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Screening for cancer in the post-genomic era: diagnostic innovation and biomedicalisation in comparative perspective

Periodic Reporting for period 2 - CANCERSCREEN (Screening for cancer in the post-genomic era: diagnostic innovation and biomedicalisation in comparative perspective)

Reporting period: 2018-10-01 to 2020-03-31

A decade after the Human Genome Project, major public and private investments continue to fuel expectations of a genomic revolution in biomedicine. The freight of expectations surrounding the new “age of diagnostics” is accompanied by much uncertainty about how public policy should steer diagnostic innovation, with much debate about inter alia the harms of creating diagnostic monopolies through gene patenting, and the risks of under- or over-regulation. However, due to the paucity of research on diagnostic innovation, policy deliberation is driven more by anecdote and expert opinion than empirical evidence.
With a specific focus on screening/early detection of cancer, this project maps industry dynamics, technological trajectories and regulatory developments in Europe and the USA from 1996 to the present day. 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.
The main publications of the project will comprise a monograph authored by the PI , a series of articles authored by the PI and the team, a special issue on the regulation of diagnostics in Social Science and Medicine bringing together a range of multidisciplinary scholars and a policy-oriented collection of papers with contributions from stakeholders published as a special issue of a journal such as Lancet Oncology. Major datasets from the project, such as the industry database and scientometrics data will be made available online. We are building collaborations with other scholars and engaging with stakeholders by disseminating by presenting papers (and organising panels) at major international conferences and by holding international workshops.
The project combines qualitative and quantitative research methods
Fieldwork – interviews conducted
- UK : 34 interviews
- France : 35 interviews
- EU/other: 12 interviews
Datasets produced
- Firm database – includes basic information on firms such as size, location and year of founding; financial data including funding rounds and turnover; and information on products marketed and in development and business models. The database currently includes @ 550 firms. A secondary dataset derived from this focuses on firms in the cancer screening / early detection sector and comprises 75 active firms and 122 tests. From this we have selected 30 firms/technologies for which we are gathering more in-depth data.
- We have produced multiple bibliometric datasets, that allow us to explore the changing nature of cancer research, and more specifically research on cancer screening / early detection.
30 firm/technology datasets – for each of the 30 firms/technologies we have compiled general information about the firm’s history, including financial data, such as investment rounds and
- Bibliometric dataset comprising scientific papers
- Intellectual property dataset comprising patents
- Regulatory dataset comprising regulatory decisions
Two key goals for our project were to help develop a broader programme of research on the political economy of diagnostic innovation through collaborations with other scholars and to inform public policy through engagement with policymakers. In 2018 we organised three international meetings in collaboration with Professor Fiona Miller, University of Toronto and Professor Steve Sturdy, University of Edinburgh.
Regulating Diagnostics workshop, January 5, 2018, Cambridge.
This event brought together scholars from Europe, North America and Brazil. The workshop allowed for sharing of data and discussion of theoretical/methodological approaches among social scientists working on the regulation of diagnostics.
Celebrating 50 years of Wilson and Jungner at 50 - workshop. 18-19 June 2018, London.
Our project focuses on a specific type of diagnostic application: screening / early detection of cancer. We are investigating how screening is governed, as part of our broader interest in the dynamic of regulatory expansion in the diagnostics sector.This workshop brought together policymakers from Asia Pacific, Europe and N America to share the experience and understanding of those currently engaged in the work of screening governance.
Regulation of Laboratory-Developed Tests – policy workshop 20 June 2018, London.
This workshop brought together current and former regulatory officials from Australia, the USA, UK and Ireland to discuss the regulation of laboratory-developed tests.
International early detection summer school, July 2018 Cambridge. This educational event was organised by the CRUK Cambridge Centre Early Detection Programme. The aim was to give scientists involved in the development of new technologies for screening/early detection of cancer, greater insight into the practical challenges of diagnostic test development.The PI helped to organise the programme, in particular the sessions on regulation and on bioethics.
The future of In-Vitro Diagnostics – a Regulatory Perspective. 15 February 2018, University of Cambridge. This research seminar was aimed at people in academia and industry involved in the development of new diagnostic tests. It included talks by the PI, Dr Alberto Gutierrez (former FDA director) and Dr Robyn Meurant of the World Health Organisation.
We have participated in workshops and conferences in Australia, Italy, Netherlands, Poland and the UK. Highlights includ the PI being an invited speaker at a WHO Conference on Screening in February 2020.
Our forthcoming special issue of Social Science & Medicine, the leading journal in our field, is early evidence of the academic impact of the project. It will be the first collection of social science papers focused on the regulation of diagnostic tests. Publications in the British Medical Journal and the Canadian Medical Association Journal (both co-authored with the former FDA director Alberto Gutierrez, indicate our potential for policy impact in the biomedical sector (as does our workshop with screening governance bodies).
Our database of the molecular diagnostics industry is unique, in particular our coverage of firms in Asia Pacific goes beyond existing commercial datasets.
Our research on the subset of 30 firms/technologies will provide new insights into the process of diagnostic innovation. This strand of the research is the first to link scientometric data on the interactions between public and private actors in the diagnostic research domain with comparative transnational analysis of regulatory decision-making. It will generate at least three papers exploring different dimensions of our model of soci-technical transition, in particular the corporatisation of R&D, regulatory expansion and pharmaceuticalisation.
phase two methods
phase one methods