Initial estimates show that risk-based monitoring can save sponsors and CROs between 15% and 20% in study portfolio costs, according to the report. But PwC says sponsors and CROs have so far been reluctant to adopt more risk-based approaches.
“The industry is in turmoil in how to best pursue risk-based monitoring approaches,” Dr. Robert Franco, a principal in the PwC Life Sciences practice, told Outsourcing-Pharma.com. “We wanted to highlight that there’s a stepwise approach for risk-based monitoring -- it isn’t all or nothing.”
The PwC algorithm uses two types of risk as inputs: fixed and dynamic risks. Fixed risks involve those related to a trial protocol -- such as the therapeutic area, drug safety profile, target product profile -- and study site risks, such as site experience, location and the number of study coordinators. Dynamic risks, meanwhile, are related to the real-time evaluation of risk and involve enrollment rate, protocol deviations and adverse events.
PwC recommends varying the types of monitoring of sites to include targeted, remote and centralized monitoring to reduce the amount of source document verification.
Franco emphasized the spectrum of risk-based monitoring that’s available – from reduced monitoring at less risky sites to remote or targeted monitoring, which can be more disruptive for sponsors or CROs to implement. The PwC report is based on discussions the company conducted with large pharma companies and CROs, many of which “are now just starting to put the infrastructure in place,” Franco said.
He added that companies should also aggregate and compile risk-based data so they can investigate trends or patterns to root out fraud or find where trial protocols might not be interpreted properly.
The push for more risk-based trial monitoring follows guidance from the US FDA in late 2011 that encourages sponsors to rely less on on-site monitoring of trials and to use a more centralized approach.
Software for Monitoring, Inspections
CROs have also begun to shift away from on-site monitoring in favour of software that can be used to monitor trials remotely.
In addition, regulators are using new technology to track and conduct trial inspections. The UK’s MHRA (Medicines Health and Regulatory Agency) announced Tuesday it’s rolling out Accenture and Oracle software that will store all information from previous trial site inspections and use a statistical algorithm to compare data against previous and/or current issues to help inform the inspection planning and process.
The full potential of the software will not be seen until between 12 and 18 months after it’s installed, according to the MHRA.