During the past decade, there has been a strong focus on patient-centric initiatives in support of drug development planning and execution by health authorities.¹ One recommendation is to include an evaluation of patient-reported treatment satisfaction in study design and to use the resulting data to inform treatment decisions.²

In support of this guidance, several Patient-Reported Outcome (PROs) have been developed. One of the most widely used PROs is the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is based on the conceptual framework of treatment satisfaction and has evolved over time into three questionnaire versions that can be used to assess the patient's perspective on treatment experience and related satisfaction.³

In commercial settings the value of PROs is largely considered in terms of potential for securing a labeling claim in the USA or inclusion in the summary of product characteristics in Europe. TSQM is used to support medical product labeling claims approvals and to assess the patient value of pharmaceutical intervention.

Join IQVIA's Patient Centered Solutions (PCS) panel of experts as we address the following topics:

1. Understanding the important role of treatment satisfaction in clinical trial development:
• How is treatment satisfaction translated in clinical trials?
• Different ways to capture treatment satisfaction in patients.
2. Explaining Treatment Satisfaction Questionnaire for Medication (TSQM) as a reliable tool in a clinical setting:
• TSQM development: content validity and psychometric properties
• TSQM evolution: 3 versions that cover patient perspective on treatment experience.
3. Application of TSQM results to support medical product labeling claims approvals:
• Practical case studies that reflect the importance of TSQM in assessing the patient value of pharmaceutical interventions.

¹Patient-Centric Product Development: A Summary of Select Regulatory CMC and Device Considerations | Elsevier Enhanced Reader. https://doi.org/10.1016/j.xphs.2023.01.029.

²Research, C. for D. E. and. Patient-Focused Drug Development: Methods to Identify What Is Important to Patients. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-methods-identify-what-important-patients (accessed 2023-05-19).

³Rodriguez, A. M.; Gemmen, E.; Minton, A. P.; Parmenter, L. Satisfaction With Treatment.

Speakers:

Alexandra Palmer Minton
MA, Associate Director, Instrument Services, Patient Centered Solutions, IQVIA

Carolina Navas
PhD, Scientist, Instrument Services, Patient Centered Solutions, IQVIA

Ana Maria Rodriguez
PhD, MSC, PT, Director, Global Lead RW and Preference Practice, Patient Centered Solutions, IQVIA