We asked Quintiles to tell us about one of the most improved sites or site networks in its five-year-old partner sites program. The contract research organization (CRO) introduced us to Piedmont Medical Research, a group of 11 sites in North Carolina, South Carolina and Tennessee. The network is based in Winston-Salem, N.C. It's comprised of nine sites…more...

If the International Alliance of Patients Organizations (IAPO) gets its way, patients will soon sit at the table with scientists to offer input into the design of study protocols. Not in a forceful or adversarial way, says Jeremiah Mwangi, IAPO's senior policy officer, but in a way that benefits everyone. Picture, for example, a pediatric epilepsy trial…more...

If clinical research were managed like a business, clinical sites would be rewarded for meeting or exceeding patient enrollment targets. But the issue is more complex for both ethical and operational reasons. Some research sites, even poorly performing ones, are appropriately coddled in the service of larger scientific or marketing objectives. And any elevation of a few…more...

When French pharmaceutical company Sanofi-Aventis (SA) recently gathered representatives from several investigator sites to ask them for feedback, the drug maker got a shock. An SA executive began to talk about an electronic collaboration portal, one where sites could interact with the sponsor, and he got cut off by what amounted to boos and hisses. “Turned out,…more...

In 2006, Johnson & Johnson got hit with a frying pan to the face when the BBC ran an interview with a man involved in a J&J trial on the anti-psychotic Respiradil. The study subject had bipolar disorder, and was told by his doctor that the drug he had been taking was suddenly discontinued and he needed…more...

India! India! Everybody's jumping on the bandwagon. PricewaterhouseCoopers declared recently that “the center of gravity of the global pharmaceutical industry is shifting,” with Asia set to be the world’s largest pharmaceutical market, and India one of the powerhouses of the industry. Then there's KPMG, which estimates that India has the potential to emerge as the foremost destination…more...

You can look at patient recruitment as an operational problem. Or as a mathematical challenge. Rob Laurens, director of creative services at BBK Worldwide, would certainly understand those perspectives. But there is also the marketing savvy that helps patients understand whether a trial is right for them.  Laurens spoke about rescue trials at this month’s Clinical Trials…more...

One surprising aspect of the clinical trial landscape is just how few PhDs and physicians share their knowledge, either as industry insiders or academic researchers. The vastness of the global research enterprise does necessarily involve large numbers of other professionals. We know that. But hearing from the experts now and then is nice. We get a large…more...