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.
