Risk Prevention And Control Of Pregnant Women In Drug Clinical Trials

Drug clinical trial is an important segment for drug research coming to clinical application from laboratory.Drug clinical trial takes healthy human beings or some patients who have some disease as subjects to prove the safety and efficiency of the drug.There are certain uncertainty of the trail process and outcome,this kind of uncertainty will cause potential and real risks.Thus,regulating drug clinical trial,keeping to the minimum risks of the subjects,protecting the safety of the subjects at the greatest extent,protecting the subjects interests,will not only be the problems drug clinical trial trying to fix,but also a significant topic of ethical research.During drug clinical trial,it's very important to protect the vulnerable subjects' safety and maintain their interests.It is significant to protect the vulnerable subjects and protect their interests in the study of drug clinical trials.Because the vulnerable subjects,they share the same specialty and have their own characteristic.The vulnerable subjects,their lives and healthy are weak,they are critically ill patients,infants,pregnant women,lactating women,the elderly,etc.And it's quite urgent to make research of the pregnant women safety and interest protection.Since the implementing of the “two-children policy”,more and more women follow this policy and the demand for pregnant clinical drugs increases.Since the pregnant specific medicines are very few,the safety of pregnant specific medicine gains more concern.The key to increase specific medicines is to make a research of the pregnancy drugs.However,it's so difficult to study.The choke point of pregnancy drug research is the safety of the subjects.The human body test of pregnant women is an important segment of the pregnancy drug research.Pregnant subjects have more risks than others because of the uncertainty of drugs and specificity of the physical and mental.During the real operation of the pregnant subjects protect,pregnant drug clinical trial of ethical review should focus on decreasing subjects' risks,protecting their safety,which is also a problem need to be fixed by pregnant drug research.This thesis consists of four chapters.Chapter one,the necessity and urgency of pregnant women participate in the clinical trial of drug research.Chapter two,the author analyzes the particularity of the pregnant women as a vulnerable group and the particularity of the pregnant women's rights and interests.The legal provisions on protecting the rights and interests of pregnant women in some countries are compared.Chapter three,this paper expounds the important role of ethics and morality in preventing the risk of pregnant women.Draw lessons from the international common ethical principles,analysis of the characteristics of pregnant women in China to protect.Chapter four,the specific scheme for the protection of pregnant women: the governments should refine the relevant laws and regulations to standardize the clinical trials of pregnant women and safeguard their rights and interests.In order to prevent and control the risks of human trial in pregnant women drug research,it is suggested that the subjects should be limited to the pregnant women who are ill and carry out the 0 phase clinical trial of pregnant women drug research.The ethical review of pregnant women drug research should adhere to the principle of risk minimization,informed consent and reasonable compensation.Meanwhile,the ethical review should emphasize the tracing review.Risk prevention and control of pregnant women in clinical trials should form a joint force.