An updated version of the White Paper on academic clinical research, which was initiated by EORTC and written in cooperation with the BioMed Alliance, of which ERS is a member, has been published in the European Respiratory Journal.
The paper discusses ways to restructure the process of clinical research to bridge the existing gap between market approval and real-life clinical practice and maximise the potential of precision medicine, the objective being to better serve the needs of patients and generate the data needed to inform clinical practice.
The authors highlight among others the following key areas:
- Infrastructural gaps in the drug development process and the regulatory environment, which lead to waste of knowledge and resources
- Necessary conceptual changes, from focusing to bring a product to the market to integrating a new treatment in the existing therapeutic strategies and taking into account its impact on the patient journey
- Need for Europe-wide clinical population-based registries to support these changes
- Patient involvement at each strategic level in health research to truly serve their needs.
The paper argues that a holistic approach to the development of therapeutic strategies is required in order to unlock the potential of precision medicine, and concludes by calling out European Institutions to activate these changes.