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

The SPIRIT 2013 (The Standard Protocol Items: Recommendations for Interventional Trials) 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 is a growing recognition that interventions involving artificial intelligence need to undergo rigorous, prospective evaluatio

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ethics.ai (9 September 2020), “Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI Extension,” evidence record 8842, https://ethics.ai/record/8842 (originally published by OpenAlex).

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