Overall, CROs received a combined excellent/good rating of 80%, a 2% increase from 2013, though the proportion of sites giving the average CRO an excellent rating has nearly doubled in the past decade. The average CRO also improved its performance in working effectively with sponsors and conducting clear study initiation visits and training.
However, more than half of sites surveyed gave CROs low marks for ensuring study monitors are well-trained and understand the protocol, have the ability to resolve problems quickly, and are adequate at patient recruitment support and timely grant payments. The biggest challenges identified areas related to providing knowledgeable, well-trained monitors; organized and prepared study support; staff easily accessible to solve problems; fair grant payment amounts and prompt payment schedules.
The Winners and Losers
“Five CROs came out on top: PSI CRO, INC Research, Chiltern, PPD and Covance,” according to the CenterWatch researchers. “INC Research, PPD and Covance also ranked among the top five CROs in the 2013 survey….which suggests CROs are getting better at creating continuity in management practices and strategies adopted in recent years to improve site relationships are beginning to pay off.”
Quintiles placed sixth on this year’s list, while numbers seven to 11 went to Medpace, Icon, PRA Health Sciences, Parexel and inVentiv.
“The results underscore how CROs, under mounting pressure to achieve higher levels of performance and efficiency, have focused efforts in recent years on developing more effective relationships with sites to improve clinical trial operations,” authors Karyn Korieth andAnnick Anderson wrote.
CenterWatch’s 2015 Global Investigative Site Survey was conducted online from October 2014 through early January, and asked Principal Investigators, Sub-Investigators and Study Coordinators to rate the CROs with which they worked during the past two years on 37 project attributes. In addition, sites provided feedback on the importance of these attributes in conducting successful clinical trials.
As in previous surveys, sponsors continue to receive generally higher excellent ratings than CROs for site relationship quality. CROs scored two to four percentage points lower than sponsors in each of the six project categories measured. The widest variability between CROs and sponsors was for having professional medical staff in clinical operations: 56% of site professionals gave sponsors an excellent rating, compared to only 49% for CROs. Sponsors also received higher ratings for having efficient administrative teams and easily accessible staff.
“Another notable gap was for providing ongoing help in running a study, an individual attribute within the study monitoring support category, for which the positive rating for sponsors was six percentage points higher than that given to CROs,” CenterWatch said.
And some aspects of the survey haven’t changed over time. In the widest gap, 71% of sites believe professional, knowledgeable CRAs (clinical research associates) are critical to study success, but only 48% of sites gave the average CRO an excellent rating for this attribute; this area also had the widest performance gap in the 2013 survey.
Clare Grace, Vice President Site and Patient Access at INC Research, told Outsourcing-Pharma.com that one of the sticking points left to be dealt with between CROs and investigator sites is the way that sites are paid on a quarterly, rather than monthly, basis.
“For CROs to build stronger relationship with sites, they must ensure CRAs are properly trained and understand the protocol; communicate in a respectful, timely manner; offer adequate funding for patient recruitment; offer organized study support and improve grant negotiation and payment processes,” the authors wrote.