A joint press release issued by ISDB, MiEF and Nordic Cochrane Centre regarding the recently published report on EMA's controversial "adaptive pathways" pilot project. The report includes no new factual data, with no information shared about the drug's indications, type of clinical trial data to be submitted or which patient representatives were consulted. In the absence of any real information the pilot is clearly a failure and should be retracted. If “commercial sensitivities” prevent detailed reporting to the public, it is doubly a failure. No fundamental shift to regulation should be based on such secrecy.
Click below to read this press release.