certain spiritual mentalists and accredited acupuncturists, the editor of ClinPage has received what he has been assured is a bonafide transcript from nine years in the future. From the year 2019, to be precise. The transcript below purports to be the byproduct of a U.S. Freedom of Information Act (FOIA) request. It…more...

Some people are happy with incremental progress. A long career in drug safety has left Michael Ibara searching for a bigger leap forward. He's the architect of a potential alternative to the present drug safety morass of paper, faxes, and inefficiency. As head of pharmacovigilance information management at Pfizer, Ibara organized the Aster project, an exploration of…more...

If pharmacovigilance were a movie, it would be Groundhog Day, except as a tragedy. Here's the plot. Reports of adverse events (AE) pop up and take years to be evaluated. The associated recriminations bounce between various interested parties. Good drugs exit the market. Bad ones linger. The industry's reputation gets bludgeoned either way. Luck is at work,…more...

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...