Quality of Life Assessments in the Development and Clinical Trials of New Antipsychotics: Pharmaceutical Industry Perspective
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Quality of life (QoL) assessments illustrate the patients’ subjective views and needs and can play a key role in drug development of treatments for schizophrenia. So far, QoL data from trials with antipsychotics are mainly used for commercial and promotional purposes or for negotiations on pricing and reimbursement. In the future, a greater focus on QoL could change the development process and guide research for the next generation of treatments, since these will have to significantly improve outcomes and not simply reduce symptoms or re-hospitalization rates. The chapter identifies important aspects of methodology with regard to the selection and use of QoL assessments in drug development. So far, there are no universally accepted operational definition of QoL and no “gold standard” instrument. Based on a variety of theoretical constructs that cover general and disease-specific aspects of health-related quality of life (HRQL), there is a suitable choice of assessment tools with adequate psychometric properties. Cautious selection according to the specific aims of a trial and a sensible integration into clinical programs can help uncover crucial properties of treatments that are vital for reaching ambitious goals like recovery from the illness. However, besides treatment, QoL assessments are also influenced by illness-related and other factors, which need to be considered judiciously to draw valid conclusions from trials. It is now evident that a vast majority of patients with schizophrenia can provide relevant information on HRQL. Regulatory authorities have declared their willingness to review claims based on QoL data and are providing guidance documents to sponsors for this purpose, which can also apply to schizophrenia.
KeywordsNegative Symptom European Medicine Agency HRQL Change Neuroleptic Dysphoria European Medicine Agency Reflection Paper
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