International Effort Produces Risk Management Plan for Functional Imaging in Cancer Clinical Trials

A joint effort from the European Organisation of Research and Treatment of Cancer (EORTC), the European Association of Nuclear Medicine (EANM), the European Society of Radiology (ESR), and the United States National Cancer Institute (NCI) has resulted in establishing a foundation to improve the implementation and use of imaging biomarkers in cancer clinical trials, according to a report in Lancet Oncology (doi:10.1016/S1470-2045(15)00164-3).

"In cancer clinical trials, we are always trying to strike the right balance between maximizing data quality and minimizing cost,” said lead author Yan Liu, MD, Head of the EORTC Translational Research, Radiotherapy, and Imaging Department. “Here, risk management can be an extremely helpful tool, because it can help us to prioritize, reduce costs, and decrease attrition rates.

“In our study, we used a quality risk management approach to help us outline a consensus framework for imaging biomarker driven trials. This approach recognizes that other stakeholders such as regulatory bodies, pharmaceutical companies, and patients also play essential roles in the conduct of these trials."

"Over the past several years, molecular and functional imaging tools have advanced to the point where it is now widely used in cancer clinical research," said Lalitha Shankar, MD, of the NCI Clinical Trials Branch, Cancer Imaging Program. "Currently, RECIST, Response Evaluation Criteria In Solid Tumors, is the most commonly used criteria for the assessment of treatment response. But molecular and functional imaging can provide valuable information on disease staging as well as characterization and potentially allow detection of response or nonresponse within days of the onset of treatment."

"Such early stage detection could make it possible for nonresponding patients to avoid unnecessary toxicity related to therapy,” said Nandita Desouza, MD, of the Institute of Cancer Research Royal Marsden Hospital in the United Kingdom. “Developing and using imaging biomarkers, however, is complex.” Data acquisition methods are quite involved, regulatory issues need to be considered when trialling new imaging agents, and image postprocessing with advanced multivendor software is not trivial, Desouza explained. Furthermore, lack of rigorous quality control can result in increased data variability, especially in multicenter international trials.

EORTC, EANM, ESR, and NCI researchers banded together to propose a practical risk-based framework and recommendations on imaging biomarker driven trials that include identifying risks at trial initiation, which allows for resources to be better allocated and key tasks prioritized.

The authors recommend developing a risk assessment plan prior to study initiation for utilization during protocol development, site activation, accrual, and at the end of the trial. A multidisciplinary team that incudes imaging experts and oncologists, as well as the study project managers, would develop the assessment. Furthermore, the risk assessment plan should be reviewed and updated throughout the trial to ensure that actions have been or will be taken.

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