On 17 September 2015, the Academy of Medical Sciences, in partnership with the Association of the British Pharmaceutical Industry (ABPI), held a workshop on ‘Real world evidence.’ The workshop, chaired by Sir Alasdair Breckenridge FMedSci, comprised participants from across industry, regulatory, academia and policy, and aimed to explore:
How real world evidence might contribute to regulatory and HTA decision-making.
Aspirations and opportunities for future use of real world evidence in a regulatory context.
The acceptability of real world evidence, challenges to acceptability and steps to overcome these.
Over the course of the morning session, speakers from the MHRA, EMA, FDA, NICE, ABPI and the IMI GetReal initiative presented their perspectives on real world evidence and the work that each of their organisations is engaged with in this area.
Participants discussed where real world evidence, in certain circumstances, may have advantages over randomised clinical trial data with the potential to provide verifiable real-time data from routine clinical practice; thus with the potential to stimulate a paradigm shift in the way that we evaluate medicines. Real world evidence is already utilised for safety monitoring, and delegates considered how we bridge the gap to apply learnings from post-marketing safety surveillance to better assessment of efficacy and effectiveness using real world evidence.
During the afternoon break-out sessions, participants discussed their aspirations for the use of real world evidence for regulatory decision-making in 2020, barriers to these aspirations and practical steps to overcome these barriers. Key challenges identified included:
Terminology, as stakeholders are still applying the terms ‘real world evidence’ and ‘real world data’ differently.
How we coordinate activities across real world evidence generation and use to create standards and guidelines, from data collection and repository to methodologies and applications in a regulatory context.
Public and patient engagement.
Understanding and communicating the value proposition of real world evidence at all levels to the regulator, health technology assessor, payer and patient.
A video from the workshop can be found here. A report of the workshop will be published in due course.
The Academy of Medical Sciences’ FORUM was established in 2003 to recognise the role of industry in medical research, and to catalyse connections across industry, academia and the healthcare sector. Since then, a range of FORUM activities and events have brought together researchers, research funders and research users from across academia, industry, government, and the charity, healthcare and regulatory sectors. Further information and details of future events can be found on the FORUM homepage.
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK. Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases. The ABPI is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.