"没事走两步" 美国拟要求将药物研发临床数据信息上网公布

每个生物医药公司都十分重视本公司的临床研究数据保密，除了提交FDA审核以及必要的信息披露。很少见到生物医药公司主动将研究的细节公之于众。此外，医药公司一般都会倾向于公布获得成功的研究数据，颇有报喜不报忧的嫌疑。最近美国卫生部联手美国国家健康研究中心正在考虑推行一项措施要求医药研发企业让必要的临床研发数据公布在指定网站上。不过NIH指出这一措施不包括临床一期研究和可行性研究。研发机构不需要对现有设计方法进行刻意修改，只需要按照FDA的有关要求进行设计即可。此举的另外一个目的是增加医药研发的透明度，通过这种方法避免医药研发中不必要的重复从而降低医药研发的成本。参与这一工作的Francis Collins认为，最大限度的公开这些信息在医学研究的过程中具有重要意义，此举能够最大限度的利用这些临床信息的价值，为不同的研究人员提供多方位的参考。目前这一政策尚在讨论之中，需要在征求相关企业和分析人士的意见之后才会作出最后决定。

其实随着医药研发全球化进程的不断深入，许多生物医药巨头都已经看到了研究数据公开的必然性并且已经开始作出改变。例如赛诺菲、拜耳等公司会在ClinicalStudyDataRequest.com公布获得批准的药物相关临床研究数据。而葛兰素史克公司和强生公司也已经决定公布一系列的匿名研究数据。可以说，今后生物医药研究的透明度将更上一个新台阶。

详细英文报道：

Federal regulators are proposing a rule that would require makersof drugs and medical devices to publicize the results of thousands of clinicaltrials, regardless of whether they succeed, part of a global move towardtransparency in R&D.

The proposal, developed by the Department of Health and HumanServices and the National Institutes of Health (NIH), would require the makersof unapproved drugs and devices to post summaries of study results onClinicalTrials.gov, the government's public portal, within a year of trialconclusion. As it stands, sponsors are required to disclose results only onstudies of approved products, which account for about 15,000 of the roughly178,000 trials posted on the site, according to NIH.

The new rules, if adopted, would generally exclude Phase I andfeasibility trials, NIH said, and they wouldn't alter the trial-designrequirements needed to win FDA approval. Instead, they would greatly expand thepublic pool of clinical results, preventing unnecessary duplication, weedingout unsafe or ineffective products, and informing future research, according toNIH.

"Medical advances would not be possible withoutparticipants in clinical trials," Director Francis Collins said in astatement. "We owe it to every participant and the public at large tosupport the maximal use of this knowledge for the greatest benefit to humanhealth. This important commitment from researchers to research participantsmust always be upheld."

The proposed changes would also streamline the rules for justwho is required to submit trial information; expand the amount of informationthat must be disclosed shortly after study startup; and force sponsors toupdate their ClinicalTrials.gov entries more regularly.

HHS and NIH are soliciting feedback on the proposal fromindustry and academia through Regulations.gov, opening up a 90-day window fordiscussion before making a final decision on the new rules.

Meanwhile, some of the world's largest drug developers havecapitulated to the prodding of global regulators, making varying amounts ofdata available through ClinicalStudyDataRequest.com. Some, like Sanofi ($SNY)and Bayer, are disclosing only the results on newly approved products, whileothers, including GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ), haveagreed to hand over huge swaths of anonymized data in the interest of globalR&D.

来自：生物谷