以患者为中心的临床试验的伦理审查挑战OA北大核心CSTPCD

Patient-centered clinical trials refer to clinical trials that take participant'needs as the starting point,regard participant as active participants,and take clinical values as the ultimate goals.This concept has become the core guiding ideology of current pharmaceutical research and development,and the model of the patient-centered clinical trial will gradually become the mainstream model of pharmaceutical research and development.Patient-centered clinical trials in China have challenges such as difficulty in changing the way of trial thinking and quality control,increased difficulty in participant'privacy protection,lack of training for all research parties,and unfair recruitment of research participants.Then suggestions were proposed for patient-centered clinical trials in China from three aspects,including relevant departments provide more policy support,sponsors and relevant third parties timely transform ideas of research and development,as well as researchers and research participants strengthen awareness.This paper also put forward the key points of ethical review of patient-centered clinical trials from 8 aspects,including the trial design that incorporated preference information on patients and took into account the assessment of clinical outcomes,protection of the safety and rights of research participants,recruitment based on the needs of research participants,acceptable informed consent,the rationality of selection of decentralssed clinical trials elements,privacy protection of research participants,training and education of researchers and research participants,and compensation and indemnity of research participants,so as to standardize the ethics review of patient-centered clinical trials and ensure the quality of patient-centered clinical trials.