Expert consensus recommendations on the use of randomized clinical trials for drug approval in psychiatry- comparing trial designs

Bayesian analysis of real‐world data as evidence for drug approval: Remembering Sir Michael Rawlins

“…The two pillars of modern medical research are where in most randomized controlled trials (RCTs), the active treatment is compared with placebo. A recent expert consensus survey endorsed the statement that ‘Results from placebo‐controlled trials are more reliable than results from any other study design’, 1 reflecting that placebo controlled RCTs are considered to be the gold standard. However, in his 2008 Harvein Oration, the prestigious annual lecture of the Royal College of Physicians of London, Sir Michael Rawlins, the ex‐head of the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA), pointed out RCTs are not the apex of evidence, but rather a piece of a larger evidence puzzle.…”

The difference between ‘placebo group’ and ‘placebo control’: a case study in psychedelic microdosing

“…In medical research the gold standard experimental design is the blinded randomized controlled trial 1 , where ‘blinding’ refers to the concealment of the intervention 2 . The purpose of blinding is to equally distribute expectancy effects between treatment arms 3 , thus, to eliminate biases associated with expectancy.…”

Tough times never last too long: the future of psychopharmacology

“…Nevertheless, some hurdles are still there. An obvious one is the increasing difficulties in signal detection with placebo‐controlled trials 7 and the limited alternatives to placebo‐controlled designs 8 , as well as problems related to the representativeness of the patients enrolled in those trials and the generalizability of the findings 9 . Regulatory agencies are not consistent across the world in their requirements for marketing approval of medications, and this carries increased costs and inequalities.…”