Reporting of studies on new medicines in major medical journals: a case study in breast cancer

Abstract

A comparison of the results of pivotal trials on three new medicines for advanced breast cancer published in medical journals with those presented in the US Food and Drug Administration (FDA) reviews showed that analyses reported in journals were of lower quality and were given a favorable interpretation by minimizing toxicity and ignoring methodological shortcomings. Several proposals to strengthen the quality of reporting of clinical trials in medical journals and to support reliable assessment of the therapeutic value of new medicines are discussed.