Sanofi PRO Questionnaires

Capturing the patient’s perspective through Patient-Reported Outcome questionnaires

Health is more than the absence of disease. It has physical, social and psychological components that can only be understood by asking and listening to those who have ill health and/or require medication. For more than 20 years, Sanofi has explored how diseases and medication impact patients’ daily life through the use of Patient-Reported Outcome (PRO) questionnaires. These questionnaires capture the perspective of those who are living with the disease on many topics of central importance for them, such as disease signs and symptoms, physical functioning, quality of life, satisfaction, or medication side-effects.

We have implemented many existing PRO questionnaires in our clinical programs over the years. When existing questionnaires were inadequate or concepts of importance to patients had not been previously evaluated, we developed new PRO questionnaires. These questionnaires were developed alongside patients in a scientifically rigorous manner to ensure robust and holistic evaluation of things that matter to them. This website presents the PRO questionnaires developed by Sanofi and those currently in development, to all who may be interested: pharmaceutical companies, academics, clinicians, and patients.

Our PRO Questionnaires

CARDIOVASCULAR DISEASES

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VIRUS DISEASES
VIRUS DISEASES
NUTRITIONAL & METABOLIC DISEASES

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areas in which Sanofi has developed
PRO questionnaires

Latest News

Sanofi at the 4th Annual FDA-ASCO Workshop on PROs in Oncology

On July 12, 2019, one member of Sanofi’s Department of Clinical Outcomes Generation (COG) Team (virtually) attended the 4th Annual FDA-ASCO Workshop on PROs in Oncology which was held at the FDA in Silver Spring, MD.The focus on the workshop was on physical function as an outcome measure in oncology-given that physical function (PF) is a key functional domain of health-related quality of life in oncology and is considered a well-defined clinical outcome important across cancer types. In addition, PF can be measured by both existing PRO tools as well as emerging wearable technologies.Past FDA workshops have identified disease symptoms, symptomatic adverse events and physical function as core outcomes of interest for FDA product review and have reviewed the characteristics necessary for a PRO tool to be considered fit for purpose for regulatory decision making. Workshop sessions focused on electronic PROs (ePRO) assessment, PROs/ePROs in clinical care, registries, pragmatic trials, and in the real-world, standardization of PRO data collection, COA tools, endpoints, analysis, and visualization of physical function in oncology for regulatory decision-makingThe ICHE9 estimand guidelines were proposed as a framework to develop rigorous PRO endpoints, and to review medical products and approve PRO labeling. The use of PROs from RW settings and the use of patient experience data to inform product development and to inform FDA reviews was also discussed.Minutes of the meeting can be found here: https://www.fda.gov/drugs/news-events-human-drugs/fda-asco-public-workshop-2019-clinical-outcome-assessments-cancer-clinical-trials-fourth-annual

05-Sep-2019 14:04 Read more

A NEW PRO QUESTIONNAIRE FOR THE EVALUATION OF INDIVIDUALIZED BENEFIT-HARM OF DRUGS RECEIVED DURING CLINICAL STUDIES: THE PATIENT’S QUALITATIVE ASSESSMENT OF TREATMENT (PQAT)

Sanofi is proud to announce the availability of the Patient’s Qualitative Assessment of Treatment (PQAT) patient-reported outcome (PRO) questionnaire. The PQAT is a novel methodology that utilizes a mixed-methods approach, combining open-ended free-text questions (qualitative) and quantitative questions with fixed-choice response options. It asks patients about benefits and disadvantages experienced during clinical trials, and how patients balance these benefits and disadvantages when deciding whether or not to continue with treatment.  The PQAT presents an opportunity to explore the value and utility of individualized treatment benefit-harm assessment, which is likely to be of interest to a wide range of stakeholders (including regulators, payers, healthcare professionals, and patients). This questionnaire was cognitively tested with patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), but items are generic enough to be used for any adult patients receiving drugs during clinical trials. Two versions exist, PQATv1 and PQATv2 including 4 and 6  items, respectively. Developed in US English, it was also linguistically validated in 6 languages.Please visit the PQATv2 page for detailed information!

23-Jul-2019 08:36 Read more

NEW QUESTIONNAIRES FOR ACCEPTABILITY OF ORAL MEDICINE FORMULATIONS TO PEDIATRIC PATIENTS: THE PEDIATRIC ORAL MEDICINE ACCEPTABILITY QUESTIONNAIRE (P-OMAQ), PATIENT AND CAREGIVER VERSIONS

In the 2013 Guideline on Pharmaceutical Development of Medicines for Pediatric Use, the EMA highlighted the need to consider medicine acceptability to the patient throughout the pharmaceutical and clinical development of pediatric medicines. Sanofi is proud to announce the availability of the Pediatric Oral Medicine Acceptability Questionnaire (P-OMAQ) in two versions, for patients (P-OMAQ-P) and caregivers (P-OMAQ-C), evaluating pediatric acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers. These patient-reported outcome (PRO) and observer-reported outcome (ObsRO) questionnaires were simultaneously developed with pediatric participants aged 6-17 years and adult caregivers (aged ≥18 years) of pediatric patients aged 6 months to 17 years taking an oral medicine (liquid, powder and pill/tablet formulations). Following an empirical literature review, the conceptual model of pediatric acceptability released was refined by an advisory committee composed of clinicians, researchers, and measurement scientists. Then, combined concept elicitation and cognitive debriefing interviews were conducted using a draft version of the questionnaires with 48 pediatric patients and caregivers stratified by age and oral formulation type. The final P-OMAQ-P and P-OMAQ-C questionnaires include 12 and 19 items, respectively. They  are designed to be self-completed by  young people aged 8–17 years or caregivers of young people aged 6 months–17 years. Both versions have been developed in US English and are available with a 24-hour or a 7-day recall period. These unique content-valid questionnaires reflect the specific attributes of acceptability that are important to pediatric patients and their caregivers, such as happiness in terms of frequency, size, amount, smell, taste, ease to swallow, or willingness to continue.In the context of pediatric clinical drug development, these new questionnaires can bring useful information that may facilitate approval, and marketing initiatives.Please visit the P-OMAQ-P and P-OMAQ-C pages for detailed information!

23-Jul-2019 08:29 Read more