Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.
The business analytics firm’s CEO, Moe Alsumidaie, told Outsourcing-Pharma.com that most industry insiders do not fully understand the US Food and Drug Administration’s recent guidelines over risk-based monitoring of clinical trials.
He said firms are currently needlessly checking every piece of data related to a clinical trial for accuracy, including data not central to the FDA’s key mission; “to protect the patient and integrity of medical product”.
By simply quality checking (QC) representative sections of peripheral information – such as research coordinator payment forms – to demonstrate an average accuracy level, he believes time and costs could be saved.
“It’s apparent the reason there is a lack of understanding is that people don’t really know how to assess risk,” he said. “Usually you shouldn’t have to QC more than 15 per cent of some data for the FDA to see due diligence. If it is a high risk area, then obviously 100 per cent QC is necessary.
“But aspects such as study site payments and monitoring travel costs assisted with monitoring accounts for 65 per cent of total costs. If you are able to centralise monitoring that’s huge.”
He stressed however that though some data may be deemed “none-central” to FDA goals, failing to QC any of it is unacceptable.
“For low risk aspects you could just say I won’t check the QC – but that doesn’t set off a very good image to the authorities. They might then go deeper into other areas to see you haven’t missed anything,” he said.
Conflict of interests?
Alsumidaie also spoke about risk-based monitoring requirements for sponsors and CROs to pay closer attention to “riskier” trial, in place of more rigid traditional guidance which suggests inspection once every four to six weeks regardless of risk.
The guidelines also stipulate that the more trusted sites may be monitored less rigorously.
When Alsumidaie told us it is up to the sponsors and CROs to determine which of their sites are high risk, we asked whether this could create a conflict of interest as site monitoring is costly and time consuming.
However he believes that with the end goal for both industry and the FDA being safe and efficacious medical products, leaving more decisions to sponsors and CROs is safe.
“No one wants an unsafe or in-effective product on the market,” he said. “You want to select a site that is going to conduct good clinical practices and enable the FDA to hear about good clinical outcomes. Sponsors don’t want to take any sort of risk that would prohibit them from approving medical product with the FDA.”
He added that the FDA is putting a lot of trust in the industry over its risk-based monitoring guidance, and went as far as to say the organisation will establish regulations based upon industry’s reaction.
“It is important to know that the FDA does leave their guidance open to interpretation and it is up to the company to implement these guidelines. I think they trust the industry, see what they have to present and will change regulations accordingly.”