Patient Engagement in Research and Development Processes of Biotech Firms

Although the issue of patient engagement has been debated for several years, research in the health sector continues to be mainly conducted on patients, seen as a source of data, and not with patients, considering their active contribution in the research process. The concept of patient engagement implies the need for integration between scientific competence regarding a given illness and knowledge based on the direct experience of the illness itself. In this sense, patients should be involved in the identification of health priorities/outcomes. The concept of patient engagement is interpreted in different ways. This fact can create confusion and impasse in practicing patient involvement in medical research. The aim of this article is to begin a deconstruction of the complexity of this concept. This work is based on data collected through a series of qualitative interviews with R&D directors of biotech companies and representatives of patient associations in Italy. Italian biotechnology companies interpret patient engagement as patient centricity, an organizational model that includes the patient's experiential knowledge in research and development processes. This means passing from an illness-centred model to a patient-centred one, and, consequently, interacting constantly with the regulatory agencies and their request for a result produced accordingly. Nevertheless, many factors contribute to the spread of skepticism regarding patient engagement in many pharmaceutical industries: uncertainty about patients’ ability to contribute to research, additional costs, slowdown and interference with the research process, uncertainty about how to resolve conflicts, confusion about how to implement a patient-centred approach, uncertainty about the financial value that patient centricity provides. So, patient engagement is often limited to participation, clinical trials, or education about a new drug using health professionals as proxies. The interrelation between regulatory agencies, patients and industries is shaping the contemporary healthcare research and development landscape. Each of them in various forms is involved in a process of organization and change of perspective. Nevertheless, there are no common or shared protocols or best practices, and the initiatives of companies and patient organizations are generally sporadic and inconsistent, which limits their effectiveness. In the Italian context, as in all Western countries, patient participation is seen as a fundamental process, but its implementation is still a learning by doing performance.