In the current healthcare environment, bringing a new drug to market requires not only to gain regulatory approval, but also a favourable decision from payers and health technology agencies. With the development of novel sophisticated health technologies and targeted therapies, clinical research has become more complex, time consuming, and costly. In parallel, there is a need to generate a larger amount of clinical evidence (including from the real world) to establish the safety, efficacy, and comparative effectiveness of innovative medicines for achieving regulatory approval and market access. Given the need to conduct more clinical trials, and more efficiently, the pharmaceutical industry has begun the modernization of its traditional model for drug development by integrating value-added innovative solutions to its clinical research platforms.
To support this transformation, the EHR4CR (Electronic Health Records for Clinical Research) project has innovated beyond the state-of-the-art by developing a robust technological platform which, for the first time, will enable the trustworthy reuse of patient-level data from Electronic Health Records (EHR) for clinical research in Europe, and beyond. EHR4CR will revolutionize how clinical research will be conducted in Europe by facilitating 3 main clinical research scenarios that will enhance and speed up clinical research processes, and the delivery of innovative medicines to healthcare. In addition to attracting more R&D investments in Europe by enabling more efficient clinical research, significant benefits are expected from EHR4CR solutions. To assess the added value for pharmaceutical industry, a robust cost-benefit assessment has been conducted.