Imaging-Based Methodologies for Evaluating Drugs in Clinical Trials

Clinical trials are a set of regulations and procedures designed to ensure the safety and efficacy of drugs intended for human use. Medical imaging has become an invaluable tool for drug evaluations, as it provides a noninvasive and rapid way of assessing treatment effects. For clinical trials with imaging, specific methods, regulations, and guidelines have been designed to ensure the safety and effectiveness of tested treatments However, as new therapies and technologies are developed, this framework of evaluation must be regularly updated and adapted to ensure that drug evaluations can continue to effectively assess the safety and efficacy of treatments. To improve the current evaluation framework, better methodologies should be implemented to not only benefit patients, but also to provide a more cost-effective and comprehensive understanding of new drugs.

In clinical trials with imaging, response criteria and imaging biomarkers are known to be incompletely qualified, some of them even reported to be suboptimal for new therapies. Notably, parts of image evaluation remain subjective, leading to reliability issues and additional costs. As Eroom's Law demonstrated, despite technological advancement, the cost of clinical trials is increasing, thus creating issues in the way the community discovers and develops new treatments. Although regulatory authorities use to update guidelines for evaluating drugs with imaging, there is still room for improving the reliability of assessments and their correlation to real patient endpoints. To meet these needs, new methods and technologies must be constantly proposed.

This Research Topic offers a comprehensive examination into how clinical trials can be executed, with imaging playing a primary role, and the resultant outcomes. Through this collection readers gain insight into topics such as clinical practice guidelines, clinical studies, randomized trials, protocols, the effects of different types and settings of clinical trials (e.g., reading paradigms, local reading versus Blinded Independent Central Reading), medical research methodologies, fundamentals of clinical trial monitoring, the different phases of the drug development process, fundamentals of site management, and statistical concepts for clinical research. Special attention is given to the evaluation of response criteria performance, particularly their robustness.

Please note that manuscripts consisting solely of bioinformatics, computational analysis, or predictions of public databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) will not be accepted in any of the sections of Frontiers in Oncology.