The use of real world data will be important in determining access to medicines in the future and the UK should embrace the opportunity of being a world leader in this area, a new report from the country’s pharma trade body says.
Launched last night during an Association of the British Pharmaceutical Industry reception, where new chief executive Stephen Whitehead gave his first public address, the report lists a number of advantages for considering real world data as well as recommendations for making this happen.
With growing emphasis on outcomes evidence and value, discussions on the use of real world data – data collected outside the controlled clinical trial – have increased. Indeed, earlier this year, the ABPI published guidance on the use of real world data to help industry demonstrate value.
According to the new White Paper on the topic, conducting real world studies in the UK will demonstrate the value of medicines and will benefit the NHS by aiding the development of new practices. “The conduct of real world studies presents a unique proposition to encourage the investment, innovation and the use of skills brought by the pharmaceutical industry in the UK… It maximises the use of resources, benefits patients and their compliance with taking their medicines, and facilitates collaboration between the pharmaceutical industry, researchers and clinicians… The collection and use of real world data can enable all parties to achieve their objectives and, ultimately, to maximise patients’ health gains.”
The use of real world data would also increase a patient’s access to new innovative medicines, the report says, adding that “the UK has a unique opportunity to become a centre of excellence for the collection and analysis of real world data to be used by healthcare decision-makers both in the UK and worldwide”.
In his speech, Whitehead mentioned the “obvious advantages” of using real world data. “The collection and use of real world data will potentially lead to a better understanding of conditions and treatments in a wider population. This will deliver benefits such as patients suffering fewer side effects, better management of chronic conditions and the avoidance of preventable hospitalisations. Real world data will provide us with the means for assessing the true value of a medicine – it will provide us with the opportunity to improve patient quality of life while reducing NHS costs.”
However, the report also notes there are a number of challenges in the current UK research environment that will need to be overcome and a strategy for change will be needed. A number of recommendations are listed in order for the country and industry to move forward, including: developing a tool kit for UK pharma companies to present the case to their global colleagues for collecting, analysing and using real world data in the UK; streamlining of the regulatory environment for the conduct of real world data studies; encouraging NHS partnership with the industry; and lobbying for the use of electronic health records as a basis for research capabilities.