Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

We asked experts how the regulators will cope with flexible risk-based monitoring systems

Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

The risk-based model determines the frequency and intensity of site inspections according to a number of factors, including therapeutic area, trial design and the facility’s history. Many welcome the move because it could mean less inspections are needed – therefore saving costs.

However many attendees and speakers at Partnerships in Clinical Trials (PCT) believe there is still a lack of clear guidance over conducting risk-based monitoring, and are urging authorities like the US Food and Drug Administration (FDA) and the EMA (European Medicines Agency) to create more solid rules.

But with the inherent flexibility of risk-based trial observation, will it be possible to turn guidance into more rigid regulations?

United BioSource’s executive director of clinical operations Hazel Wohlfahrt told Outsourcing-Pharma.com a solution could be categorising the therapies  used in a study into high, medium and low risk and then monitoring the sites accordingly.  

"I think the main problem is that there is no base regulations. They're going to have to establish a model. We need a scheme with A, B and C creating categories in reference to the type of risk that that product would fall into," she explained.

Perceptive Informatics’ director of business development Ralf Oxenfarth said risk-based monitoring should be aimed mainly at making trials safer for patients, and that regulators should consider how electronic data capture (EDC) systems could help.

He said: "I think if regulators take a positive approach to more risk-based monitoring this would be helpful for this industry. Currently a lot of initiatives, we from a technology point of view are able to provide some services within our EDC system to support RBM especially when it comes to source-data verification."

Nevertheless, there were still some - such as Icon’s senior VP of data management Dermot Kenny - who believe the current draft guidance available is clear enough, and that transparency will improve further when guidance documents are released.

He said: "I think it's up to the industry to demonstrate that they understand how to measure risk and that they are able to design trials that deliver a clean data base from a risk-based approach and the best companies that do that will be excepted by the regulators, but I don't think that's much different from today."

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