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Promise of Real World Data Through a Learning Healthcare System

Use of real world data would complement the traditional evidence from randomised clinical trials
08 Oct 2018
Bioethics, legal and economic issues

Real world data 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 real world data 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 real world data 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 real world data 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’.


Eichler H-G, Bloechl-Daum B, Broich K, et al. Data rich, information poor; can we use electronic health records to create a learning healthcare system for pharmaceuticals? Clinical Pharmacology & Therapeutics; Published online 4 September 2018. DOI: https://doi.org/10.1002/cpt.1226

Last update: 08 Oct 2018

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