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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areas in which Sanofi has developed
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.

24-May-2018 13:49 Read more

Ninth Annual Patient-Reported Outcome Consortium Workshop, April 25-26, 2018, Silver Spring, MD

Sanofi Clinical Outcomes Generation team members participated at the Ninth Annual Patient-Reported Outcome Consortium Workshop, April 25-26, 2018, Silver Spring, MD. The meeting brings together industry, FDA, Critical Path Institute members, consultancies and those interested in COA measurement/issues. Highlights of the meeting included FDA update on their role as an active participant in drug development, broadening their traditional regulatory role. Also an update on expanded efforts to enhance drug development with four main areas highlighted: 1. Patient Focused Drug Development (collect and analyze patient experience data, in order to use in designing drug development programs (endpoints in studies/design studies), use to support regulatory decision-making (risk/benefit considerations); 2. Novel innovative trail designs (use of complex and adaptive and other novel trial designs – and how such clinical trials can satisfy the substantial evidence standard); 3. Real World Evidence (use data regarding use or potential benefits and risks of a drug derived from sources other than randomized clinical trials – in support of new indications and post-approval study requirements); and 4. Drug Development Tools: biomarkers and COAs. The COA Qualification Program was discussed with presentations from FDA and of therapeutic working groups that have developed and qualified COAs. Five guidance documents FDA working on were also discussed; these include Guidance 1: Identifying research questions and developing a sampling strategy to collect representative patient input: operationalizing data collection, management and analysis (Dec 18, 2017 Workshop); Guidance 2: Methods to elicit detailed, unbiased and comprehensive input from patients, patient groups and caregivers (Patient experience and patient preferences will inform what and how to measure, how to use COA clinical trial data in regulatory reviews); Guidance 3: developing or identifying COAs (still under development) fit for purpose COAs, Using patient input to develop appropriate COAs for use in clinical trials; Guidance 4: Developing COA-related clinical trial endpoints based on patient input; interpreting these endpoints (interpretable, important); Guidance 5: developing guidance on guidance; topic of guidance to develop and submit proposed draft guidance relating to patient experience data. Details of workshop including meeting transcript and slides to be posted by May 30, 2018 at:

18-May-2018 12:31 Read more

The 5th Winter Symposium of the Human Motion Project

On March 7th 2018, Sanofi’s PRO Team attended the 5th Winter Symposium of the Human Motion Project. The vision of the project is to improve human health by an open collaborative technology platform for the mobile medical monitoring of human motion. The 2018 symposium focused on novel endpoints generated by mobile accelerometry for use in clinical trials. PRO research has highlighted the significance of reduced physical capacity to patients with chronic illness. Accelerometry is a technique for objectively quantifying movement patterns during walking and has more applicability in the real world compared to more traditional gait analysis or laboratory-based testing environment. However, its use in clinical trials has been restricted by questions around its sensitivity, specificity, precision and algorithms for analysis, as well as a lack of standardization of endpoints. The 5th Winter Symposium of the Human Motion Project included presentations and discussions focused on these topics. Specific topics included defining standards in accelerometer implementation and endpoints, testing of new algorithms for step detection and speed estimation, and linking accelerometer data to hard morbidity and mortality outcomes.This is an important area for the future of clinical research and we are excited about developments allowing for more mainstream use and consistency in specification and interpretation.

12-Mar-2018 14:15 Read more