The United States intends to require the publication of clinical data information on drug development on the Internet

Source: Biovalley 2014-11-20 has always attached great importance to the confidentiality of the company's clinical research data, in addition to submitting to FDA for review and necessary information disclosure It is rare for biopharmaceutical companies to take the initiative to disclose the details of their research In addition, pharmaceutical companies generally tend to publish successful research data, which is suspected of reporting good news but not bad news Recently, the U.S Department of health, together with the National Center for health research, is considering a measure to require pharmaceutical research and development enterprises to publish necessary clinical research and development data on designated websites However, NIH pointed out that this measure does not include clinical phase I study and feasibility study The R & D organization does not need to modify the existing design method deliberately, but only needs to design according to the relevant requirements of FDA The other purpose of the move is to increase the transparency of pharmaceutical research and development, and reduce the cost of pharmaceutical research and development by avoiding unnecessary duplication in pharmaceutical research and development Francis Collins, who participated in the work, believes that it is of great significance to make the most of these information in the process of medical research, which can make the most of the value of these clinical information and provide multiple references for different researchers At present, this policy is still under discussion, and a final decision will be made only after the opinions of relevant enterprises and analysts are solicited In fact, with the deepening of the globalization of pharmaceutical research and development, many biomedical giants have seen the inevitability of research data disclosure and have begun to make changes For example, Sanofi, Bayer and other companies will publish approved drug-related clinical research data at clinicalstudydatarequest.com GlaxoSmithKline and Johnson & Johnson have also decided to release a series of anonymous research data It can be said that the transparency of biomedical research will take a new step in the future Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thoughts of clinical trials, regulations of which they succeeded, part of a global move forward transparency in R & D, developed by the Department of Health and Human Services and the National Institutes of Health (NIH), would require the makers of unapproved drugs and devices to post summaries of study results on ClinicalTrials.gov, the government's public portal, within a year of trial conclusion As it stands, sponsors are required to disclose results only on studies of approved products, which account for about 15,000 of the roughly 178,000 trials posted on the site, according to NIH The new rules, if adopted, would generally exclude Phase I and feasibility trials, NIH said, and they wouldn't alter the trial-design requirements needed to win FDA approval Instead, they would greatly expand the public pool of clinical results, preventing unnecessary duplication, weeding out unsafe or ineffective products, and informing future research, according to NIH "Medical advances would not be possible without participants in clinical trials, " Director Francis Collins said in a statement "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health This important commitment from researchers to research participants must always be upheld." The proposed changes would also streamline the rules for just who is required to submit trial information; expand the amount of information that must be disclosed shortly after study startup; and force sponsors to update their ClinicalTrials.gov entries more regularly HHS and NIH are soliciting feedback on the proposal from industry and academia through Regulations.gov, opening up a 90-day window for discussion before making a final decision on the new rules Meanwhile, some of the world's largest drug developers have capitulated to the prodding of global regulators, making varying amounts of data available through ClinicalStudyDataRequest.com Some, like Sanofi ($SNY) and Bayer, are disclosing only the results on newly approved products, while others, including GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ), have agreed to hand over huge swaths of anonymized data in the interest of global R&D