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Ethical considerations of prospective data collection for stereotactic arrhythmia radioablation (STAR): an overview
Chiara Crico1,2, Oliver Blanck3, Marcin Miszczyk4,5,6
1Legal Medicine and Bioethics, AUSL-IRCCS Reggio Emilia Hospital, Italy-Fondazione IRCCS Istituto Tumori di Milano, Milan, Italy.
Background:
Ventricular tachycardia (VT) is a life-threatening condition, and standard treatments are not suitable for many affected patients. Stereotactic arrhythmia radioablation (STAR) has emerged as a promising experimental last-resort treatment for patients with refractory VT, but it lacks clinical standardization. To address this issue, the STOPSTORM.eu consortium aims to collect data on patients treated with STAR via the development of a multicentric patient registry. The Ethics & Regulations Working Group (ERG) provides support addressing ethical and regulatory challenges.
Methods:
The ERG conducted a survey to assess how prospective data on STAR are collected at the partner centres and to explore potential ethical concerns. Responses were analysed to evaluate clinical trial approval processes, adherence to STOPSTORM guidelines, and emerging ethical issues.
Results:
Among the 28 partners, there were 13 interventional clinical trials-ongoing or concluded-across seven countries; centres without ongoing trials enrolled patients under compassionate use. Most trials were single arm, with few exceptions (a randomized trial and dose escalation studies). Most ethics committees approved STAR trials without major objections, but regulatory inconsistencies were observed, resulting in approval denial or delay. Ethical concerns included potential therapeutic misconception among patients, autonomy issues due to the vulnerability of VT patients, and inequities in access to STAR. The heterogeneity in trial designs, endpoints, and follow-up strategies among participating centres posed challenges for data standardization, but using a registry to collect data from multiple local clinical trials offers an innovative approach to overcoming logistical and financial barriers in research on rare diseases.
Conclusion:
Multicentric non-pharmaceutical trials on STAR may present ethical, regulatory, and organizational challenges. The open registry model facilitates large-scale data collection and supports future protocol standardization. However, greater intercentre collaboration and regulatory harmonization are needed to optimize STAR's integration into clinical practice while upholding ethical standards in patient care and research.
