人工智能应用于临床试验的伦理问题分析及对策

Ethical analysis and countermeasures of artificial intelligence application in clinical trials

人工智能的发展日臻成熟,已经渗透到临床试验的各个领域,人工智能为临床试验带来了新的发展机遇。然而,人工智能应用于临床试验仍然处于探索阶段,面临很多伦理问题,包括数据质量导致的试验风险、数据监管带来的隐私保护以及数据授权与知情同意矛盾等。我们应该精准定位人工智能于临床试验的可实现应用并理解其现实的伦理问题,制定相应的应对策略以保障临床试验全过程性能的最大化改进,包括加强数据质量管理,降低临床试验风险;优化数据监管机制,保障数据安全和隐私;搭建数据授权平台,健全知情同意司法保护等。

The development of artificial intelligence is becoming more and more mature,and has penetrated into every field of clinical trials.Artificial intelligence has brought new development opportunities for clinical trials.However,the application of artificial intelligence in clinical trials is still in the exploratory stage,facing many ethical issues,including trial risk caused by data quality,privacy protection caused by data regulation,and contradiction between data authorization and informed consent.We should precisely position the realizable application of artificial intelligence in clinical trials,understand its practical ethical issues,and formulate corresponding coping strategies to ensure the maximum improvement of the whole process performance of clinical trials,including strengthening data quality management and reducing clinical trial risks;optimizing data monitoring mechanisms to ensure data security and privacy;building a data authorization platform and improving judicial protection of informed consent,etc.