Outsourcing-pharma.com spoke with Avoca CEO Patricia Leuchten who explained that financial and time pressures sponsors and CROs are under impact how such organisations work together and make measuring the quality of outsourced clinical research more important than ever.
"In a recent survey where we gathered data from both sponsors and CROs we were really struck by the incredible pressure the industry is under to achieve greater levels of efficiency and shorter timelines and we wanted to take a look at how this is affecting the quality of outsourced trials."
She explained that the group's examination of sponsor and CRO satisfaction levels and expectations, combined with an assessment of approaches to relationship management and monitoring, produced some unexpected findings.
"I was very surprised by the differences in the responses," Leuchten continued, explaining that only half of the sponsors were satisfied with providers' delivery of quality overall whereas the CROs surveyed feel that they are doing a good job and are providing high quality services.
Pricing pressure and communication
The reason for the disconnect - based on Avoca's qualitative and quantitative research - is that CROs feel that while they are well placed to delivery high service quality, sponsor activities and price demands often impede service delivery.
"Sometimes the negotiations in terms of what sponsors will pay for in terms of quality are sometimes a barrier," she said, adding that "CROs feel that the incredible price pressure they are under...has had an impact.
"The other issue is that CROs sometimes feel they are not involved early enough in decision making about things that have an impact on quality. For example, sponsors sometimes are choosing the investigators, choosing the third-party vendors, determining protocol design and when CROs are responsible for the actual quality but don't have input into factors that impact quality that is where they feel that the disconnect lies."
Keys to quality success
However, although the study findings suggest there is still some distance between sponsors and CROs on quality, they also indicate that formal quality agreements and accurate performance metrics provide a way of bridging the gap.
“We found that the [sponsor] companies that do a very good job of documenting their quality expectations…at the very beginning of a clinical trial are actually having much better outcomes.”
“The other area is metrics, “Leuchten continued, adding that the 50 per cent of pharma respondents that believe such measurements provide a true picture of performance are among the most satisfied with the quality of the services they receive.
Next steps
Avoca has established an industry consortium - which includes Big Pharma firms like Pfizer and Eli Lilly as well as leading CROs - to discuss and try to address these issues, beginning with a benchmarking study targeting quality agreements and quality metrics.
“There is an opportunity to make great strides in the industry and eventually create some industry standards that will have an impact overall in terms of the quality of outsourced clinical trials.”
The Avoca Group’s full 2011 report “Maintaining Efficiency While Ensuring Effective Quality Oversight of CROs” Can be purchased here.
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