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May 17, 2019

ACRO in US calls for risk-based monitoring of clinical trials

The Association of Clinical Research Organizations (ACRO) in the US has called for the adoption of risk-based monitoring (RBM) of clinical trials to ensure safer, efficient and quality studies.

The firm offered insights into RBM after discussions with former FDA commissioner Scott Gottlieb and the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing the technologies.

ACRO noted growing use of RBM and urged increased implementation of the oversight technologies.

Survey of ACRO member companies showed that less than 20% of new trials implemented some type of RBM oversight in 2016. However, the number increased by 2018, with most of the new studies using the technologies.

According to the firm, RBM is still limited due to various challenges such as preference of conventional oversight approaches that are believed to be low risk and less subject to critical analysis by the US and European Union (EU) regulators.

ACRO executive director Doug Peddicord said: “We look forward to continuing to provide the FDA with unique insights from our member companies. ACRO members are innovators in the development of RBM technologies.

“We are pleased to work with sponsors, research sites and the FDA to help ensure the safety of trial participants and the quality of the data submitted for new product approvals.”

The company noted that the FDA could aid in boosting RBM adoption by offering more straightforward support for risk-based monitoring approaches.

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