Transforming Clinical Trials in Skin Cancer Research: Exploring the Potential of Flexible and Innovative Designs

Abstract

Over the past 2 decades, innovations in trial design have significantly advanced the field of clinical research. Methodological developments, such as adaptive designs, basket trials, umbrella trials, and platform trials, along with technological advancements such as virtual studies have proven effective in tackling complex research questions and managing resource constraints. These approaches enable prospectively planned modifications to trial designs and facilitate addressing multiple research questions within a single infrastructure, with technological advancements such as virtual studies enhancing accessibility, efficiency, and patient engagement. These designs can also integrate biomarker information or risk-prediction scores to enhance the efficacy of future clinical trials, through a better selection of patients. Despite the appealing flexibility of these new approaches, their adoption varies across different therapeutic domains. We explored the translation and relevance of these innovative approaches in skin cancer research with a focus on melanoma. An overview of existing melanoma clinical trials that incorporate innovative features as well as other potential studies currently under consideration are discussed. This paper highlights the potential of innovative approaches to optimize melanoma trials under the constraints of limited patient and financial resources. The presented ideas can easily be extended to other nonmelanoma skin cancer trials.