Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens' Jury for an 'Informed...

Area of Science:

• Oncology
• Radiotherapy
• Health Informatics
• Bioethics

Background:

• Real-world data (RWD) complements randomized controlled trial (RCT) data in radiotherapy development.
• Routinely collected RWD offers insights into standard cancer care but raises consent and ethical questions.
• Patient and public perspectives are crucial for the ethical use of RWD in clinical practice.

Purpose of the Study:

• To explore patient, carer, and public views on consent for RWD use in lung cancer radiotherapy.
• To determine preferred communication strategies for RWD utilization in clinical settings.
• To inform ethical guidelines for RWD consent processes in cancer care.

Main Methods:

• A two-day citizens' jury engaged patients, carers, and the public.
• Individual views were collected via questionnaires.
• Group discussions facilitated dialogue on consent preferences for RWD use.

Main Results:

• The jury favored an informed opt-out consent model for RWD use.
• Communication regarding RWD consent and use should be accessible, clear, and varied.
• Emphasis was placed on autonomy, transparency, and proportionate risk in consent processes.

Conclusions:

• Informed opt-out consent is acceptable for RWD use in radiotherapy research.
• Transparent and accessible communication is vital for patient trust and engagement.
• Ethical RWD data use requires processes respecting patient autonomy and proportionality.