Health Planning Commission: clinical research on immuno-cell therapy is medical _ charges for immune cell | | | news

Formal clinical trial volunteers needed a variety of conditions, are indispensable.

Legal evening news (reporters Fan Botao) recently, along with Wei Zexi event exposure, known as autologous immune cell therapy began to be concerned about.

On May 4, the State family planning Commission was held on regulating departments of medical institutions of health management and medical technology management teleconference, Conference reaffirmed the clinical study on autologous immune cell therapy techniques in accordance with the relevant provisions. This means that this technology is not used in clinical treatment, embrace the technology in patients with "treatment" is not valid.

The legal daily (app ID:fzwb_52165216) found, in accordance with the relevant provisions, if a hospital requires patients to participate in clinical studies, should not charge any fees, require patients to pay a certain amount of nutrients even compensation.

This impression with people that you want to use new therapies, new drugs to tens of thousands of Yuan spent thus far.

　　Authoritative press briefing

Clinical study on the treatment of autoimmune cells count

The morning of May 4, the State Department of Health Planning Commission concerning the regulation of medical institutions was held management and technical management of medical teleconference. The meeting proposed that medical institutions shall practice prohibiting rental or disguised rental Department and issued false medical advertising violations.

The teleconference was organized by provincial, municipal and county-level health and family planning medical HA responsible comrades and second-level hospital to attend. Meeting request medical institutions at all levels should further strengthen the sense of law practice, health family planning administrative departments at all levels should further strengthen the illegal medical practice of supervision and crackdown.

Meeting request medical institutions shall practice, prohibit the rental or leased departments in a disguised form, as well as publishing false medical advertising violations, further strengthen the management of medical technology clinical practice, conscientiously implement the National Health Commission on canceling class III medical technology clinical practice admittance documents relating to notice of the approval requirements.

The Conference reaffirmed that is not on the "limiting clinical application in medical technology (2015 version)" in the list of the first catalogue of class III medical technology clinical application allows other technologies (mainly refers to the treatment of autoimmune cells), in accordance with the relevant regulations of clinical research. This reporter has learned, class III medical technology is a major ethical problems, high risk, safety and effectiveness of standard clinical trials are needed to further validate and require the use of scarce resources and other circumstances, need to be strict control and management of the Administrative Department of public health medical technology.

Application third class medical technology of conditions is strictly, need submitted of material including: carried out the items medical technology of purpose, and meaning and implementation programme; the items medical technology of basic profile, including both at home and abroad application situation, and adapted card, and taboo card, and bad reaction, and technology route, and quality control measures, and effect judge standard, and assessment method, and other medical technology clinic same disease of risk, and effect, and costs and the course compared,; carried out the items medical technology has of conditions, including main technicians of practice industry registered situation, and Qualifications, curriculum vitae, medical equipment, facilities and other supporting conditions, risk assessment and contingency plan; medical ethics review of this body.

In many conditions under strict restrictions, currently there is no domestic medical institutions access to clinical applications.

The participants

Rigorous clinical research process informed

Real clinical studies the process?

Guo of the Hunan xiangya hospital three doctors have been involved in antiviral drugs in clinical trials, and through Twitter to recruit volunteers. He told reporters that it was his understanding that, after a drug invented, first tested on mice or other animals. After entering drug test link. Research Unit recruiting healthy volunteers as a reagent to test side effects.

After a drug test test is a clinical trial, patients with diseases related to need to find some, but more have finished clinical trials of drugs to enter the listed link.

A staff member participated in clinical trials of pharmaceutical companies also told reporters that due to the completion of a thorough report, the test conditions are very harsh. Even illness in patients, if others are not qualified, or even age were able to participate in the trial.

Her participation in the project, when Inquisition will ask doctors looking for qualified patients. Clear test uses, risks, and the consent of the patients consent, can begin to test. "Cannot call for similar patients studied. ”

Legal evening (micro-letter ID:fzwb_52165216) reporter see, Guo doctor in online released of anti-virus drug try drug member recruitment conditions in on mentioned, need 24 name male by try who, drug for oral tablets, requirements age in 18 age to 29 age Zhijian, weight to is greater than is equal to 50 kg, a months within not participate in other any test, and 14 days within no medication history, 3 months within no blood history.

Medical University Cancer Hospital in China posted a couple of patient recruitment advertising, our reporter saw, not only to meet the preliminary requirements such as age, severity, and contact the doctor in advance, participation, including through further checks to confirm compliance with test conditions.

　　Subjects about

Do not pay money and subsidies

Ads in multiple sets of clinical research volunteers, recruited journalists noted that all recruitment ads with similar characteristics.

For example, in addition to the types of patients demanding things, one of which is clearly know your patients will participate in clinical trials. Clearly knows that this test might be valid or invalid. Which is reflected by the current patient of armed police hospital-related sections of the so-called "treatment", "a high success rate" is obvious.

Guo also told reporters that the research unit recruiting healthy volunteers as a reagent, to sign an informed agreement before the drug test, to inform the risk of drugs.

In addition, the reporter found that almost all recruitment advertisement mentioned "free" two words. Including exemption of methods for treatment of the pilot project cost, and the corresponding examination, hospitalization, and so on.

Among them, there are some ads suggested that will provide nutritional supplements for patients involved in the tests, subsidies, and so on. For example, Dr Guo project, will provide nutrition of 1400 Yuan fee for the drug test.

By late journalist inquiry found that this policy of free clinical trial is guaranteed.

Journalists at the National Health Commission website on the "clinical trials" documents also show that clinical trial subjects were not allowed to charge a fee. Among them, the administrative measures for stem cell clinical trial (trial) clearly defined, phase I, II and phase III stem cell clinical trials of experimental study on stages of belong in the human body, not to participants free of charge.

The seventh section of the clinical trials of medical devices regulations, medical device clinical trials subjects were not allowed to charge a fee.

Article 29th of drug clinical trial practice also explicitly demanded that the researchers should be agreed with the sponsor the costs associated with clinical trials, and stated in the contract. Researchers report in the clinical trial process, shall not be charged to the participants testing the cost of medication.

　Related links

Guangdong hospitals have stopped cell immunotherapy

According to media reports, on the national health planning Committee reiterates its demand for clinical research on autologous immune cell therapy techniques in accordance with the relevant provisions at the same time, Guangdong Province, several hospitals have confirmed to the media, President, national health planning emergency notifications, hospital has suspended clinical application of immune therapy.

Integrated Chinese and Western medicine hospital, Southern Medical University said Luo Rongcheng, 4th, the Academy had been suspended, including d IK immune cell therapy in clinical application.

Deputy Director of the Cancer Center of Sun Yat-sen University Professor Zeng Musheng also said that the Center has been in accordance with the national health planning Commission to stop clinical therapies.

Zeng Musheng said immunotherapy is a very promising treatment, the hospital has been committed to promoting the standardization of biological therapy management. He said hope authorities together with the experts in the field of introduction of standard and suitable administrative measures, promote the development of cancer immunotherapy, and protect the interests of patients.

Previously, Foshan have halted hospital treatment of autoimmune cells and said it was to the city's medical organizations, technology and advertising inventory management such as.

Text/reporter Fan Botao

Responsible editor: Zheng Hanxing

Article keywords:
Immune cell technology clinical

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Legal evening news

卫计委：免疫细胞治疗属临床研究 不可收费|免疫细胞|技术|医疗_新闻资讯

正规临床试验招募志愿者需要多种条件，缺一不可。

　　法制晚报讯（记者 范博韬）近日，随着魏则西事件被曝光，一种名为自体免疫细胞治疗技术开始受到关注。

　　5月4日，国家卫生计生委召开了关于规范医疗机构科室管理和医疗技术管理工作的电视电话会议，会议重申，自体免疫细胞治疗技术按照临床研究的相关规定执行。这意味着这种技术不能用于临床治疗，患者接受这种技术“治疗”是不合法的。

　　《法制晚报》（微信ID：fzwb_52165216）记者发现，按照相关规定，如果医院需要患者参与临床研究，就不应该收取任何费用，甚至还需要支付患者一定的营养补偿。

　　这与人们印象中要使用新疗法、新药品动辄几万元的花费相差甚远。

　　权威发布　

　　自体免疫细胞治疗算临床研究

　　5月4日上午，国家卫计委召开了关于规范医疗机构科室管理和医疗技术管理工作的电视电话会议。会议提出，医疗机构必须依法执业，禁止出租或变相出租科室及发布虚假医疗广告等违法违规行为。

　　此次电视电话会议由省、市、县三级卫生计生委医政医管负责同志及二级以上医院院长参加。会议要求各级医疗机构要进一步强化依法执业意识，各级卫生计生行政部门要进一步加强对违规医疗行为的监管和打击力度。

　　会议要求，医疗机构必须依法执业，禁止出租或变相出租科室，以及发布虚假医疗广告等违法违规行为；进一步加强医疗技术临床应用管理，认真落实《国家卫生计生委关于取消第三类医疗技术临床应用准入审批有关工作的通知》文件的要求。

　　会议重申，未在“限制临床应用的医疗技术（2015版）”名单内的《首批允许临床应用的第三类医疗技术目录》其他在列技术（主要指自体免疫细胞治疗技术等），按照临床研究的相关规定执行。记者了解到，第三类医疗技术是指具有涉及重大伦理问题、高风险、安全性、有效性尚需经规范的临床试验研究进一步验证，需要使用稀缺资源等情形之一的，需要卫生行政部门加以严格控制管理的医疗技术。

　　申请第三类医疗技术的条件极为严格，需要递交的材料包括：开展该项医疗技术的目的、意义和实施方案；该项医疗技术的基本概况，包括国内外应用情况、适应证、禁忌证、不良反应、技术路线、质量控制措施、疗效判定标准、评估方法，与其他医疗技术诊疗同种疾病的风险、疗效、费用及疗程比较等；开展该项医疗技术具备的条件，包括主要技术人员的执业注册情况、资质、相关履历，医疗机构的设备、设施、其他辅助条件、风险评估及应急预案；本机构医学伦理审查报告。

　　在诸多条件的严格限制下，目前国内尚无一家医疗机构获得临床应用。

　　参与者讲述　

　　临床研究过程严谨 患者知情

　　真正的临床研究有怎样的过程？

　　湖南湘雅三医院的郭医生曾参与过抗病毒药物临床试验，并通过微博招募志愿者。他告诉记者，据他了解，一种药物发明出来后，首先要在小白鼠或者其他动物身上进行试验。之后会进入到试药环节。研究单位招聘身体健康的志愿者作为试药员，检验副作用。

　　经过试药员试验后才是临床试验，这时候需要找一些相关疾病的患者，但是条件比较多，临床试验完毕之后药物才能进入上市的环节。

　　一名参与过药品临床试验的医药公司的工作人员也告诉记者，因为要完成详尽的报告，对试验者的条件要求非常苛刻。即便是对应病症的病人，如果其他指标不合格，甚至年龄不符，都不能参加试验。

　　在她参与的项目中，会请门诊医生配合在问诊时寻找符合要求的患者。明确说明试验用途、风险，并征得患者同意后，才能开始试验。“不可能把类似病人叫过来进行试验研究。”

　　法制晚报（微信ID：fzwb_52165216）记者看到，郭医生在网上发布的抗病毒药物试药员招募条件里就提到，需要24名男性受试者，药物为口服片剂，要求年龄在18岁至29岁之间，体重要大于等于50公斤，一个月之内未参加其他任何试验，并且14天内无服药史，3个月内无献血史。

　　在中国医科大学肿瘤医院贴出的几张患者招募广告中记者看到，患者不仅要满足年龄、病情等初步要求，还要提前与医生联系，通过检查等方式进一步确认是否符合试验参与条件。

　　受试者讲述　

　　不交钱 还有补贴

　　在多组招募临床研究志愿者的广告中记者注意到，所有的招募广告都具备类似的特征。

　　比如，除了对病人的类型要求严格外，其中一条便是患者会明确知道自己参与的是临床试验。清楚地知道，这种实试验可能有效也可能无效。这与目前患者所反映的武警二院相关科室所谓“治疗”、“成功率高”等说法有明显区别。

　　郭医生也告诉记者，研究单位招聘身体健康的志愿者作为试药员，在试药之前还要签订一个告知协议，对药物可能带来的风险进行告知。

　　此外，记者发现，几乎所有招募广告都提到了“免费”两个字。其中包括免除接受该试验项目的方法进行治疗产生的药费，以及相应的检查、住院费等等。

　　其中，还有部分广告提出，会为参与试验的患者提供营养补助、补贴等等。例如，郭医生的项目，就会为试药员提供1400元的营养费。

　　法晚记者查询发现，这种免费临床试验是有政策保障的。

　　记者在国家卫生计生委网站上查询到关于“临床试验”的相关文件也显示，临床试验不得向受试者收取费用。其中，《干细胞临床试验研究管理办法（试行）》明确规定，I期、II期和III期干细胞临床试验研究均属于在人体的试验研究阶段，不得向受试者收取费用。

　　《医疗器械临床试验规定》第七条提出，医疗器械临床试验不得向受试者收取费用。

　　《药物临床试验质量管理规范》第二十九条也明确要求，研究者应与申办者商定有关临床试验的费用，并在合同中写明。研究者在临床试验过程中，不得向受试者收取试验用药所需的费用。

　　相关链接

　　广东多家医院已叫停细胞免疫疗法

　　据媒体报道，就在国家卫计委重申要求自体免疫细胞治疗技术按照临床研究的相关规定执行的同时，广东省多家三甲医院院长也向媒体证实，接国家卫计委紧急通知，医院已暂停细胞免疫疗法的临床应用。

　　南方医科大学中西医结合医院院长罗荣城称，4日开始，该院已经暂停包括D C -C IK在内的免疫细胞疗法临床应用。

　　中山大学肿瘤防治中心副院长曾木圣教授也称，该中心已经按照国家卫计委要求停止相关疗法的临床应用。

　　曾木圣教授认为，免疫治疗是非常有前途的治疗手段，医院一直致力于推动生物治疗规范化的管理。他表示，希望主管部门与领域专家一道出台规范合理的管理办法，促进肿瘤免疫治疗的健康发展，并确实保护好患者的利益。

　　此前，佛山也已叫停医院开展自体免疫细胞治疗技术，并称正对全市医疗机构、技术及广告等管理情况进行清查。

　　文/记者 范博韬

责任编辑：郑汉星

文章关键词：
免疫细胞 技术 医疗 临床

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