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

FDA and CTTI Workshop: Enhancing the Incorporation of Patient Perspectives in Clinical Trials

March 18, 2019COG team members attended the FDA workshop held on March 18, 2019 on Enhancing the Incorporation of Patient Perspectives in Clinical Trials. The workshop was held to discuss patient, caregiver, industry, academia and practitioner perspectives regarding the challenges and concerns facing patients participating in clinical trials, and to share best practices.  The meeting focused on the challenges and concerns facing patients.  Some of the main themes/messages that emerged were to include patient perspective earlier in the drug development process and throughout the product lifecycle (consider patients as partners in the process), to ensure concepts that matter to patients are included when assessing the value of the products, especially regarding treatment and disease burden, and to more fully share information with patients who participate in clinical trials in lay language and in a timely fashion without jeopardizing or invalidating a study. Some patients expressed concerns about how to select/navigate clinical trials they might be eligible for, or when learning they are not eligible to a clinical trial due to exclusion criteria such as comorbidities, pre-existing conditions  or because too healthy. The patient testimony by and on behalf of patients was powerful and called for relaxed eligibility criteria in cases where patients are out of treatment options. Theresa Mullin from FDA said that for all future studies we need to ensure concepts that matter most to patients are captured using standardized measures, to use more historical controls if and when possible, to quicken research timelines, and to relax inclusion/exclusion criteria while not compromising the integrity of the trials that could benefit both the research sponsors and the patients. The workshop was held as part of an FDA commitment included in PDUFA VI (the sixth authorization of the Prescription Drug User Fee Amendments of 2017). A link to meeting including agenda, presentations, and full recording of the meeting can be found here:

03-Apr-2019 11:09 Read more

Patients as key Partners for our clinical trials: doing things differently!

The Sanofi Clinical Outcome Generation team participated to the 3rd annual Patients as Partners Europe conference in London, which focuses on patients’ involvement throughout the entire medicines development life cycle to drive greater efficiencies in clinical research.All sessions emphasized the essential role of patients as experts of their disease to improve clinical research during the whole medicine life cycle development.The new Patient-Focused Medicines Development guidance was presented to highlight how and when patient engagement is impactful when using robust methodology, more than 150 activities with patients were identified.Many pharma case studies were presented on how patients were involved in clinical development and trial initiatives, how patient input was implemented, challenges faced and outcomes resulted from these initiatives. In most of these presentations, patient organizations, patients and carers were on the podium to share their specific and meaningful experience.Some specialized service companies were also present to share how we can improve patient recruitment and retention in clinical trials by bringing solutions to patients’ home rather than the traditional model at sites.This was a full 2-day conference to make us think and work differently, not only FOR but WITH the patients!

07-Feb-2019 15:22 Read more

A new PRO questionnaire for acceptance of subcutaneous injectable treatment: the Injection-Treatment Acceptance Questionnaire (I-TAQ)

Sanofi is proud to announce the availability of the Injection-Treatment Acceptance Questionnaire (I-TAQ) patient-reported outcome (PRO) questionnaire, developed in collaboration with Regeneron Pharmaceuticals Inc., and evaluating treatment acceptance with a subcutaneous injection therapy. This questionnaire was developed with patients at high cardiovascular (CV) risk who had experience of self-administering their treatment for lowering low-density lipoprotein cholesterol (LDL-C) via subcutaneous injection, and items are generic enough to be used for any adult patients using subcutaneous injections. Its development and validation have met high methodology standards as outlined by the FDA (FDA PRO guidance, Dec. 2009).  Following a literature review, concept elicitation interviews were conducted with 29 patients and then cognitive debriefings. The i-TAQ includes 22 items grouped into five domains of Perceived efficacy, Acceptance of side effects, Injection self-efficacy, Injection convenience and Overall acceptance. During its psychometric validation, it was found to be a reliable and valid instrument in high CV risk patients using a subcutaneously administered treatment for LDL-C lowering. Developed in US English, it was also linguistically validated in more than 35 languages. Please visit the i-TAQ page for detailed information !

30-Nov-2018 08:48 Read more