Medidata and TransCelerate beat the drum for risk-based monitoring

Medidata ($MDSO) and partner TransCelerate BioPharma, a nonprofit run by the world's largest drugmakers, are amplifying their call for clinical trial runners to embrace new technology, unveiling study results that support the adoption of risk-based monitoring (RBM).

In collaboration with TransCelerate, Medidata took a look at its own data from more than 7,000 clinical trials to determine whether source data verification (SDV), in which investigators cross-check case reports with original documents, is an effective way of policing trials. The company found that only 1.1% of site-entered case report data are corrected as a result of SDV, results Medidata said confirm the relative unimportance of the method.

In contrast, more adaptive approaches like source data review, in which investigators vet data quality throughout the process, proved more valuable, according to the study, a finding TransCelerate says supports a risk-based approach to quality control.

TransCelerate CEO Dalvir Gill

"What we learned through our joint research initiative confirms that SDV is not effective at identifying systemic errors or substantially improving the quality of data gathered," TransCelerate CEO Dalvir Gill said in a statement. "These findings support the approach TransCelerate has outlined for high-quality RBM, which we believe will be an effective and efficient methodology for all organizations conducting clinical trials worldwide."

Medidata signed a deal with TransCelerate earlier this year to help the group pile up data to support a widespread adoption of RBM. In the process, Medidata will get the chance to show off its technology to TransCelerate's big-name membership, which includes GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ), Pfizer ($PFE) and Roche ($RHHBY).

Since its launch in 2012, TransCelerate has focused on ways to help Big Pharma share resources and stop wasting time and money on noncompetitive work, looking to standardize how sponsors communicate with sites, monitor trial results and anonymize data. The Philadelphia-headquartered nonprofit has also signed a deal with Cognizant ($CTSH) to help standardize how sponsors and sites communicate.

- read the statement

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