While medicines are traditionally developed in relatively simple randomized trials in which the effect of a new treatment is tested against a standard treatment in a large group of patients, the Danish Medicines Agency explained that this approach cannot be applied to personalized medicines as these are usually developed with fewer patients who are selected, for example, based on their specific DNA profile.

Sponsors have, therefore, been experimenting with complex trials, which offer the opportunity to develop medicines that can be tailored to an individual patient with a specific genotype. As the increased complexity of such trials could expose subjects to greater risks or impair the quality of data generated, making it difficult to understand the trial results, there was a need to develop common EU guidelines to harmonize the conduct of complex trials.

EU Addresses Complex Clinical Trial Designs In New Guideline

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