Trial site-CRO relationships improving over time, survey finds

By Zachary Brennan contact

- Last updated on GMT

CROs (contract research organizations) received slightly better overall ratings from investigator sites compared to two years ago, though there are still gaps between how sites view sponsors and CROs, according to the recently unveiled CenterWatch Global Investigative Site Survey.

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.

Gaps

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.

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