FDA collaborating with RBM software provider to enhance trial oversight

By Melissa Fassbender contact

- Last updated on GMT

The FDA has signed a cooperative development and research agreement (CRADA) with CluePoints. (Image: iStock/shironosov)
The FDA has signed a cooperative development and research agreement (CRADA) with CluePoints. (Image: iStock/shironosov)

Related tags: Food and drug administration, Scientific method

The US Food and Drug Administration (FDA) has signed an agreement with CluePoints to "further explore" a data-driven approach to quality oversight in clinical trials.

CluePoints provides a Software-as-a-Service (SaaS) solution, which uses a suite of statistical algorithms to interrogate clinical and operational data in order to improve data quality, focus monitoring efforts, improve patient safety, and mitigate risk in clinical trials.

Sponsors and CROs are either adopting the technology themselves to analyze data at an enterprise level or using CluePoints’ data scientists to use the software in order to target sites and patients at risk, based on the resulting signals​,” Patrick Hughes, Chief Commercial Officer at CluePoints, told Outsourcing-Pharma.com.

This methodology is recommended​ as part of various regulatory guidance documents, including FDA’s RBM (risk based monitoring)​ Guidance, EMA’s reflection paper, and ICH E6 Rev 2.

Hughes explained that the approach “provides a cost-effective and timely way to objectively assess data quality and conduct monitoring activities targeted at sites at risk​.”

The resulting cost savings from significantly reduced monitoring efforts and improved data quality before submission are positively impacting on both reducing operational costs and preventing submission delays and subsequent issues​,” added Hughes.

While the FDA has developed its own techniques for this type of methodology, Hughes explained that the administration sees the cooperative development and research agreement (CRADA) with CluePoints as a way to accelerate and enhance the approach.

Hughes explained that the data driven approach will provide the FDA with the opportunity to “further explore, enhance and accelerate its approach to selecting sites which exhibit data anomalies​.”

As per the CRADA, anticipated benefits include the detection of anomalous sites which may have escaped detection previously, rapid turnaround of results, the ability to determine the nature and extent of data anomalies, and the ability to explore the interaction of various factors with data quality. 

These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations​,” according to the CRADA.

The next step will involve CluePoints and the FDA working in partnership to install the CluePoints software on site at the FDA and to “allow its High Performance Computing platform to drive analysis of existing data to determine where the enhancements will be applied​,” Hughes said.

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