EMA Proposes Changes to Existing Clinical Trial Guideline on Multiplicity Issues

The European Medicines Agency (EMA) is calling for a new guideline on multiplicity issues in clinical trials in a new concept paper released on 30 May.

EMA first released a paper on multiplicity issues, which are the array of different variables and factors acting upon and within a study, in 2002. "Since then," writes EMA," it has been proven to be useful for both industry and regulators when planning and assessing confirmatory clinical trials."

Further advances in methods and analysis have driven clinical trial complexity to new limits, which is raising new questions, problems and issues, explains EMA. The agency is proposing to look at "additions and modifications" that may be necessary for the existing guidance while avoiding giving advice on "technical questions related to a [specific] new methodology."

EMA said it hopes to look at, among other problems, the construction of simultaneous confidence intervals and the usefulness of newly developed methods such as gatekeeping and fallback procedures.

Read more:

EMA - Concept paper on the need for a guideline on multiplicity issues in clinical trials

EMA - Points to Consider on Multiplicity Issues in Clinical Trials (2002)