Many academic researchers who fail to report clinical trial results in accordance with federal law have received funding from the pharmaceutical companies involved in the studies, a STAT investigation found. An earlier STAT report indicated that academic medical centers, teaching hospitals and nonprofit groups, including some of the top recipients of NIH research funding, routinely fail to report trial results to ClinicalTrials.gov.
While makers of wearable health devices currently on the market sought to avoid the FDA approval process, a new crop of wearable-device makers are developing products to track serious conditions like epilepsy and diabetes and will have to clear the agency's regulatory hurdles if they want to get a piece of what industry analysts estimate could be a $41 billion market by 2020.
Push on to make transparent medical records the national standard of care | Kaiser Health News/NPR
What happens when patients have easy access to their doctor's appointment notes? The OpenNotes research project set out five years ago to find out, with 20,000 participating patients and 100 physicians at Boston's Beth Israel Deaconess Hospital, Harborview Medical Center in Seattle, and Geisinger Health System in Pennsylvania and New Jersey. More than 90% of patients liked the transparency and over two-thirds of doctors agreed. This week, OpenNotes got $10 million in new grants to expand the project to possibly 50 million patients nationwide.
Ted Cruz's best idea for overhauling the FDA | Atlantic
Texas Sen. Ted Cruz would like physicians and patients in the U.S. to be able to access drugs and medical devices which have already been approved in other trusted nations without having to wait for the FDA to approve them first, so Cruz and Utah Sen. Mike Lee have introduced a bill (PDF) to overhaul the approval process at the agency to include reciprocal marketing.