I believe many people will answer in the affirmative. Studied at the Beijing Second Foreign Language University, has a small core (a pseudonym) is no exception. However, she saw the notice of the inscription is when recruiting hesitated. This is the recruitment by a pharmaceutical company Examination of those ads, targeting the recruitment of healthy college students. "This is What is the difference and find mice?" Has a small core could not help saying. Without the protection of the laws and regulations, participate in clinical drug trials of subjects, may not be as concerned by the animal protection organization mice. Recently, the subjects of the first formal protection system at Peking University Established, including data safety monitoring committee, the Biosafety Committee, Office of Research Integrity of conflict of interest with other agencies. "Subjects protection system can better respect and safeguard fundamental rights as human subjects." Peking University, Biomedical Ethics Committee chairman, Medical Ethics, Professor Cong Yali said. Each year more than 800 kinds of new drugs for human trials, involving about 50 million people in the crowd "Everyone can become subjects." Cong Yali explains the subjects establish working system in mind. Engaged in the protection of the subjects in the past 10 years, professor seems that as long as the participants involved in the study. Including not only volunteer to participate in clinical trials, including patient pressure, because the reasons for adding subjects The ranks of patients. Cong Yali explained that many patients think that if the attending physician not to participate in clinical trials sponsored, "he will certainly not good government of my illness." In general, new drugs must go through basic research, animal testing and human clinical trials and so forth procedures, can be listed. In clinical trials, the researchers through active intervention or no intervention means, in Subjects who were new drugs, treatments and other tests, analyzing data, the symptoms observed, access to relevant information. In recent years, China's surge of drug clinical trial program, a study involving dozens of subjects varies, as many as tens of thousands. Data show that China has 800 kinds of drugs each year for human trials, involving about 50 people Million. On the subject, the public has a very image of the title - "medicine man." Starting from the middle of last century, along with medical and behavioral research found that many problems continue to protect subjects of medical research increasingly into public view. Including most notably the United States "Tuskegee Syphilis Experiment" . Since 1932, the U.S. Public Health Service for free treatment of syphilis in the name of the 500 without the knowledge of the African American as a test object, the secret of syphilis on the human body. In fact, these subjects did not have To any treatment. Until 1972, this project was terminated by the media exposure. At that time, participating in the trial, there were 28 patients who died directly of syphilis, about 100 people died of complications due to syphilis, the wife was infected 40 people, 19 children infected with syphilis at birth. Published in 1964, "Declaration of Helsinki" is considered the cornerstone of ethical clinical research ethics. Which states: "Medical research is only in the study population can benefit from when the results of the study be conducted." Institute of Clinical Pharmacology, Peking University Lu Yuan, told reporters in China, protection of subjects 90 years from the last century has just started, everything is "not mature enough." Previously, only the Bioethics Committee undertake the important task of protecting subjects. At present, only the larger medical schools, research institutions and the top three hospitals, only to set a special Council on Bioethics. In accordance with the Requirements before the start of clinical trials, the study group in advance where the bodies to the Bioethics Committee submitted their report. Studies, including research methods, purpose, number of other subjects. Tests must be carried out every step Detailed plans, including the composition of medicines, tests and changes in pharmaceutical doses. Bioethics Committee agreed only after research programs, clinical trials before they can formally. "But the role of the Committee on Bioethics is limited." Cong Yali said, "protection is not only not enough, even some anticlimactic." She acknowledged that the lack of effective supervision, clinical trials will be some problems. For example, some research group will study the steps without change; test data or even suspicion of fraud exists; and signed subjects and study groups "Informed consent" at the crucial moment can not protect the role of subjects. Only a few members to adhere to the continuing ethics review, but the control of the research process is still "weak." Subjects without any protection of the uneven bars like the athletes Under such circumstances, the subjects had a small core, as the metaphor has become uneven bars athletes, in the absence of any protection measures to complete a variety of difficult moves. A medicine man said to the media, ask the doctor before the test if their side effects, the other side to comfort him, "without any complications and side effects" that can "confidently with the test." Later, he found himself nose sometimes Bleeding, and often sweating, a little bit out of breath movement, he knew his medication with anti-coagulation. This improvement in subjects protection system is difficult to imagine circumstances. For example, subjects were eligible for the United States has a stringent audit requirements. If you fail to meet a study group of subjects, the test results will Will not be recognized. New drug application for marketing authorization, it will be rejected. Most research institutions will have a readily available list of volunteers. In addition, the researchers were able to put in the outpatient office or operating room notice, but like "4 days pocketed 3,000 yuan," like the ad is serious Li prohibited. However, subjects protection system is not perfect, China constitutes a very complex subjects, vocational subjects, college students and even medical staff are an important part. Some traders smell great commercial interests, a subject, intermediary agencies and test the food chain gradually. According to a small core has provided contact information, the China Youth Daily reporter found the recruitment of students in subjects Liu Yue between (a pseudonym). He is the Haidian Area with college graduates. Liu Yue said in private, some of these intermediaries to register the company's way, more or individuals. Some "intermediate reagent" itself with the hospital, head of the study group are familiar with the relationship they have stable Subjects of resources in the short term for individual research projects, quickly find the subjects. Through the "matchmaking", "test drug agency" often charge a commission, usually paid 25% of the subjects to 30%, sometimes even higher Up to 40%. According to rough estimates, only in Beijing, there are nearly 7,000 professional volunteers shuttling between major hospitals. "Vocational subjects not reflect the true efficacy of drugs." Anonymity of the Union Hospital clinical experts said. He said pharmaceutical companies, research institutions tend to use college students for medical tests . Because students generally do not have bad habits, and cultural qualities, both physical health status more in line with requirements. Cong Yali told reporters that health care is of special subjects. They possess the necessary professional knowledge, clinical trials, the symptoms can be effectively controlled. Therefore, in Phase I trials of new drugs, the health care Staff often join. In one test, a doctor by changing the dosage, to test new drugs on the clinical response in the human body, a lower safety factor, the greater the danger of the human body. "System to protect the legitimate interests of the subjects very tight." She paused said. 2008, 10 new drugs approved by the United States, no one subject is American In 2003, 34 AIDS patients in the hospital to the altar a drug test, at 6-month observation period, 4 people were killed. Two years later, one of these patients, the project unit to the ethical review committee issued a public Open letter, asked the Committee to review the drug trials ethical and legal issues involved and proposed to all involved in drug trials were treated with living expenses, lost income, expenses and these payments of the grant request. Later, after "Chinese New News Weekly, "the survey, this study was not approved by the State Food and Drug Administration. This drug is only from the United States and Mexico in Bulgaria completed human trials. Whether the incident led multinational pharmaceutical companies in China should try to set the threshold of the drugs controversy. According to the U.S. Department of Health and Human Services report released in 2008 in the United States, 80% of approved drugs for human testing in a foreign country Experience, and all those involved in human trials in 78% of subjects recruited in foreign countries. Which approved 10 new drugs to test in a foreign country completely, no one subject is American. Some experts believe that China's fundamental aim pharmaceutical giants in Europe and America because of high risk drug trial, and even clinical trials, retrospective accident 20 years ago, the amount of compensation has reached tens of millions of dollars. In contrast, earlier AIDS patients referred to claims actually only 10 yuan a day of missed work subsidies, also suggested that a hen or a pound of eggs, like standards. Is gratifying that in recent years, domestic protection for the subjects of concern about the increasingly high. In early 2007, the Ministry of Health issued a "biomedical research involving human ethics review (Trial)", designed to regulate Biomedical research involving human and related technology, the protection of human life and health, human dignity, respect and protect the legitimate rights and interests of human subjects. Starting from March this year, and some researchers Cong Yali, China's first subjects into the working system of the preparatory work. "Peking University, working system subjects learned the advanced experience of home and abroad, in this based on the design is completed." Cong Yali said that the work system consists of nearly 50 staff members, who have specialized HRP experience. Peking University Health Science Center, said deputy Renfang Wei Kong, Beijing subjects protection system will provide training for researchers, ethical review of research programs, the process of ethical oversight of research on the future clinical Bed capacity and scientific leadership training, maintaining the integrity of scientific research, etc., to provide comprehensive protection subjects. A staff member said privately that they hope the subjects protection system, and really help "those in a weak position" in the subject. Maybe soon, he will no longer be a small core column in the school publicity, and found that her "shock" ads. Recruitment of subjects, not "do business", not "looking for mice."

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