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Patient-reported outcomes - Qualitative research in the pharmaceutical industry

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Séminaires «Psychothérapies & Sciences»
par Mme Laure DELBECQUE, Docteur en Sciences Psychologiques et Project manager in Electronic patient-reported outcomes (ePRO), Business & Decision - Brussels.
Le 12 février 2013

The presentation will give an introduction to patient-reported outcomes (PRO) and present methods to develop PRO measure through rigorous qualitative research in order to enhance the integrity of the PRO data gathered in clinical trials.

Patient-reported outcomes (PRO) are data (e.g., symptoms, impact of the disease), that come directly from the patient, without the interpretation of a health professional. These data are collected through a questionnaire or diary and are mainly used to assess treatment benefit and satisfaction in clinical trials, effectiveness studies, and public health research. They complement the use of clinician evaluations, objective statistics (e.g., survival rates), and other traditional indicators of clinical efficacy and safety and therefore optimize labeling claims, support regulatory and reimbursement submissions, and enable value based differentiation. However, obtaining valid, protocol compliant and exploitable PRO data remains a challenge for the pharmaceutical industries. The presentation will give an introduction to PRO and present methods to develop PRO measure through rigorous qualitative research in order to enhance the integrity of the PRO data gathered in clinical trials.