Video: Introduction to Data Monitoring Committees

Transcript

The way we conduct clinical research is changing. More studies now require oversight from an independent Data Monitoring Committee than ever before. Data Monitoring Committees, or DMCs, are also known as Data Safety Monitoring Boards. They are required when a trusted third party is necessary to independently assess clinical trial data.

Many trials are “blinded,” meaning neither the investigators nor the sponsor know which study participants are getting what dose or placebo. But someone needs to look at the data during the study to see if the investigational drug is working as outlined in the protocol, or if it’s causing an unplanned safety issue. A DMC provides an independent assessment regarding the risks of the study drug and can recommend stopping the study early if the study drug does not appear to be working.

The independence of the Data Monitoring Committee is paramount. Regulators in the US and EU require this oversight function be conducted by an independent group. Someone separate from those conducting the research who can provide an unbiased evaluation of the data. Sponsors and CROs should not perform this function themselves. Having an independent party evaluating the data eliminates any potential concern that the review was not impartial.

With more than twenty years experience and a worldwide network of over 1,500 medical, biostatistical, and clinical research professionals, Advarra is the research industry’s most experienced provider of Data Monitoring Committees. While the DMC acts independently of Advarra’s other oversight committees, our experienced team works with the sponsor to develop the DMC charter and proactively discuss any issues during analysis.

Advarra’s DMC administration is fast: Get your DMC written recommendation within one business day after the meeting. Are you ready to experience a new level of collaboration with your independent DMC? Leverage the world’s largest, truly integrated, independent review service and make Advarra your first choice for data safety monitoring.

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