Most Decisions to Approve or Reject New Drugs Based on Poor Clinical Data, Study Suggests

Researchers at the London School of Economics (LSE) have found that most decisions to approve or reject new drugs, medical procedures, and devices are not based on solid clinical data, with no improvement in the past 20 years. The study, published on BMJ Open, examined 400 appraisals made by the National Institute of Health and Care Excellence (NICE) and the data used to inform them, finding that around two-thirds of decisions were not backed by good quality evidence. Just 1 percent of cases were classed as having a “good” quality of evidence, with around a third considered to have an “acceptable” basis for approval or rejection. The study found the data was “consistently poor” with no improvement in its quality between 2000 and 2019....