Optimization of clinical research in Italy: the programmatic instances of the CARE Project

Introduction and objectives: Clinical research is a strategic priority for the Italian healthcare system, with significant benefits for patients, economy and public health. The Clinical Advancement & Research Excellence (CARE) project identified the main obstacles that limit the full expression of the potential of clinical trials in Italy and proposed concrete solutions. Methods: Starting with an online survey and following a simplified Delphi method, a multidisciplinary panel of experts identified the main barriers to clinical research in Italy and proposed a set of programmatic instances designed to improve the present situation. The final instances were formulated also based on the review by external stakeholders. Results: The following programmatic instances were developed: 1) support the compliance with trial contract signing times; 2) create a national standard for Clinical Trial Sites (CTS) and a dedicated portal; 3) define the role of General Practitioners; 4) promote campaigns to raise awareness on the importance of clinical research. Conclusions: The instances presented offer concrete insights to optimize the effectiveness and efficiency of clinical trials in Italy, ensuring international competitiveness and allowing patients to benefit from innovative therapies.