Goal of this presentation will be to provide an overview of the background on Post Authorisation Safety Studies (PASS) and assessment of effectiveness of RMMs. Presenting the description of real-world data (RWD) and how they are used in PASS the following key points will be covered:
• Almost half of PASS use a secondary data capture design
• Secondary data include Electronic Medical Records (EMR), administrative data, claims data and other data that are routinely collected by physicians and healthcare institutes. On-site retrospective chart reviews are also largely used to assess effectiveness of RMMs.
• Description of types of RWD.
Presentation of case examples, of studies conducted where the main objective was to assess the effectiveness of RMMs by using different RWD, will be useful to explain in a practical way:
• The data collection and study execution process
• The study design and type of RWD used in the study
• The analyses and key conclusions
Finally, to complete the presentation at 360 degrees will be shared some of the challenges intrinsic to real-world research:
• Representativeness of data sources used in safety studies is a challenge that can addressed
• Missing data
Paola Nasuti is an Associate Principal working in the Global Real-World Evidence Solutions team at IQVIA and she is based in London. She joined the company in 2003 after spending few years working as a research scientist at Universita’ degli Studi di Camerino (Italy) and as a pharmacist in Italy and in the UK. Paola holds a Master degree in Pharmacy and she is currently a member of the UK General Pharmaceutical Council. She has attended different post-graduate courses including a course in Epidemiology and Medical Statistics at the London School of Hygiene and Tropical Medicine (London) and a course in Medical Statistics at the University of Reading. Over the past 10 years at IQVIA, Paola had the opportunity to lead teams in the design, development and delivery of large retrospective studies including Drug Utilisation Studies across multiple therapy areas. Paola speaks fluently Italian, French and English. She has co-authored several researches in peer reviewed journals and presented findings from retrospective studies at key international conferences such as the European Society of Cardiology conference, the European Stroke conference, American Society of Clinical Oncology conference, European Society of Medical Oncology conference and many others.