Analysis On Key Points And Preventive Measures Of Clinical Trial Disputes In China

Objectives:The purpose of this study is to fully understand the current situation of clinical trial disputes in China and the reasons that may lead to clinical trial disputes in the actual process,and to propose corresponding preventive measures to guide the participants of clinical trials in the future to avoid the occurrence of corresponding problems in actual operation.And strengthen the awareness of all parties on the risk points arising from clinical trial disputes and their rights and obligations,so as to safeguard the rights and interests of all parties and prevent disputes from occurring.Methods:By referring to the cases on clinical trial disputes published by China Judgements Online,relevant literature and magazine media from 2000 to 2021,and combining with relevant laws,regulations and literature,this paper analyzes and summarizes the subjects and causes of clinical trial disputes from various dimensions and perspectives in the process of clinical trial.A questionnaire was designed and issued,and multiple response analysis method was used to investigate the opinions and suggestions of relevant personnel in clinical research on the key points of clinical trial disputes in China and corresponding preventive measures,so as to understand the current situation and related problems of clinical trial disputes in China.Results:1.Case collection results: a total of 91 cases of clinical trial disputes were collected,including 81 cases of China Judgements Online,7 cases of related literatures and 3 cases of magazines and media.2.Case analysis results: clinical trial disputes in China are mainly between subjects,study sites and sponsors,and between sponsors and CRO.Among them,the subjects’ disputes can be divided into informed consent disputes(41.4%),personal injury disputes(55.7%)and others(2.9%).The main reasons for the disputes were that the investigators did not carry out the informed consent process to the subjects(20.7%),the subjects did not fully understand the nature of the trial(20.7%),the subjects did not give their own informed consent(13.8%),and the subjects were inductively informed in the process of informed consent(34.8%).The injury of subjects in the course of the trial can be divided into clinical study related(25.6%),the investigator’s own fault(25.6%)or the subject’s own reason(49.8%).The reason for the disputes is that the subjects failed to receive timely and effective economic compensation after the damages occurred.The disputes between the sponsors and CRO were mainly caused by CRO,such as lack of corresponding technical ability(37.8%),slow progress of clinical trial project(28.4%),serious problems in the quality of clinical trials(24.3%),lack of partnership management skills(6.8%)and others(2.7%).3.Questionnaire analysis results: a total of 270 questionnaires were distributed,254 were recovered,and 208 were valid.The effective questionnaire showed that 1/3 of clinical trial related personnel had disputes in practice,and the disputes of clinical trials in China were still dominated by the disputes of subjects(86.1%).At present,there are still many nonstandard operations in the process of the trial,such as not carrying out the informed consent process to the subjects(39.9%),subjects failed to fully understand the nature of the trial(72.6%),the subjects were inductively informed in the process of informed consent(49.5%),subjects with AE/SAE did not give appropriate medical treatment in time(48.1%),medical records were not standardized(36.5%),and subjects who violated the inclusion exclusion criteria were enrolled(74.1%).It is generally believed that the GCP and ethical awareness of investigators should be enhanced(79.8%),and the review and supervision measures of ethics committee should be strengthened(36.5%),gradually establishing electronic informed consent means(46.2%)are the effective measure to avoid the subjects’ informed consent disputes.The effective measures to avoid the disputes of subject damage were to strengthen the education and communication with the subjects or their families(47.1%),establish the mechanism of subject damage compensation(59.6%),strengthen the quality management of the trial process(31.7%)and improve the compensation category in the clinical trial contract(48.1%).For the sponsor and CRO,serious quality problems in clinical trial project(69.7%)and slow project progress(59.1%)are the main causes of disputes between the two parties.The sponsor can correctly select the appropriate CRO based on the cooperation resources and project experience(55.8%)and quality management system(53.4%).CRO can improve the satisfaction of sponsors by timely solving problems(70.2%),attaching importance to effective communication(53.4%),and attaching importance to schedule control(50.5%).Conclusion:In China,there are still many clinical trial disputes in the actual process,among which the informed consent disputes and subject damage disputes are mainly caused by the non-standard clinical trial process and the imperfect relevant system.Subjects’ informed disputes can be avoided by enhancing the investigators’ GCP and ethical awareness,strengthening the means of review and supervision by the ethics committee,gradually establishing electronic informed consent means and recording the special informed consent process.The disputes over the damage of the subjects can be avoided by perfecting legislation,strengthening the education and communication with the subjects or their family members,establishing the mechanism of compensation for the damage of the subjects,strengthening the quality management of the trial process and perfecting the compensation category in the clinical trial contract.Sponsors should properly screen suitable CRO and strengthen the supervision of CRO to reduce the risk of outsourcing clinical trial programs.CRO can promote the cooperation goal by improving the satisfaction of the sponsor.