Introduzione
Very often in Real World research the clinical "study" (i.e. scientific research aimed at investigating a specific phenomenon) is distinguished from the corporate "project" (i.e. the business) which determines the conception and financing of the study itself. In traditional clinical trials, the link between the 'study' and the 'project' is always crystal clear since both have the same objective: to verify and possibly prove the clinical value of the product in contrast, in pre- and post-marketing observational studies, the study's objectives do not always coincide with the project ones. For example, a study designed to assess the quality of life of patients suffering from a particular disease may be funded within the context of a project whose general objective is to highlight the impact of the disease. In this case, the goal of the study and the aim of the project, although having a synergistic interaction, are not fully the same.
This phenomenon, known as the "study-project dualism", implies the need for a careful and strategic design phase, which must necessarily begin well before the design and organisation of any observational clinical research and which must involve all company stakeholders from the various departments involved in product development: clinical R&D, marketing, market access, medical affairs, clinical operations, pharmacovigilance, etc.
Although all this may seem trivial, the reality is that following these principles is very complicated due to organisational (silo structure) and cultural barriers, as well as the different skills and technical languages present in any large corporate organisation. Added to this is the complexity of involving other key stakeholders outside the organisation, such as regulators, medical staff and even patients and their caregivers, at the most appropriate times and in the most appropriate ways.
This course aims to illustrate a well-established methodology through its critical application in designing dozens of successful observational studies. It will help you overcome obstacles and perfectly match your study and project objectives.
MODULE 1
Agreement on methodology and definitions
The strategic use of RWD in the pre- and post-marketing phases of a product
The strategic design phases: from the strategic need to different study scenarios
MODULE 2
Agreement on ethical approval processes
From strategy to study: how to combine business objectives with ethical and scientific objectives in clinical research
The executive design phases: from study scenarios to the concept sheet
The course is recommended for those in decision-making and coordinating roles in Medical Affairs, Clinical Research, Real World Evidence Generation who must design pre- and post-marketing studies using observational methods to support corporate product development and promotion strategies. The course may also interest curious professionals working in other corporate functions (Marketing, Market Access, Patent Advocacy, etc.) who wish to explore observational clinical research’s fascinating but complex world.
Participant experience
Familiarity with clinical research is recommended
Highly interactive teaching and discussion of real cases.
Docente/i
Giovanni Fiori
He holds a PhD in the Biology of Human Populations and a master’s in public health. Since 1994 he has conducted epidemiological research as part of international cooperation programs in Central Asia led by the University of Bologna. In 2003 he was the founder, president (until August 2018) and scientific director (until March 2022) of Medineos (formerly MediData Studi e Ricerche) where, in addition to developing the business, he was responsible for defining the strategy for designing and conducting more than 150 local and international Real World multi-centre observational studies for the pharmaceutical industry and non-profit organisations. Together with French, German, Czech and Spanish colleagues, he was one of the founders of the European observational research network WellCRO. From 2018 to 2022, following the entry of Medineos into the IQVIA group, he also held the position of Senior Principal Observational Study in the Italian branch. Since 2005 he has been the coordinator of the “Observational Studies and Real-World Evidence” Working Group of the Italian Society of Pharmaceutical Medicine (SiMeF, ex SSFA), where he was also a board member of directors. At the European level, he was responsible for the “Late Phase” working group of the European CRO Federation (EUCROF). He regularly teaches the Master of Clinical Research at the Bicocca University of Milan. Invited as a speaker at various congresses & conferences, he is the author or co-author of over a hundred articles and scientific communications.
Online Training – 2 modules
MODULE 1 | 30 November 2023 from 9 am to 12 pm CET
MODULE 2 | 04 December 2023 from 9 am to 12 pm CET
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 660,00* (until 7 November 2023)
Ordinary: € 850,00*
Freelance – Academy – Public Administration**: € 425,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.