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 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

Sanofi at FDA Patient Focused Drug Development Public Workshop to provide input on Methods to Identify What is Important to Patients and Methods to Select, Develop or Modify a Fit-for-Purpose Clinical Outcome Assessment

On Oct 15-16 2018, Sanofi colleagues from the Global Clinical Outcomes and Risk Benefit and Epidemiology teams attended the Patient Focused Drug Development (PFDD) Public Workshop at the FDA in Silver Spring, MD.The purpose of the meeting was to obtain feedback from stakeholders on two FDA Guidance documents in development under the PFDD initiative entitled  Methods to Identify What is Important to Patients (Guidance Document 2) and Selecting, Developing or Modifying a Fit-for-Purpose Clinical Outcome Assessment (COA) (Guidance Document 3).Representatives from all divisions of FDA (CDER, CDRH, CBER), the Pharmaceutical and Biotech Industry, Public/private partnerships, Academia, Patients and Patient Advocacy Groups were represented to provide input on: Standardized nomenclature and terminologies for patient-focused drug development Methods to collect meaningful patient input throughout the drug development process Methodological consideration for data collection, reporting, management, and analysis of patient input  One of the key questions that was discussed and debated over the 2-day meeting related to the target audience for the guidance documents—specifically whether the guidance documents should be targeted at scientists working in the field of PFDD or at a broader audience. While the emphasis on robust measurement would not change the level of technical detail would differ.The FDA is particularly interested in feedback on the presentation of the text/tables, examples regarding what has worked, what has not worked (lessons learned), how sponsors have modified a COA and how to best estimate clinically important changes at the individual level.Sanofi will offer a response to assist FDA in finalization of these important guidance documents.

26-Oct-2018 14:24 Read more

Important discussions at the Drug Information Association (DIA) Study Endpoints Community conference, 2018

The 2018 DIA Study Endpoints Community conference was held in September in Bethesda, Maryland. The conference brought together health care professionals involved in the selecting, developing, analysing, and interpreting of study endpoints. The focus was on advancing the scientific development and evaluation of study endpoints and educating other health care professionals about these developments. The congress agenda was broad, but all sessions emphasised patient-centricity, which has afforded significant innovations in how patients can be involved in endpoint development and selection in the past few years. Of particular interest was discussion around whether regulatory, payer and patient perspectives on the value of study endpoints can align, and whether core outcome sets for consistent measurement and analysis would facilitate this alignment. Core outcome sets are being developed by numerous organisations, including the Center for Medical Technology Policy (CMTP) and the International Consortium for Health Outcome Measurement (ICHOM) and recently the FDA send a request for information to facilitate their consideration of the value of core outcome sets in certain disease areas. It will be interesting to see how this develops, and the central role of patient-reported outcome (PRO) measures in these. Another topic discussed in detail – and resonating with the Sanofi team - was the importance of measuring positive well-being; something which is rarely done. Rather we focus on the absence of negative well-being, which of course is not the same thing at all.

02-Oct-2018 17:03 Read more