It’s no secret pharmaceutical companies are outsourcing more and more work to clinical research organizations. But when it comes to recruiting doctors to run the studies, they’re not happy at all. In fact, many pharma companies would prefer to do that work themselves.
If given the option, nearly half of pharmaceutical companies surveyed by research firm Industry Standard Research — 48 percent — would keep clinical trial investigator and site selection services in house. The pharmaceutical outsourcing trend will continue as pharmas continue to seek cost savings, said Kevin Olson, ISR’s CEO. But they’ll be “dissatisfied outsourcers” until the CRO industry turns investigator recruitment around.
ISR’s new investigator report is based on a survey of 116 pharmaceutical decision-makers whose job specifically involves investigator recruitment. The survey respondents were asked to evaluate 12 CROs: Quintiles, Covance (NYSE:CVD), ICON (NASDAQ:ICLR), INC Research (including acquisition Kendle), Medpace, Optum Insight (formerly Ingenix), Parexel (NASDAQ:PRXL), PharmaNet/i3, PPD, PRA, Premier Research, and Theorem Clinical Research (formerly Omnicare).
Quintiles was the top CRO overall in terms of having the most productive investigator database, according to survey responses. But the Durham company was not perceived as the best in all categories. Raleigh-based CRO INC Research, for example, was the top CRO for recruiting oncology investigators.
As an industry, Olson said that CRO investigator databases get poor marks. The wave of CRO consolidation ends up hurting investigator recruitment. Data are housed in multiple systems that are not adequately updated and maintained. That means spotty records that make recruitment inefficient. Investigator recruitment is more difficult outside of the United States and Western Europe, Olson said. The West has well-established clinical trial infrastructure to recruit patients and investigators through hospitals and universities. For all of the industry talk of growing in emerging markets, the clinical trial infrastructure in these markets has yet to see the same industry investment, Olson said. Emerging markets do boast an abundance of potential patients for clinical studies. But Olson said there’s a dearth of qualified sites to recruit patients and the doctors for the trials. “The (emerging markets) opportunity might be outstripping the level of investment they’re putting into that,” Olson said.
About one-third of the time, a CRO contracted for clinical trial work will handle recruiting for all of the sites in a study. That’s close to 2009 figures when an ISR survey found that CROs handle all of the recruiting 37 percent of the time. The 48 percent of pharma survey respondents who would bring clinical trial site selection in house is actually down from 68 percent in 2009. Olson said that this drop doesn’t appear to be explained by better performance as CROs continue to struggle to meet recruitment expectations. Olson hypothesizes that sponsors are simply coming to terms with the increasing trend to outsource across the entire spectrum of clinical development activities.
As much as pharmaceutical companies would like to bring more recruiting in house, they can’t. Just 28 percent of pharmas surveyed have internal staff dedicated to identifying and training new sites. Olson said that the recruitment challenges represent a problem for both CROs and pharmas. Recruitment could perhaps be improved through cooperation coordinated between industry groups the Association of Clinical Research Organizations and PhRMA, Olson said. But he adds that if one company builds out clinical trial infrastructure to improve recruitment, those sites could also be used by others. In other words, a company could end up helping a competitor.
“Perhaps that’s a barrier to them,” Olson said.