All about that base: Risk-based monitoring takes center stage

A roundtable of experts from Eli Lilly, Boehringer Ingelheim and Bristol-Myers Squibb (BMS) on Wednesday at the Partnerships in Clinical Trials conference in Boston spoke in depth about their company strategies, as well as how they’re working with CROs to identify site risks.

All three experts seemed to agree that although RBM programs will vary company to company as there’s no off-the-shelf solution, heavily relying on SDV is not valuable, though research companies in 2014 spent billions on SDV​.

Rehbar Tayyabkhan, executive director of global clinical development at BMS, said that his company “is pretty much all in” ​in terms of adopting RBM across its clinical research programs. When the company first started using RBM, he said, it wanted to keep it internal, and now today with its CRO partners, “the goal is to leverage their capabilities​,” particularly on the analytics end, though BMS will “still own the risk assessment processes​.”

For Lilly, which outsources all of its work with CRAs (clinical research associates), Gary Thompson, senior director of data sciences and solutions, said that over the last year and half the company has worked in different ways with CROs, including through pilot programs and other functional approaches.

Lilly has introduced RBM into 40 of its trials, Thompson said, noting that the company is now focused on its tool set and analytical approach.

Andy Lawton, global head of data management at Boehringer Ingelheim, added that his company is still dealing with the basic challenges of RBM, particularly with centralized monitoring.

“We’re having to move more into a role of source data review​,” he added, noting that it’s an evolving process.

PPD, Shire Collaboration​

Experts from CRO PPD and rare disease drug developer Shire also discussed their collaborative process in adopting RBM, which at the outset seemed difficult because trials with rare disease patients can be extremely sensitive when it comes to the data.

Courtney Bryant, clinical process optimization director at Shire, said that flexibility has been key as the company has been training teams internally with the TransCelerate modules, and then working with PPD once the foundation was set up.

Nicole Stansbury, executive director for remote site management at PPD, added that RBM can really help companies looking to understand which sites are high-risk. Although even for organizations that fully support RBM, there will be some employees at the sites who don’t support some component of it, she cautioned.

FDA Response​

As far as how the FDA has reacted to various approaches, all three experts from Lilly, BI and BMS agree that the agency has been positive, though the agency still asks companies that adopt different approaches to define what they mean by RBM, and how they made particular decisions around its use.

“FDA has been very positive around RBM as they’ve worked with us on 8 pilots,”​ Tayyabkhan said, noting that the data sets have yet to be submitted to the agency.