SPRU - Science Policy Research Unit

Screening for cancer in the post-genomic era

How do new diagnostic tests find their way into practice? A new European Research Council funded study, involving Dr Michael Hopkins, Dr Daniele Rotolo and Dr Frederique Bone at SPRU, looks at the changing role played by diagnostics firms in bringing new technologies into routine clinical practice.

The project - titled 'CANCERSCREEN: Screening for cancer in the post-genomic era' - is led by Dr. Stuart Hogarth at the University of Cambridge, and is a collaboration between researchers at Sussex, Cambridge, University of Toronto, and King’s College London.

Examining the relative roles of industry and the public sector in the discovery, development and adoption of new biological markers of disease (biomarkers), the project will look at the corporatisation of diagnostics research and development, its driving factors and effects.

Despite the extensive body of research into pharmaceutical innovation, and the role of drug firms as ‘corporate engines of medicalisation’, there has been comparatively little investigation into understanding the changing dynamics of diagnostic innovation.  

A decade after the Human Genome Project, major public and private investments continue to fuel expectations of a genomic revolution in biomedicine. Hopes for a new “age of diagnostics” are accompanied by concerns about scientific standards and how best to use public policy to steer innovation in the diagnostics sector.

With a specific focus on screening and the early detection of cancer, the project will map industry dynamics, technological trajectories and regulatory developments in Europe and the USA from 1996 to the present day. The recent boom in private R&D investment for cancer screening sits in stark contrast to the story of screening innovation in the 20th century, which was driven largely by public funding and academic research. However, the benefits of screening are increasingly contested, with concerns about the medical, economic and psycho-social impact of over-diagnosis and over-treatment.

The project aims to address the scarcity of research in this area, providing vital empirical evidence to inform policy discussions. Through this contribution, it also hopes to establish a platform for a broader body of research, and impact the debate on responsible research and innovation in the sector.

Methodology

Combining quantitative and qualitative methods, the project’s innovative dimensions include a new conceptual model of socio-technical transition in the diagnostics sector, and the first integrative analysis linking scientometric data on the interactions between public and private actors in the diagnostic research domain with comparative transnational analysis of regulatory decision-making.

Through a novel integration of conceptual insights from the literature on biomedicalisation and scholarship on socio-technical regime change, this project aims to advance both fields of research by applying a new multi-scale, multi-level model of socio-technical transition. The project will provide unprecedented insight into the factors shaping the development of a new generation of molecular diagnostic tests, and examine how these technologies are reconfiguring disease categories and redrawing the boundaries between health and sickness. It will establish a platform of theory and methods for a broader programme of work on diagnostic innovation.

Impact and Outreach

As a ground-breaking analysis of diagnostic innovation, the study will not only make innovative contributions to academic theory, but also feed into diverse policy interest in these issues. Through international workshops and an end-of-project conference, the team will engage with scholars and other stakeholders to disseminate data, explore methodological and conceptual approaches and plan future collaborations and engagement. The second of these workshops will bring together scholars interested in contributing to a collected volume/special issue to be edited by the project team. Serving not only to disseminate the findings of the project, these activities will build a platform for the development of a broader, long-term programme of research.

Alongside journal articles, the principal publications of the project will comprise a monograph, a collected volume (bringing together a range of scholars to examine the changing nature of the political economy of diagnostic innovation), and a policy-oriented collection of papers with contributions from stakeholders (to be published as a journal special issue). Major datasets from the project – such as the industry database and scientometrics data – will be made available online.

Partners

  • University of Cambridge
  • University of Sussex
  • University of Toronto
  • King’s College London

Funding Information

Running from April 2017 until September 2021, the project is funded by the European Research Council, under the Horizon 2020 Excellent Science programme.