Sanofi PRO 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.

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Presentation of new methods to get patient feedback in clinical trials at ISOQOL, October 2019

Sanofi COG team attended the 26th annual ISOQOL (International Society for Quality of Life Research) conference (20-23 Oct 2019 at San Diego, CA) and participated to the “Tell me more: Qualitative and quantitative methods for eliciting supplementary data regarding patient experiences during clinical trials and observational studies” symposium. The symposium included four presentations each providing a unique perspective on the use of patient-centred research methods for the evaluation of patient experiences during clinical trials. Adam Gater from Adelphi Values emphasized on the value of qualitative research for gathering patient insights during drug development and evaluation. Linda Nelson from GSK explained who, what, when, why and how to use patient qualitative interviews within clinical research studies. Aude Roborel de Climens shared the new Patient’s Qualitative Assessment of Treatment (PQAT) questionnaire Sanofi has developed to collect individualized patient experience of treatment and first tested in a phase 2 diabetes study. The PQAT combines 3 qualitative open-ended questions on benefits and disadvantages of treatment experienced during clinical trials; and reasons for willingness to continue treatment or not, and an overall quantitative evaluation of the balance patients make between the treatment benefits and disadvantages they experienced. The richness and value of such mixed-method approach to various stakeholders was appreciated by the audience to identify concepts that may not be traditionally captured in standard PRO questionnaires or typically considered in benefit-risk frameworks. Then, Stéphanie Manson from Novartis presented the development, testing and implementation of the Trial Feedback Questionnaire, a PRO questionnaire designed to understand the experience of patients participating in clinical trials. Finally, all discussed the value and challenges of such new methods to elicit patient feedback during clinical studies, with an audience of more than 80 people from patient-reported outcome (PRO) / clinical outcome assessment (COA) academics, pharmaceutical or service companies and FDA.

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06-Nov-2019 10:02

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-making

The 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:

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05-Sep-2019 14:04


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!

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23-Jul-2019 08:36