TransCelerate shares its take on risk-based monitoring models and tech

With clinical trial sponsors spending a sizable chunk of their huge Phase III trial budgets on source data verification (SDV) in return for questionable benefits, risk-based monitoring is an obvious target for TransCelerate BioPharma's R&D efficiency agenda. The Big Pharma consortium has further clarified its thinking on the topic in two research papers.

TransCelerate published both papers in the Drug Information Association's Therapeutic Innovation & Regulatory Science journal. The first of the two papers--which is authored by staffers at AstraZeneca ($AZN), Eli Lilly ($LLY), Pfizer ($PFE) and other Big Pharma firms--discusses the models companies are using as they move toward centralized monitoring of clinical trials. Successful implementation of such models is vital to the strategy of lessening trial oversight costs while maintaining quality.

"Successful implementation of risk-based monitoring is dependent on being able to operationalize the concepts effectively through multiple considerations, including process, people and technology. Risk assessment, central monitoring and technology to scale the methodology are all important for success," Brett Wilson, associate director of business operations at Bristol-Myers Squibb ($BMY), said in a statement.

The second paper deals directly with the technologies that can enable risk-based monitoring. The paper lays out the ways in which trial sponsors can collect and use data to remotely oversee trial sites, while also calling for technology vendors to tailor their products to the new way of working. "A simple example is that most systems now have the ability to track SDV conducted by a monitor, whether at the site or remotely," the authors wrote. More changes of this type will be needed in the future.

- read the press release
- check out the first paper (PDF)
- and the second study (reg. req.)

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