By Simon Ruini
Since 2007, all major stakeholders involved in the development, marketing, authorisation and use of pharmaceutical products have felt the need for a change of their interaction and approach to the current system in Europe and especially in the UK.
Each of these stakeholders have different priorities and interests: the Government needs primarily to reduce the cost of NHS and some of its inefficiencies, Pharma Companies need to find new ways to protect their branded products and also to significantly reduce the cost of clinical development, Regulatory Authorities look forward to a harmonised and consistent legislation and attribution of responsibilities, Patients want to have an easier access to healthcare as a whole, and Medics wish to be allowed a professionally qualifying approach in the choice of therapy for their patients.
All these goals will hardly be accomplished at the same time and comprehensively, but the need for a major change is now acknowledged by everyone. At the same time, there is awareness that a major change will have a great impact on all areas of pharmaceutical and healthcare arena including innovation, research, market competitiveness and overall healthcare standards of the countries involved.
In this context, the UK was the first country worldwide to take formal actions starting a series of consultations between the parties. In late 2008, the ABPI’s innovation campaign kicked off with a series of projects which were aimed at looking at the innovative potential of the UK, as a place for investment in life sciences. As part of this initiative, the Real World Data campaign team were tasked with appraising the UK’s strengths in demonstrating the value of medicines using Real World data i.e. data obtained by any non-interventional methodology that describes what is happening in normal clinical practice. The data about patients’ use of medicines in normal clinical practice, or in settings which reflect the reality of health care delivery, was becoming increasingly important in decisions affecting patients’ access to medicines in the UK.
Real World Data is an initiative that does not intend to underestimate the importance of ‘evidence based medicine’ as generally referred to by ‘the use of statistically proven results from randomised, controlled clinical trials’, but rather to complement it with additional value derived from decades of collected data and the experience that can be drawn from real settings. Real World Data is a broad term which has been used to describe a variety of data types including data gathered in large randomised observational registries, comparative effectiveness studies and pragmatic trials through to local single centre audits or service evaluations. Real World Data is data which describes what is really happening in everyday normal clinical health care practice. This can include data from existing secondary sources (e.g. NHS databases) and the collection of new data, both retrospectively and prospectively.