FDA report examines 22 drugs passed phase 2 flopped phase 3

To understand the essence of evidence got from a number of phase 2 trials and also the donations of phase 3 trials of medication, vaccines and medical devices, FDA studied 2-2 recent cases by which promising phase 2 clinical trial results weren’t confirmed in period 3 clinical testing. Period 3 studies didn’t confirm phase-2 findings of efficacy at 14 cases, safety in 1 instance, and both security and efficacy in seven cases. These unexpected results may occur even once the phase two analysis was relatively big as well as though the phase 2 trials evaluated clinical outcomes.

These case studies reveal that high phase 3 randomized controlled trials may create significant evidence across all kinds of merchandise, patients, as well as even diseases. Both security and efficiency failures happened even if the phase 2 studies had been relatively high, and also though the merchandise was approved for one more condition. Sometimes, the phase 3 analysis demonstrated that shortterm consequences found at the phase two study weren’t related to a longterm benefit or that the merchandise needed toxicity which wasn’t found at the phase two study.


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