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


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PRO questionnaires

Latest News

Webinar on PACT-Q

In collaboration with Mapi Research Trust, Sanofi is organizing a free educational webinar dedicated to the Perception of Anticoagulant Treatment Questionnaire (PACT-Q) on Thursday, September 27, 2018. The PACT-Q is a valid and reliable instrument that allows the assessment of patients' expectations and satisfaction regarding anticoagulant treatment, as well as their opinion about treatment convenience of use. The objective of this webinar is to present the rationale for developing the PACT-Q, its development and validation, and its conditions of use, as well as its description among other PRO questionnaires within the Sanofi PRO questionnaire website. Please register today to this event and join our expert webinar hosts from Sanofi and Mapi to gain insight into how the health research and pharmaceutical community can use the PACT-Q in clinical research studies.

20-Sep-2018 09:13 Read more

Understanding personalised definitions of health

A recent research paper highlights the heterogeneity in peoples opinions about their health status. A small qualitative study, published in Expert Review of Pharmacoeconomics & Outcomes Research, explored the personalised health perspectives of 14 adults with self-reported diagnoses of cardiovascular disease (CVD). People were asked to segment a 0-100 scale (from the EuroQol 5-dimension questionnaire) into sections to show the boundaries between their own definitions of “poor”, “fair”, “good” and “excellent” health.  There was a notable variability in where people drew the boundaries; the poor-fair boundary ranged between 10 and 50; fair-good between 40 and 75; and good-excellent between 60 and 91. Usually, when looking at PRO data, it is inherently assumed that a self-reported health score has the same meaning for all i.e. a score of 40 for three separate respondents would be indicative of the same level of health status. However, the above study suggests that if three respondents provided a rating of 40 on the scale, one may believe that their health was good, another fair, and the third, poor. Similarly, respondents providing a rating of 60 could consider themselves to be in excellent, good, or just fair overall health. This finding underscores the challenges in interpreting self-reported health scores. The article proposes use of a personalised framework for gathering individual definitions of health and using this information to interpret clinical meaning of PRO data for an individual patient. We believe that this is essential if PROs are to provide informative and useful data to researchers, healthcare providers, regulators, and patients.

19-Sep-2018 17:01 Read more

Sanofi at the 2018 DIA Global Annual Meeting and Exposition

On Jun 24-28, 2017, one member of Sanofi’s Department of Clinical Outcomes Group (COG) attended the 2018 DIA Global Annual Meeting and Exposition, in Boston, MA, USA. It was a great opportunity to collaborate and problem-solve on global and local challenges facing the life sciences field.Emerging themes of the meeting included the opioid epidemic, artificial intelligence/machine learning/big data, patient engagement, and FDA updates on labeling and clinical outcome assessments.  Including patients in the drug development process; getting patient input on study feasibility and what is being asked of them during the study were noted as important during the DIA meeting.A new Ecosystem of Patient Advocacy Groups (PAGs) was recognized at the DIA annual meeting. Speakers from the PAGS noted it is especially important to ensure privacy/confidentiality of patient information and to allow patients the option to withdraw at any time from a clinical trial (CT).The FDA is considering Consumer Brief Summaries (CBS’s); which would provide CT summaries for CT patient participants and to help all patients better understand the package inserts.FDA presented on the Development of Suitable COAs for Rare Diseases (RDs noting ‘there are numerous opportunities to use suitable COAs to assess symptoms, signs, and impacts of RDs that are important and relevant to patients and to support endpoints to measure clinical benefit’.FDA recommended the 2009 PRO guidance for industry and the Roadmap to PRO measurement in clinical trials as guides to aid in the selection, modification, development, and evaluation of COAs.FDA noted COAs that are developed and used in clinical practice are not necessarily suitable for regulatory purposes (reliability and validity in target population needs to be established).Matt Reaney, Head of the Sanofi COG will be presenting at the forthcoming DIA workshop “Advancing the Science of Study Endpoints’ Sep 20-21, 2018 in Bethesda, MD.

08-Aug-2018 16:41 Read more