PRIN 2022: Clinical Trials Data

11 agosto 2023

Progetto di ricerca di interesse nazionale Clinical trial data between privatization of knowledge and Open Science (CLIPKOS)

Ministero dell’Università e della ricerca PRIN 2022, Clinical trial data between privatization of knowledge and Open Science (acronym: CLIPKOS)


Clinical research produces enormous amounts of data. This especially in the pharmaceutical field during pre-clinical and clinical tests. These data represent an invaluable resource from multiple points of views: scientific interests in creating new medicines and pursuing progress and innovation in the health domain, the necessity to verify the studies carried out, the purely commercial approach on protecting the effort to obtain a marketing authorisation, and the public interest in access and disclosure. Access to this information is often severely limited by forms of exclusive rights and other forms of protection and control that persist on various.

levels and make it impossible to take (public) advantage of such important resources. On the contrary, Open Science (OS), Open Access (OA), findability, accessibility, interoperability, and reuse (FAIR) principles, transparency and flexibility needs and the creation of public databases push forward the implementation of accessible or open data.
The recent pandemic has tragically brought this problem to bear and in this application context there is currently a lack of clarity and knowledge among the different stakeholders in the legal, philosophical and ethical fields.

The project aims to investigate the interplay between privatization of knowledge by pharmaceutical developers and OS for clinical trial data from multiple perspectives.

The first objective of the research will be the comprehensive legal mapping of the regulatory framework for the protection of data in clinical research in the European Union (EU) legal system and in some selected Member States, including Italy, while briefly considering the international context. It shall be also examined if and how this scenario may be consistent with the instances promoted by OS and OA. The legal analysis uses a comparative methodology that takes into account the complex regulatory framework.

The second objective will be the investigation of the different policies adopted by the public agencies (Eurpean and national) on data access and governance.
Moreover, interdisciplinarity will be key to understanding a context that sees the intersection of different scientific fields. These theoretical approaches will then be combined with ethical and philosophical studies related to striking the balance between the fundamental rights to health and science with the exclusive rights.

Ample space will also be dedicated to case studies based on health and clinical data and offered by the CNR-IFAC scientists. Researchers will be able to understand how data is managed with special reference to the concept of research integrity, data reproducibility and the attitude of communicating science in an open and transparent way.

The ultimate goals of the research are to provide a set of policy recommendations, guidelines and proposals regarding the use and disclosure of clinical test data that balance privatization and OS interests.