Children's medicine clinical trials have not broken 
 
 
The 2015-01-09 07:55:51 
 
 
Source: health 

 
Our correspondent Qiao Ning 

    Research shows that children's drugs in our country are facing severe challenges. 15 of the pediatric drugs used in tertiary hospital, manual label accounted for only 47.3% of the usage and dosage; A large children's hospital of manual medicine orders accounted for 53%. Hides behind the drug use, pediatric drug clinical trials research is weak this thorny problem.
 
    In the recently held the sixth tailored on children and children use safety peak BBS, ShenKun ling, vice President of the Beijing children's hospital of pediatrics experts point out that crack pediatric drug clinical trials, needs to cross obstacles.
 
    The clinical test units is difficult to meet the demand
 
    In the 1980 s, our country started pediatric pharmacological bases; From 1983 to 1990, approved by the ministry of health has 35 pediatric clinical pharmacology base; As of October 2014, the country contains a total of 65 pediatric professional administration of medical institutions by state food and drug supervision and administration institution decides that the clinical trials.
 
    "From a professional, medical resources and the number of patients in pediatrics, children's hospital than general hospital is more advantage in pediatric drug clinical trials, but a smaller number of the clinical trial institution decides that the children's hospital." ShenKun ling is introduced, by the end of 2011, a total of 79 children nationwide specialized subject hospital, including clinical trial institution decides that the only 12.
 
    Pediatric drug clinical trial on the number of professional distribution. According to statistics, obtain the clinical trial institution decides that the hospital, mostly in the breathing, pediatrics of traditional Chinese medicine, blood disease, kidney disease and other professional to carry out pediatric drug clinical trials, and difficult to satisfy the basic requirement of multicenter pediatric drug clinical trials.
 
    Nankai university school of law professor Song Hualin advice, our country can draw lessons from Occident developed countries through institutional barriers, the successful experience of cooperation to carry out the test. "In the 1990 s, European and American developed countries based on cooperation between institutions and the network technology, gradually formed the pediatric research collaboration. The pediatric clinical research unit network (PPRU) was established by the us national institutes of health, has realized the 13 access resources of pharmacological research institute of pediatrics, has about 177000 hospitalized patients every year, and more than 2 million outpatient resources, can be carried out stage Ⅰ to Ⅳ clinical pharmacology experiment."
 
    Ethics committee is not independent authority
 
    Pediatric drug clinical trials, child subjects interests are not violated shall in the first place. As children's interests "patron saint" ethics committee, shall not be affected by interference or clinical trial organizations and practitioners. But Shanghai children's medical center affiliated to Shanghai jiaotong university school of medicine, secretary of the party committee, deputy director jiang fan say: "children's rare drug clinical trial project, hospital leaders and pediatric cherish very much. Once the ethics committee of clinical trial project requirements or objection, it is likely to cause project rebound."
 
    "In addition, the ethics committee review clinical trial project, need to relevant departments and experts to provide technical support and professional advice. But if the experts belongs to the department of clinical trials, it is difficult to give independent opinions." Under this reality, jiang fan, ethics committee should begin from the outside unit hire experts have no conflicts of interest, to maintain the independence of the ethics committee.
 
    "In a foreign country, the ethics committee director general by scholars as a professional, to ensure the independence and professionalism of ethical review. In the pediatric drug clinical trial institution in our country, scholars as a director of only 6.12% of the time." State drug administration of the food and drug, director of the center for audit inspection Shen Yugong mentioned in 2013 led to carry out a national research, said the research involves the 49 pediatric clinical trials with the qualification of medical institutions, 70% by the hospital, director of the ethics committee of top managers (the party secretary, President, secretary of the commission for discipline inspection), 14.28% by scholars and experts or retirement institute leader and 4.08% by the middle managers.
 
    Absence of laws and regulations and guidelines
 
    "Ethical committee and clinical departments all hope in the process of conducting clinical trials, utmost ground to protect the interests of the child subjects, but sometimes really don't know what to do." Jiang fan, points out that the absence of laws, regulations and technical guidelines, pediatric drug clinical trials to owe specification.
 
    Abroad, pediatric drug clinical trial system is relatively sound laws and regulations. The United States has the pediatric trials fair laws such as the six pediatric drug clinical trials involving the laws and regulations, Japan has at least four. And our country since the 1993 years since the first children's drug clinical study, were not issued a special regulations. Only 2003 in drug clinical trials and the quality control standard requirements, child subjects must obtain the consent of its legal guardians of informed consent and signed consent form, the children can make agreed to participate in the research of decision, must obtain the consent of its consent. But Song Hualin think this requirement is not strong maneuverability.
 
    Pediatric drug use is a principle of clinical trial, avoid repeated trials, reduce test risk. "Our pediatric drug clinical trial data transparency is not high, lead to this principle is difficult to perform." Song Hualin suggested that our country can choose in the state drug administration or drug approval agency web site, published information on children has approved for clinical trials, including the test results (including the unfavorable results), the results of clinical trials and the comprehensive evaluation, etc. Researchers not only convenient to query information about similar clinical trials, avoid the repetition of the same design flaw, also provide new drugs for clinical doctors, sick children and parents research information, at the same time promoting child the importance of clinical trials, in order to recruit more participants.