EMEA: Guideline on Missing Data in Confirmatory Clinical Trials

The Committee for Medicinal Products for Human Use (CHMP) has adopted the Guideline on Missing Data in Confirmatory Clinical Trials for release for consultation. End of consultation (deadline for comments) is 31 October 2009. The guideline will replace the 'Points to Consider on Missing Data in Clinical Trials' CPMP/EWP/1776/99.

Missing data are a potential source of bias when analysing clinical trials. Interpretation of the results of a trial is always problematic when the number of missing values is substantial. This problem is only partially covered in ICH E9 (Statistical Principles of Clinical Trials). The new guideline CPMP/EWP/1776/99 will provide advice on how the presence of missing data in a confirmatory clinical trial should be addressed in a regulatory submission. The pattern of missing data (including reasons for and timing of the missing data) observed in previous related clinical trials should be taken into account when planning a confirmatory clinical trial. This information should be used to minimise the amount of missing data present in a confirmatory clinical trial and assist in the choice of the method used to analyse the primary endpoint.

The Guideline should be read in conjunction with Annex I to Directive 2001/83/EC, as amended, and all other relevant EU and ICH guidelines like for example CPMP/ICH/363/96, ICH Topic E9 Step 4 Note for Guidance on Statistical Principles for Clinical Trials.

This document is not an extensive review of all the available methods. Instead general recommendations on acceptable frameworks for handling missing data in a regulatory setting are outlined.

Compiled by
Wolfgang Schmitt
On the behalf of the European Compliance Academy (ECA)

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