title: A risk management approach for imaging biomarker-driven clinical trials in oncology.
abstract: Imaging has steadily evolved in clinical cancer research as a result of improved conventional imaging methods and the innovation of new functional and molecular imaging techniques. Despite this evolution, the design and data quality derived from imaging within clinical trials are not ideal and gaps exist with paucity of optimised methods, constraints of trial operational support, and scarce resources. Difficulties associated with integrating imaging biomarkers into trials have been neglected compared with inclusion of tissue and blood biomarkers, largely because of inherent challenges in the complexity of imaging technologies, safety issues related to new imaging contrast media, standardisation of image acquisition across multivendor platforms, and various postprocessing options available with advanced software. Ignorance of these pitfalls directly affects the quality of the imaging read-out, leading to trial failure, particularly when imaging is a primary endpoint. Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks.
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium. Electronic address: yan.liu@eortc.be.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Cancer Research UK Cancer Imaging Centre, MRI Unit, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, Surrey, UK.
authors.forename: Nandita M
authors.initials: NM
authors.lastname: deSouza
authors.affiliation: Clinical Trial Branch, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Lalitha K
authors.initials: LK
authors.lastname: Shankar
authors.affiliation: Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Hans-Ulrich
authors.initials: HU
authors.lastname: Kauczor
authors.affiliation: The Center of Excellence for High Field MR, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Austria.
authors.forename: Siegfried
authors.initials: S
authors.lastname: Trattnig
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
authors.forename: Sandra
authors.initials: S
authors.lastname: Collette
authors.affiliation: Humanitas University and Nuclear Medicine Department, Humanitas Research Hospital, Milan, Italy.
authors.forename: Arturo
authors.initials: A
authors.lastname: Chiti
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism*; D002986:Clinical Trials as Topic / Q000379:methods*; D004608:Eligibility Determination; D006801:Humans; D057054:Molecular Imaging / Q000379:methods*; D009369:Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000628:therapy; D018579:Patient Selection; D011237:Predictive Value of Tests; D012107:Research Design; D012307:Risk Factors; D012308:Risk Management; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor