Negative results are publicly available

In the USA, pharmaceutical companies are required to publish all the results of clinical trials

Julia Korowski, XX2

The US Department of Health has tightened the requirements for registration of clinical trials. The regulation adopted by the agency obliges pharmaceutical companies to publish information about the results of clinical trials, even in cases where drugs have proved ineffective (HHS takes steps to provide more information about clinical trials to the public).

"Through clinical research, we learn what works and what doesn't," says Francis S. Collins, director of the U.S. National Institutes of Health (the government agency responsible for health and biomedicine research). "However, it was not easy to find out about the results of these tests, or at least to find out what kind of research is being conducted at the moment," he continues. "We know that the results of almost a third of the studies funded by our department are not published, most often this happens when they turn out to be negative. But we also want to know about these results," Collins says.

On September 16, the US National Institutes of Health (NIH) announced the approval of two legislative acts concerning the registration of clinical trials in a single database ClinicalTrials.gov . The first of them – the final regulations adopted by the Ministry of Health – obliges pharmaceutical companies to publish negative results of clinical trials and report side effects if they occur more often than in 5% of cases. Researchers should indicate in advance the methods of analyzing the results and provide information about the study participants, in particular, data on their race and ethnicity. These rules relate to the testing of medicines, biological preparations and medical equipment, which are regulated by the Food and Drug Administration (FDA). They do not apply to studies of the clinical and economic feasibility of equipment and clinical studies of the first phase, during which the safety of drugs is tested on healthy volunteers.

The second important piece of legislation is the new NIH regulations. They regulate the registration of clinical trials funded by this agency. The rules extend the effect of the regulations: they oblige you to enter into the database ClinicalTrials.gov studies of behavioral interventions (such as diet and meditation) and other non-FDA regulated products, as well as phase I clinical trials. According to Francis S. Collins, violation of these requirements may lead to the fact that organizations will no longer receive money from the National Institutes of Health for scientific research.

The documents require registration of clinical trials within 21 days after the start of the trials and publication of the results one year after their completion. They come into force on January 18, 2017.

The U.S. government has long attempted to make clinical trials more transparent. In 2000 , the website was launched ClinicalTrials.gov , in 2007, the FDA required sponsors to publish the results a year after their completion. However, until now the laws were not clear enough, and therefore their execution was easily avoided. According to an article in The New England Journal of Medicine from last year, the results of only 17% of studies funded by pharmaceutical companies, 8.1% by NIH and 5.7% by other institutions were registered in due time.

Portal "Eternal youth" http://vechnayamolodost.ru  19.09.2016