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A vision for world leadership in real world data

The UK should exploit the potential of real world data—information collected in clinical practice while developing a medicine—for which it should become a centre of excellence, the Association of the British Pharmaceutical Industry has said.

The ABPI published a white paper, “The vision for real world data—harnessing the opportunities in the UK”, on 8 September.

RW data is different from clinical trial data in that it samples what actually happens in clinical practice and demonstrates the value to a patient of a medicine or technology.

The report said that although clinical trial data had historically been used when deciding whether medicines should reach the market, there was a growing recognition of the “role played by data about patients’ use of medicines in normal clinical practice”.

The ABPI argued that RW data therefore played an important role in ensuring fair access to innovative medicines and stressed that RW data studies were cheaper to set up than clinical trials.

The UK, it said, was in a good position to become a world leader in the field, but several measures were needed to reach that point.

Goals included lobbying for the need for change in the approval processes, skills and capabilities, and acceptance of RW data; “streamlining” the regulatory environment for RW data studies; improving incentives for NHS centres to participate in such studies; and securing investment in developing research capabilities based on UK electronic health records.

Research regulatory and governance frameworks, it said, contained clauses that appeared “unnecessarily restrictive when compared to the risks and benefits of RW data studies, and which inhibited their conduct.

“This report describes a UK pharmaceutical industry already well placed to adapt to the growing demand for RW data to demonstrate the value of its medicines to healthcare decision-makers around the world,” said the report.

“In order to capitalise on this position it will be necessary to develop, maintain and share RW data capabilities across the pharmaceutical industry to ensure the appropriate internal skills, processes, resources and standards are available to underpin the strategic development and practical implementation of RW data programmes.”