Most novel medicines that are introduced in day to day clinical practice are first approved by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We are studying these approval processes.
DATA SHARING AND RE-ANALYSIS FOR PIVOTAL RANDOMISED CONTROLLED TRIALS ASSESSED BY THE EUROPEAN MEDICINES AGENCY -A SURVEY OF EUROPEAN PUBLIC ASSESSMENT REPORTS
This registered report introduces a cross-sectional study aiming to assess inferential reproducibility (i.e. Individual Patient Data is available and qualitatively similar conclusions can be drawn from a reanalysis of the original trials) for main RCTs assessed by the European Medicine Agency (EMA).
TIVOZANIB IN RENAL CELL CARCINOMA: A SYSTEMATIC REVIEW OF THE EVIDENCE AND ITS DISSEMINATION IN THE SCIENTIFIC LITERATURE
To critically review the evidence supporting the approval conflicting decisions by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA); and to analyse the dissemination of this evidence in the literature by way of a citation analysis.
AN OPEN SCIENCE PATHWAY FOR DRUG MARKETING AUTHORISATION-DRUG REGISTERED APPROVAL
In this essay, we propose a pathway involving open science and registered criteria for evaluation and approval of new drugs.
EFFICACY AND SAFETY OF ESKETAMINE FOR "TREATMENT RESISTANT DEPRESSION": REGISTERED REPORT FOR A SYSTEMATIC REVIEW WITH AN INDIVIDUAL PATIENT DATA META-ANALYSIS OF RANDOMISED DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS
In 2019, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved a nasal spray formulation of esketamine for “treatment resistant depression” (TRD). However, the evidence base for its use proved to be controversial. This registered report aims to independently reappraise the efficacy of esketamine in TRD.
Protocol / Work in progress, in principle acceptance at BMC Medicine