Objective: Including qualitative research in clinical trial design is an innovative approach to understanding patients' perspective and incorporate the patient's voice in all stages of drug development and evaluation. This review aims to explore current practices, lessons learned from the literature, as well as how qualitative interviews are considered by health authorities for marketing authorization and reimbursement.
Methods: A targeted literature review of Medline and Embase databases was conducted in February 2022 to identify publications on qualitative methods embedded in clinical trial of pharmaceutical products.
Background: In 2022, it was estimated that more than 80,000 new cases of bladder cancer (BC) were diagnosed in the United States, 12% of which were locally advanced or metastatic BC (advanced BC). These forms of cancer are aggressive and have a poor prognosis, with a 5-year survival rate of 7.7% for metastatic BC.
View Article and Find Full Text PDFExpert Rev Pharmacoecon Outcomes Res
March 2023
Introduction: Depending on countries and health systems, medico-economic assessment guidelines recommend to adopt one or several perspectives. We conducted a systematic literature review in order to assess the fit between the country guidelines and the perspectives announced in the published studies.
Areas Covered: Searches were carried out within the Medline electronic database for records published between 1 January 2000 and 31 August 2020.
Background: Locally advanced or metastatic bladder cancer (BC), which is generally termed advanced BC (aBC), has a very poor prognosis, and in addition to its physical symptoms, it is associated with emotional and social challenges. However, few studies have assessed the unmet needs and burden of aBC from patient and caregiver perspectives. Infodemiology, that is, epidemiology based on internet health-related content, can help obtain more insights on patients' and caregivers' experiences with aBC.
View Article and Find Full Text PDFObjective/background: This study evaluated psychometric properties of the Pediatric Narcolepsy Screening Questionnaire (PNSQ), developed in response to the difficulty of identifying pediatric narcolepsy.
Patients/methods: The initial PNSQ was updated following debriefing interviews with parents of children with suspected/diagnosed narcolepsy. Subsequently, newly recruited caregivers were categorized into groups: clinician-confirmed narcolepsy, other sleep problems (OSP), and no sleep problems (controls).