Innovative Approaches to Real-World Evidence Generation: The Role of Italian Community Pharmacies
Author(s)
Michela Mantuano, Phd1, Corrado Giua, Phd2, Alessandra Ori, MSc1, Marco Forghieri, MSc1, Riccardo Cipelli, Phd1, Duccio Urbinati, PhD3.
1IQVIA SOLUTIONS ITALY S.r.l., Milan, Italy, 2Società Italiana di Farmacia Clinica, Cagliari, Italy, 3IQVIA, Real World Solution, Milan, Italy.
1IQVIA SOLUTIONS ITALY S.r.l., Milan, Italy, 2Società Italiana di Farmacia Clinica, Cagliari, Italy, 3IQVIA, Real World Solution, Milan, Italy.
OBJECTIVES: Observational studies conducted in community pharmacies are relevant for evaluating drug use in ordinary clinical practice, as well as for identifying self-medication behaviors and verifying prescriptive appropriateness. These studies allow the collection of large-scale ‘real-world’ data, offering a more comprehensive view than traditional clinical trials. Here, we describe the implementation of a new framework to conduct prospective observational studies from community pharmacies in Italy to understand the treatment pattern and patient reported outcomes in real-world practice.
METHODS: The proposed framework is based on the following principles: (1) the design of a unique protocol for the patient data collection and data analysis with detailed rules and proxies; (2) the engagement of pharmacies, experienced in the clinical research, in the network of the Italian Society of Clinical Pharmacy (SIFAC) ensuring national representativeness; (3) the submission and follow-up of study documentation to the Ethical Committee and to AIFA’s Registry of Observational Studies for pharmacological studies (4) the training of the selected pharmacies on the study protocol and patients’ recruitment; (5) the data collection, analysis and evidence dissemination.
RESULTS: With this innovative approach for observational study, we aim to produce clinical and burden evidence from community pharmacies on the medication history of the patients, their self-medication behaviors, and their relationship with the prescribing clinicians. The methodological approach is supported by the well-documented methodology accompanying a publication of Giua C. et al., 2023 and ongoing studies.
CONCLUSIONS: In the context of the new regulatory environment outlined by 8th August 2024 AIFA guideline, this framework outlines a robust methodological approach to conducting prospective observational studies in community pharmacies in Italy. The combination of unique protocol, qualified network of pharmacies and the partnership with SIFAC can contribute to generating real-world evidence to enforce a patient-focused perspective optimizing patient care and support the application of scientific claims.
METHODS: The proposed framework is based on the following principles: (1) the design of a unique protocol for the patient data collection and data analysis with detailed rules and proxies; (2) the engagement of pharmacies, experienced in the clinical research, in the network of the Italian Society of Clinical Pharmacy (SIFAC) ensuring national representativeness; (3) the submission and follow-up of study documentation to the Ethical Committee and to AIFA’s Registry of Observational Studies for pharmacological studies (4) the training of the selected pharmacies on the study protocol and patients’ recruitment; (5) the data collection, analysis and evidence dissemination.
RESULTS: With this innovative approach for observational study, we aim to produce clinical and burden evidence from community pharmacies on the medication history of the patients, their self-medication behaviors, and their relationship with the prescribing clinicians. The methodological approach is supported by the well-documented methodology accompanying a publication of Giua C. et al., 2023 and ongoing studies.
CONCLUSIONS: In the context of the new regulatory environment outlined by 8th August 2024 AIFA guideline, this framework outlines a robust methodological approach to conducting prospective observational studies in community pharmacies in Italy. The combination of unique protocol, qualified network of pharmacies and the partnership with SIFAC can contribute to generating real-world evidence to enforce a patient-focused perspective optimizing patient care and support the application of scientific claims.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA55
Topic
Patient-Centered Research, Real World Data & Information Systems, Study Approaches
Disease
No Additional Disease & Conditions/Specialized Treatment Areas