欧盟将通过立法要求公开临床试验结果

            欧盟将通过立法要求公开临床试验结果
1 Q; R( t, N  Y' `* Z; q1 n- k近日，欧洲议会批准新的措施，强制研究者提供他们的临床试验结果，并对不符合要求的试验予以罚款。议员们以压倒多数的投票通过新的《欧盟临床试验法规》，新的法规要求制药企业及学术研究者发布他们所有的欧洲临床试验结果，包括阴性研究结果。

) X' S0 K- X$ e2 y                               
登录/注册后可看大图

这项法规有望于2016年生效，该法规也将促进临床试验的跨界合作，有利于改善罕见疾病的研究。这次立法由英国的Glenis Willmott主导，她表示对议会同伴的支持感到高兴。

“这一法规将使临床试验更加透明，为患者带来希望。新的法律使得跨界临床试验更容易实施，也将为欧洲数百万的罕见病患者带来希望。”

这次变更将简化报告程序，授权欧盟委员会进行检查，给成员国固定期限以对临床试验申办者的产品申报资料做出响应。为了增加临床试验透明度，上市许可一旦获得授权或上市许可申请被撤回，详细的总结（包括全部的临床研究报告）要在欧盟公共数据库中发布。

欧洲制药企业团体EFPIA表示，新的临床试验法规将“通过单一提交及总体的流水线评价程序帮助欧洲培养一种更加和谐的临床试验途径”。该团体还补充说：“EFPIA也欢迎立法在提高透明度的同时，尊重保护个体患者数据及商业机密信息的需要。”

但该团体还补充说，“尊重病人隐私及监管决策的完整性，激励企业在生物医学研究领域进行长期投资”是至关重要的。

Europe votes for greater clinical trial transparency

The European Parliament has approved new measures to force researchers to make their clinical trial results available, with fines available to deal with non-compliance.

MEPs voted by an overwhelming majority to pass the new EU Clinical Trials Regulation, which will require pharma and academic researchers to post all their European Clinical Trial results – including for negative studies.

The law, which is expected to take effect in 2016, will also facilitate cross-border cooperation on trials – potentially improving efforts to study rare diseases by opening up a greater pool of patients and reducing costs.

The legislation was steered through the Parliament by the UK's Glenis Willmott, who said she was delighted by the backing given by her fellow MEPs.

"It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe.

"The new law will also offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct. There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases.”

The changes will simplify reporting procedures and empower the European Commission to carry out checks, with fixed deadlines for member states to respond to product application dossiers from clinical trial sponsors.

In a bid to improve trial transparency, detailed summaries - including full clinical study reports – will have to be published in a publicly-accessible EU database, once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn.

European pharma body EFPIA said the adoption of the new Clinical Trials Regulation would “help foster a more harmonised approach to clinical trials in the EU, with a single submission and overall streamlined assessment process”.

It added: “EFPIA also welcomes the legislation's approach to transparency, which respects the need to protect personal patient data and commercially confidential information.”

But the body added it would be critical that the Commission and EMA interpret the law in such as way as to “respect patient privacy, the integrity of regulatory decision-making and incentives for companies to make long-term investments in biomedical research”.

1 J: B9 M, S8 o- R+ z3 z+ G( I

美丽   美丽  哈哈哈 哈哈哈

中国的临床实验，还很不规范，医生的合规性意识很低，习惯于高高在上