EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations

CONCLUSIONS: The EMA and FDA clinical research guidelines for psychiatric pivotal trials recommend designs that tend to have limited generalisability. Independent and non-conflicted stakeholders are underrepresented in the guideline development. It seems warranted with more active involvement of scientists and independent organisations without conflicts of interest in the guideline development process.PMID:33926608 | DOI:10.1017/S2045796021000147

Source: Epidemiology and Psychiatric Sciences - April 30, 2021 Category: Psychiatry Authors: Kim Boesen Peter C G øtzsche John P A Ioannidis Source Type: research