Biostatistical Methodology in Clinical Trials

Status Last revised May 1993 Previous titles/other references Biostatistical methodology in clinical trials in applications for Marketing Authorisations for Medicinal Products/ III/3630/92, Additional Notes This note for guidance concerns the application of Part 4, sections C and F of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It is intended to give support to applicants when designing, conducting, documenting, evaluating and reporting clinical trials of new medicinal products in the context of their overall clinical development. It is written primarily to harmonise the biostatistical methodology applied to clinical trials within member states, during both clinical development and subsequent review.