Introduction: The recent increased interest in trials for neurosurgical oncology marks a significant advancement in the systematic evaluation of neurosurgical interventions in neuro-oncology. Randomized controlled trials present the gold standard for evidence collection, but the concept of randomization contains numerous ethical considerations. In this scoping review, we aim to characterize the landscape of ethical challenges in randomization for neurosurgical oncology trials, highlight gaps in the literature, and delineate best practices for approaching randomization in these trials, including the role of alternative study designs.
Methods: A scoping review was conducted using the PubMed, Embase, and Scopus databases. Titles and abstracts were screened for relevance. Studies meeting prespecified inclusion criteria underwent full text review. Relevant data were extracted.
Results: Of 546 resultant articles, 20 were included. Seven (35%) studies focused on limitations of RCTs, six (30%) on utility of randomization, 4 (20%) on alternative designs, and 3 (15%) on informed consent. Randomization has intrinsic challenges but also poses extrinsic ethical issues due to the practical implementation of RCTs in neurosurgical oncology, including unrepresentative study populations, uncertainty regarding equipoise, and the inability to attain truly informed consent. Alternative study designs include preliminary prospective cohort studies with specific properties (IDEAL 2B studies), on/off studies, seamless phase II/III trials, window-of-opportunity trials, and adaptive randomization models.
Conclusion : Randomization in neurosurgical oncology RCTs is ethically charged, requiring consideration of when to utilize RCTs. When RCTs are the most useful study design, proper design and implementation may mitigate these ethical challenges. In other cases, using alternative study designs may advance research while safeguarding ethical priorities.
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