Latest From Brenda Sandburg
As sponsors and US FDA continue to face fallout, newly launched digital archive of industry documents from opioid litigation and settlements will be free public resource for those investigating activities that led to the opioid epidemic. It is modeled on the archive of tobacco industry documents, which has been the basis of about 1,000 scientific publications.
COVID-19 Therapeutic Trials: Investigators Should Join Forces Rather Than Conduct Single Site Studies
‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.
US FDA Acting Commissioner Woodcock says there is ‘a long list’ of lessons learned in the OWS therapeutics group, noting trial bureaucracy and the lack of resources and support for community centers.
CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.
NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.
FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.