10/26/2022 0 Comments Lord of rigel xantus![]() The NIH is the largest funder of academic biomedical research in the U.S., and it also runs the clinical trials database. LORD OF RIGEL XANTUS TRIALClinical trial reporting violations, 2008-2017 and a founder of projects to press for openness in clinical research. Ben Goldacre, a fellow at the University of Oxford in the U.K. That investigation and assessments by other groups “shows the power of public accountability … for fixing what is probably the single most important flaw in the fabric of evidence-based medicine,” said Dr. STAT was the first to examine the reporting track records of individual institutions, and the improvement by the worst offenders suggests that naming names drove better reporting, experts said. Mark Cullen, senior associate dean for research at Stanford Medical School. “We put everyone on notice that we consider this an extremely high priority,” even for busy and sometimes-recalcitrant faculty, said Dr. Such formerly routine violators improved, on average, from reporting the results of just 35 percent of studies to 76 percent. Many of the biggest gains were at research institutions singled out for woeful reporting in the earlier STAT investigation, including Memorial Sloan Kettering Cancer Center, the University of Pittsburgh, and Stanford University. That compares with 58 percent just two years earlier.įailure to report: A STAT investigation of clinical trials reporting ![]() Overall, trial sponsors had disclosed 72 percent of required results to the federal database as of September 2017. The reporting of clinical trial results to a public database - mandated by a 10-year-old federal law - has improved sharply in the last two years, with universities and other nonprofit research centers leading the way, according to a new STAT analysis of government data. (The details of that site’s methodology are here.) You can also read a detailed description of the methodology STAT used to analyze the database here. 18, 2017, you can check this TrialsTracker website to determine whether the results are overdue. Thankfully, this transparency loophole has been partly fixed under the new rules, and for trials completed since Jan. Based on this new information, we have created a separate list of trials that sponsors say were unapproved and thus exempt, and have linked to any documentation provided by the sponsors. Unfortunately, this means that for many older trials, there is no practical way for STAT or anyone else to verify which ones are exempt, but this story and the accompanying data visualization remain the most accurate assessment possible. For such studies, requesting a formal “certification for delay” was optional, the official said. ![]() 18, 2017 - when new regulations went into effect - could delay reporting the results without seeking a formal exemption, if the drug being tested had not been approved by the Food and Drug Administration. But an agency official subsequently told us that organizations running studies completed before Jan. Before publication, NIH had described this list as a complete accounting of exempt trials. Exclusive analysis of biotech, pharma, and the life sciences Learn MoreĮditor’s note: After this story was published, we learned that we mistakenly counted some studies as violators of the reporting law because they were not included on a list of exempt studies provided to STAT by the National Institutes of Health. ![]()
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