中国的临床试验80％数据伪造

1mp4

老王卖麻花 发表于 2016-10-25 14:10
我的签名档，没有骂人。
【临床试验数据造假】这个是事实。

人家没有否定有小偷，于是你就可以说路上80%小偷？不承认的就是畜生？
你骗了人不许人说你骗子，你造了谣不许人说你谣狗。说你谣狗你就反强迫人说别人畜生。

1mp4

老王卖麻花 发表于 2016-10-25 14:25
2016年10月25日之前的发言，有些被版主屏蔽了，有些翻找也麻烦。
今天2016年10月25日，我响应版主号召， ...

搞笑，你意思今天没造谣所以之前造的就不算了？

1mp4

老王卖麻花 发表于 2016-10-25 14:25
2016年10月25日之前的发言，有些被版主屏蔽了，有些翻找也麻烦。
今天2016年10月25日，我响应版主号召， ...

还说我攻击你，你签名天天攻击，我说啥你都胡搅蛮缠，我都懒得理你

StephenW

CFDA disputes claim that 80% of Chinese trials faked data but admits serious problems
by Phil Taylor | Oct 24, 2016 8:05am


China's regulatory authority is challenging reports that 83% of trials have fabricated results, but the numbers still suggest the country has a big data-integrity problem.

Last year, the China Food and Drug Administration (CFDA) ordered companies behind 1,622 regulatory applications for new drugs--mainly generics--to carry out "self-examination on the authenticity, integrity and compliance of clinical trial data." The idea was to give them an opportunity to withdraw problematic filings and reapply after they'd ironed out problems with their data.

In June, reports showed that companies had pulled 1,193 applications, which led to "reports in some media that '80% of China’s clinical trial data are fraudulent'," according to a CFDA official, who insisted that those assertions "are not fact-based."

Some applications may have been yanked because of deliberate data fraud, the unnamed official said in a statement. But some may have been withdrawn for other reasons, the official insisted, citing problems that, while severe, don't constitute fakery.

For instance, some studies may not have complied with Good Clinical Practice (GCP), while others could have had incomplete data or failed to "demonstrate the safety and effectiveness for the drug in application," the statement said.

According to the CFDA numbers, 193 of the marketing applications were for products exempted from clinical trials, leaving 1,429 applications under scrutiny. The CFDA has been investigating the applications and--as of the end of September--said 117 had been verified and 30 rejected "due to defects with authenticity."

The CFDA says that accounts for about 2% of the total number of registration applications selected for self-examination and verification so far. When the audit was announced earlier this year, some industry observers said they believed up to half of all marketing applications in China could include forged data.

All told, "27 applications, as well as 11 clinical trial institutions and the [contract research organizations] suspected of providing fraudulent data have been investigated," the regulator's latest statement said.

Either way, it seems the self-examination exercise has revealed serious issues with clinical research in China. Even if the investigation reveals that deliberate falsification occurred in a minority of cases, the high rate of voluntary withdrawals is evidence that substandard clinical testing is a massive issue.

For its part, the CFDA said the self-audit program and crackdown on data fraud "aims at encouraging innovation and creating a favorable environment for fair competition in order to ensure the safety and effectiveness of the drug approved to the market."

CFDA director Bi Jingquan recently described falsified clinical data as a "cancer" on the development of Chinese-made medicines that threatened to undermine the credibility of the domestic drug industry.

Related Articles:
CFDA head says clinical trial problems a 'cancer' on the industry
China FDA wants signed internal audits on clinical trial applications this month
Corruption investigation into former head of China hospitals, clinical trials
Chinese regulators easing multi-region clinical trial hurdles

StephenW

CFDA争议声称，80％的中国试验伪造数据，但承认严重的问题
作者：Phil Taylor | Oct 24，2016 8:05 am


中国的监管机构对83％的试验取得了成果提出了具有挑战性的报告，但数据仍然表明该国存在大数据完整性问题。

去年，中国食品药品管理局（CFDA）下令公司对新药（主要是仿制药）的监管申请进行了1622次监管，对“临床试验数据的真实性，完整性和合规性”进行了自查。这个想法是给他们一个机会，在他们解决了他们的数据问题后，撤回有问题的文件并重新申请。

据一位CFDA官员称，6月份的报告显示，公司已经提交了1 193份申请，导致“一些媒体报道，”中国临床试验数据的80％是欺诈性的“，一位CFDA官员坚称这些说法”基于“。

这位匿名官员在一份声明中说，一些应用程序可能因为故意的数据欺诈而被打了。但有些人可能由于其他原因撤回，官员坚持，引用问题，虽然严重，不构成伪造。

例如，一些研究可能没有遵守良好临床实践（GCP），而其他研究可能有不完整的数据或未能“证明药物在应用中的安全性和有效性”。

根据国家食品药品监督管理总局的数据，193个营销申请是针对免于临床试验的产品，其中有1429份申请正在审议中。国家食品药品监督管理局一直在调查申请，截至9月底，117家已经通过验证，30家拒绝“由于真实性缺陷”。

国家食品药品监督管理总局说，到目前为止，被选为自我检查和核查的注册申请总数约占2％。当审计于今年早些时候公布时，一些业界观察人士表示，他们相信中国的一半营销应用程序可能包括伪造数据。

“所有的，”27个申请，以及11个临床试验机构和[合同研究组织]怀疑提供欺诈数据已经调查，“监管机构的最新声明说。

无论哪种方式，似乎自我审查工作揭示了中国临床研究的严重问题。即使调查显示在少数病例中发生了故意的伪造，高自愿撤回率的证据表明，不合格的临床试验是一个大问题。

CFDA表示，自我审计计划和打击数据欺诈“旨在鼓励创新，为公平竞争创造有利的环境，以确保药品批准市场的安全性和有效性。

国家食品药品监督管理总局局长Bi Jingquan最近将伪造的临床数据描述为对中药制剂开发的“癌症”，威胁破坏国内药品行业的可信性。

相关文章：
CFDA主管说临床试验问题是一个“癌症”的行业
中国FDA希望本月签署临床试验申请的内部审计
腐败调查前中国医院负责人，临床试验
中国监管机构放宽多区域临床试验障碍

1mp4

老王卖麻花 发表于 2016-10-25 14:35
史蒂芬大神出来主持公道了。
【临床试验数据造假泛滥】这个是摆在眼前的事实。
纠缠不清的诡辩之人，只能 ...

是CFDA说公道话打你脸了，你还贴上来
你造了谣不道歉，和偷了钱不还没啥区别