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patient subgroups. For example, in oncology, markers such as KRAS, HER-2/neu and BRCA 1,2 are used for prognosis and to direct treatment. To reflect this evolution, comparative effectiveness research programme designs and analytical methods must be able to detect important treatment effects and outcomes for specific patient subgroups. The emergence of patient-centered care adds further complexity to HTA data requirements. The systematic collection of patient-reported outcomes (PROs) and their application to medicine is far from standard in clinical practice, although many clinical trial programmes now include the collection of PROs. For products in development, data generation plans must reflect ongoing changes and evolving complexities. We will review the growing range of methods employed in clinical effectiveness research, and show how personalised medicine and patient outcome programmes can strengthen HTA data packages.