Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI

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ethics.ai (1 September 2020), “Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension,” evidence record 8738, https://ethics.ai/record/8738 (originally published by OpenAlex).

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