Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
The partnership will look to analyze the relative contribution of source document verification (SDV) to overall clinical data quality through the use of Medidata’s software. The findings will be analyzed with the intent of publishing the results in a paper co-authored by TransCelerate and Medidata.
Lawrence Florin at Medidata explained to OutsourcingPharma.com that the analytics provider is looking to use its database prioritized for risk-based monitoring (RBM) to help TransCelerate make industry generalizations on distinct RBM methodologies. He also noted that there are members of the consortium using Medidata tools individually.
The analysis is being conducted via Medidata’s comprehensive business analytics tool, which comprises data—collected over the last five years—from over 7,000 clinical trials across the globe involving more than 120 sponsor organizations.
Non-profit industry group TransCelerate -- which includes member companies such as AstraZeneca, Eli Lilly, Johnson and Johnson and GlaxoSmithKline – is more broadly looking to help advance innovation in research and development.
“Today we can leverage technology to change the model and find patterns of behaviour and confirm quality of performance at sites, and therefore assure the sponsors and CROs that patients are being managed properly,” Florin said. “At the end of the day, we’re looking for a mechanism to change behaviour and increase confidence that change in an approach can be comfortable.”
As CROs and sponsors turn to risk-based monitoring, there is an “enormous amount of runway in terms of gaining traction,” Florin added, as it’s “still very early in what companies are doing.”
Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a position paper in June 2013 and an update in early 2014 outlining an approach for RBM that can be adopted for any type, phase and stage of a clinical trial. The framework provided includes tools and triggers to help the industry identify and categorize risks.
The industry group has launched pilot projects, the intent of which is to inform TransCelerate members on how well the methods and tools work. On a quarterly basis, qualitative and quantitative feedback is proactively collected from member companies and then assessed for impact. TransCelerate expects there will be sufficient data in Q3 of 2014 to ensure these metrics are meaningful and worthy of sharing broadly.
In addition, Medidata and TransCelerate will publish a paper on the results that they’ve found, which Stephen Young at Medidata told us will hopefully come by the end of the summer.