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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Latest News

A new PRO questionnaire developed in statin intolerance (Statin Assessment Experience Questionnaire- SEAQ)

Sanofi is proud to announce the development of a novel patient-reported outcome (PRO)  in collaboration  with Regeneron Pharmaceuticals Inc. that evaluates patient-centric attributes of statin intolerance in real-world setting. This  brief questionnaire (15 items) was developed for patients with  hypercholesterolemia that are at moderate, high or very high cardiovascular risk  allowing them to foster a communication with their physicians regards their statin intolerance. Its development has met high methodology standards as outlined by the Food and Drug Administration (FDA)(FDA PRO guidance, Dec. 2009).  Following  an empirical literature review and perspectives from physicians and nurse practitioners, concept elicitation interviews were conducted with statin treated patients. Their symptoms and associated impacts were identified and selection of concepts for measurement and the construction of the questionnaire were determined. The questionnaire content was then subsequently tested for relevance, comprehensiveness, and suitability for use in real world. The psychometric analyses, including interpretability of scores is currently under investigation. This new PRO questionnaire is a welcome addition in cardiovascular field where statin intolerance  needs better understanding  from the patient perspective. Please visit the SEAQ page for detailed information !

24-Aug-2017 09:43 Read more

FDA outlines plan for development of guidances related to patient-focused drug development

In recent years the US Food and Drug Administration (FDA) have increasingly emphasised the importance of gathering the patient perspective in understanding disease and the potential benefits and risks of medications under development. Under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA formalized the systematic gathering of the patients’ perspective through patient focused drug development (PFDD) meetings, of which 22 have been held to date. Under the recently approved 21st Century Cures Act, the FDA will further develop guidances regarding the collection of patient experience data, and the use of such data and related information in drug development. These guidances will outline the elicitation of information on disease status, impacts, and treatment experience, and the measurement of these in a standardized way which is clear, reliable, valid and responsive. Specifically, the 21st Century Cures Act requires that the guidances outline appropriate, relevant and objective methodological approaches to collecting patient experience data and identifying what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease; approaches to identifying and developing methods to measure impacts to patient, including clinical outcome assessments (and patient-reported outcomes [PROs]) for purposes of regulatory decision making; and how such information will be used in the structured risk-benefit assessment framework.The FDA plans to develop several guidances within the next five years, including ones to “describe approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy”, “describe processes and methodological approaches to development of holistic sets of impacts that are most important to patients”, “describe approaches to identifying and developing measures for an identified set of impacts which may facilitate collection of meaningful patient input in clinical trials”. A guidance on clinical outcome assessments which will revise or supplement the 2009 PRO guidance will also be developed in draft format by the third quarter of 2020.These guidance documents, coupled with ongoing PFDD meetings, will help to ensure that patients are engaged throughout drug development and evaluation, and will provide clarity in the regulatory expectations from drug manufacturers. We anticipate that the role of PROs will be emphasised in order to collect quantitative (and qualitative) data directly from patients, and that they will play a more central role in regulatory decision making, which will serve to enhance the patient-centric nature of drug approvals.Table 1 in the FDA release provides a summary of key steps FDA will take in developing these guidances over the next five years:

13-Jul-2017 09:20 Read more


Health Technology Assessment International (HTAi) is a global scientific and professional society for researchers, agencies, industry, academia, health service providers and patients/patient representatives who produce, use, or encounter, HTA to support optimal policy- and decision-making. The 14th Annual meeting took place in Rome on June 17-21 2017. Although the congress largely focused on epidemiology, health economics and modelling, there were some key sessions exploring timing of, and methods for, gathering and using the patient-, and societal-perspectives in HTA decision making. Sessions such as “Patient Involvement in HTA: Why, When and How”, moderated by Karen Facey from the University of Edinburgh, “Will the Patient-Centric Approach of Value-Based Health Care Drive Innovation in HTA?” moderated by Liesl Strachan from Medtronic, and “How to Measure Patient Preferences and Engage Patients in Value and Access Processes” moderated by Isabelle Moulon from the European Medicines Agency presented an overwhelmingly consistent message; that various perspectives need to be accounted for in the way that pharmaceutical drug development is conducted, and that patients, patient representatives, and society have a vital role in helping shape that development so as to generate outcomes which matter most to the users of the medicine.Achieving this goal requires us to think beyond the traditional paradigm of pharmaceutical drug development so as to collect “real world” data, and to systematically incorporate numerous perspectives when designing research projects. Systematically gathering representative and generalizable patient and societal views is an important part of this and requires expertise in both qualitative research and quantitative research methods. Specifically, Patient Reported Outcome Measures (PROMs) will be a central part of this movement, but we need to acknowledge that people can only respond to the questions they are asked in PRO research. A supplemental qualitative component will help ensure that we are better able to contextualise the quantitative PRO data, and provide additional relevant information unrelated to the study outcomes per se, including study experience and potential use in routine practice.

27-Jun-2017 09:56 Read more