Deficiencies in clinical reports for registration of drugs

Abstract

A considerable number of the clinical reports which are presented to the Dutch Board for the Evaluation of Drugs, have deficiencies and/or shortcomings. A number of these, including loose description of the target population and sampling method, methodological flaws, incorrect treatment of withdrawals, confounding of patients and observations per patient, incomplete or incorrect description of the data and incorrect or inappropriate use of statistical tests, are discussed.