NIH wants to expand the scale of clinical trial database

Source: bio360 2014-12-5 a proposal will require sponsors of experimental studies to publicly report their findings, even if they have not produced an approved product According to a draft recently submitted by the United States, the number of clinical data that pharmaceutical companies must share with the public will soon increase Under the proposal, test sponsors need to report the results of drug trials and unapproved medical devices, not just those products that have entered the market The plan, published by the U.S Department of public health services (HHS), aims to ensure that summaries of drug trials that have been abandoned due to trial failures or other reasons can still enter the public database: clinicaltrials.gov Sharing the results of these experiments will not only be useful for researchers, but also for those who volunteer to participate in the experiment to "fulfill their social and ethical responsibilities" "What happened?" Francis Collins, President of the National Institutes of health, said at a press conference? We owe the patients and the participants an explanation " Sharing data can also help researchers avoid repeating failed experiments, government officials said At the request of Congress, the NIH public database, clinical trials.gov, was launched in 2000 and currently includes registration data for more than 178000 experiments; sponsors of all experiments controlled by the food and Drug Administration (FDA) are required to register According to the law of 2007, within one year after the completion of the experiment, pharmaceutical companies must also submit their research summary, including the number of participants, age, gender, results and adverse reactions More than 15000 experiments have submitted these summaries However, these summary requirements only apply to FDA approved drugs and medical devices According to HHS's new regulations, companies are required to submit research results that have not been approved Deborah zarin, director of clinicaltrials.gov, said this would add another 100 to 150 studies to the database's current weekly intake of 100 NIH also plans to require the results of all clinical trials it funds to be submitted to clinicaltrials.gov At present, only FDA regulated researchers who conduct product experiments must register the experiments and report the results.