| The medical device clinical trial is a process in which the safety and efficacy of a new medical device that needs to register and market is being verified in the normal condition in certified institutions of medical device clinical trials.The process includes: protocol designing,implementing,monitoring,auditing,inspecting,data collecting,recording,analysing and reporting and so on.The purpose of clinical trials is to verify the safety and efficacy of a new medical device and provide scientific evidence to help a new medical device register.Ethical problems of protocol designing and implementing in medical device clinical trials have something to do with the safety and rights of subjects.This study uses qualitative analysis and quantitative analysis,theoretical analysis and empirical analysis to explore ethical problems of protocol designing and implementing in medical device clinical trials.The study lasts one and a half years.The objects of this study are 21 medical device clinical trials(including 6 in vitro diagnostic reagents)that I accessed when I did quality control in a certain hospital from August 2016 to January 2018.This study analyses the following issues.In the protocol designing part,the problems of choosing an inappopriate primary endpoint,choosing or handling control groups improperly,selecting an unbefitting type of trial design and using a third party testing method more frenquently can have a harmful effect on subjects.Implementing the protocol is a strict and well-organized process,and in the process,ethical issues are complicated and obvious.It includes that informed consent forms signed by subjects’ statutory agents can’t protect the right of informed consent of subjects;the trial will lose justice when subjects are treated against the randomization;the use of clinical residual samples has the problem of authenticity;problems in operation makes clinical curative effect evaluation unscientific;there are some ethical problems in adverse events and serious adverse events;there are some ethical problems about the cost of trials and the expenses of compensation for subjects;the clinical trial is failed because of statistical errors.Statistical methods: descriptive statistics,Fisher’s exact test.Results show that the development of medical device clinical trials is getting better and better and is going toward to a scientific and normative direction,especially after the most strict data inspection of clinical trials organized by CFDA from 2015.However,some medical device clinical trials still have a lot of ethical issues,which have a close connection with the safety and rights of subjects,making us rethink profoundly.According to this conclusion,we put forward the following suggestions: discussing the protocol jointly to make sure that the protocol designing is scientific and ethical;strengthening the supervision function of ethics committee;strengthening monitoring,audit and inspection from diffierent institutions and organizations;perfecting laws and regulations of medical device clinical trials;improving the sense of ethics of clinical trial researchers to protect the safety and rights of subjects radically. |
