Risk-assessment approach outlined for biomarker-driven clinical trials

A practical risk-management approach for effectively integrating biomarkers into cancer clinical trials has been outlined by a working group with members from the US National Cancer Institute (NCI), the United Kingdom National Cancer Research Institute (NCRI), and the European Organisation for Research and Treatment of Cancer (EORTC).

Their work provides the international community with a set of common principles by which biomarkers can be integrated into clinical trials, exchange of data can be facilitated, quality promoted, and research accelerated. Also, it simultaneously respects local approaches and legislation. The approach from this working group was published in The Lancet Oncology (2014; doi:10.1016/S1470-2045(13)70607-7).

Their risk-assessment approach for designing and conducting cancer clinical trials includes risks to patient safety, operational risks, and biomarker development risks. For each risk, they evaluated possible consequences and provided solutions along with examples of these. They also provided references to helpful resources.

Concerning protocol design, the working group recommended items that a protocol should include as well as items that should be assessed during protocol development. For the conduct of the trial, they made recommendations for the close monitoring of variability in test results, and they also made recommendations for particular aspects following completion of the trial.

Dr. Jacqueline Hall, who coordinated this NCI, NCRI, and EORTC working group said, “We readily acknowledge that in today's clinical trial landscape, many stakeholders play a role in clinical trials. These include regulators, public authorities, and patients, amongst others. By opening this discussion to others, we hope to find solutions to the varied challenges facing molecularly-driven clinical research.”

The group explained that their publication outlines a consensus framework. It uses a novel and practical risk-assessment approach that can be used internationally. Their hope is that biomarkers will ultimately be developed that can readily be integrated into routine practice.

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