EMA must improve the quality of its clinical trial reports

doi:10.1136/bmj.d2291

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Corrado Barbui, associate professor of psychiatry,
Cinzia Baschirotto, researcher,
Andrea Cipriani, lecturer in psychiatry

¹WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy

Correspondence to: C Barbui, Section of Psychiatry and Clinical Psychology, Policlinico G B Rossi, Piazzale L A Scuro 10, 37134 Verona, Italy corrado.barbui{at}univr.it

Accepted 15 March 2011

Corrado Barbui, Cinzia Baschirotto, and Andrea Cipriani find that the results of phase III studies are poorly and inconsistently documented in the EMA’s drug assessment reports. Better reporting would make them more useful for doctors, researchers, and consumers

In Europe, new drugs are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency. However, the transparency of the approval process has been criticised.1 2 Calls have been made for the European Public Assessment Report (EPAR), a summary of the grounds for granting marketing authorisation (box 1), to include additional information on critical points examined and discussed during assessment such as whether a drug is approved by majority vote, the reasons for the minority’s opposition, and decisions of other licensing bodies, in a timely and user friendly format.1 2

Box 1: Assessment of new drugs in Europe

European Medicines Agency (www.emea.europa.eu)

The European Medicines Agency (EMA) is an agency of the European Union responsible for the scientific evaluation of medicines developed by drug companies for use in EU countries. The EMA’s decisions on new or old medicines relating to changes in therapeutic indications, approval, suspension, or withdrawal of a product have to be accepted by all EU members.3

European public assessment report

Once the EMA has given marketing authorisation for a drug, it publishes a scientific assessment called the European Public Assessment Report (EPAR). The EPAR, written in agreement with the industry,4 summarises the documentation produced by the manufacturer and describes procedures that led to the EMA approval. EPARs are published on the EMA’s website after commercially confidential information has been deleted (www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp).

Surprisingly, no criticism has been raised about the quality of the information that is currently available, especially the quality of reporting of phase III studies. This is an important aspect considering that new drugs …