The BigMed project has as part of the project goals, addressed the challenges and barriers related to implementation of precision medicine, including real-world evidence (RWE), in clinical practice. This includes sharing of genomic data to be used for development of automatized decision support to improve accurate diagnostic work. However, the issue of how these genomic data and other real-world health data can be used in a clinical trial setting in the future of precision medicine and patient centered health care has not yet been addressed in the project. In randomized clinical trials (RCTs) subjects are divided by chance into separate groups to compare different treatments or interventions. Today, RCT are challenged by the introduction of precision medicine which relates to the broader concept of patients-centered healthcare and innovation. This can be seen as a paradigm shift going from a "one size fits all" mindset to a setting where the treatment is tailored to the individual patient, and will pave the way for the next generation of clinical trials. As part of this paradigm shift, next generation sequencing (NGS) is emerging as a powerful and essential tool to stratify and enrich patient groups in clinical trials based on their genomic profile. The big-data revolution in health care with the growing amount of real-world data through electronic health records (EHR) and digital technologies such as wearables and apps, is also driving the demand for new paradigm. To address the challenges and barriers associated with the new paradigm and as part of the road map to precision medicine we want to arrange a seminar that brings together stakeholders with different backgrounds, interests and positions to cover the clinic, governance and industry aspects. Specifically, we want to address how challenges and barriers identified in the BigMed project affect the implementation and conduction of clinical trials with a precision medicine focus in Norway.
Project leader: Anne Jorunn Stokka
Institution: DNV AS