Enabling RWD-driven drug development accelerates the approval of more effective and affordable treatments. This approach successfully identifies patient patterns and density indicators and maps causal pathways.
By allowing study teams to design and conduct more inclusive and/or relevant studies, real-world data can enhance the standard of care and ultimately improve patient outcomes.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Liberating the genetics, laboratory and pharmacy data that sits deep within healthcare subsystems, while protecting patient information and navigating the global regulatory landscape, is no easy task but would greatly help in the treatment of diseases.
The researchers wrote that RWE could complement trials, but that observational methods are unlikely to take away the need for traditional clinical studies.
Parexel, one of the largest CROs in the world, said the partnership would involve connecting real-world data across the clinical trials it conducts.
Aetion President Jeremy Rassen said in an interview on the sidelines of the CB Insights Future of Health conference that rare diseases and Phase IV safety studies would be examples of situations better suited to real-world evidence.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.