Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice. However, to realise the full potential of RWD requires a ‘learning healthcare system’, write the European Medicines Agency’s (EMA) Executive Director and Senior Medical Officer, as well as heads of three national EU agencies, and academia, payer, and Organisation for Economic Co-operation and Development (OECD) representatives, in a paper published in Clinical Pharmacology and Therapeutics.

A ‘learning healthcare system’, based on electronic health records and other routinely collected healthcare data, would allow RWD to be continuously fed into the system, ensuring that with every new patient treated, we know more overall about the practice of medicine.

Such judicious use of RWD would complement the traditional evidence from randomised clinical trials, for  the benefit of all stakeholders involved in the development and use of medicines, from patients and healthcare professionals to regulators, health-technology assessment bodies, payers, academic researchers and research-based pharmaceutical industry. The authors highlight the need to tear down the current barrier between the structured research setting and everyday medical practice, and instead use data gathered in everyday practice to generate new knowledge and answer research questions.

To achieve this, the healthcare systems must be ready in terms of technology to collect data, of a methodology to analyse information and governance in particular regarding aspects such as protection of personal data, consent, ethics and data access.

The authors therefore call for all stakeholders to join in a coordinated effort, at international level, to accelerate the implementation of such a model of a ‘learning healthcare system’.

Posted on the EMA website on 27 September 2018