• RESEARCH APPROACH
    To paraphrase Bruno Latour (1987), we want to study “biomarkers in action”. That is, we want to improve our understanding of biomarkers by engaging with a set of biomarkers that have already been “downstreamed” and that are already deployed in clinical diagnostics and therapeutics, therefore making them promising empirical “answering machines” for our overall research question, how biomarker candidates are transformed into useful devices in clinical medicine. We will study them empirically and in context. We focus on the field of cancer diagnostics and therapeutics, as this field constitutes one in which biomarkers are in a comparatively advanced state (Nass and Moses 2007), giving us good reasons to believe that our findings will be based on solid empirical evidences. Moreover, the field provides empirical examples for all types of biomarkers that are applied in clinical practices (Ludwig and Weinstein 2005; Spinney 2006), allowing us to study biomarkers in their broad variety of forms.
    • QUESTIONS
   
1 Identifying the Dynamics of the Biomarker Field
      In our study we combine a political science approach in the argumentative tradition (Gottweis 1998; Sørensen and Torfing 2007) with a S&TS perspective (Law 1987; Oudshoorn 2003; Timmermans and Berg 2003). We argue that governance in the scientific-technological field depends on the enrolment of a broad variety of heterogeneous elements that range from scientific and technical, to social, political, and economic ones. From this perspective, the success of a biomarker, might, for instance, be as much shaped by the support of a particular patient group as by its scientific quality. On the other hand, a biomarker might fail to be applied if general practitioners are not successfully enrolled or if a particular platform is not robust enough to travel. What sort of elements are involved in the making of biomarkers is to be studied empirically. Hence, the first major research question of our project is: Which elements are enrolled in the development, validation, and application of biomarkers?
   
2 The governance of biomarkers
      Our goal is not only to identify key elements in biomarker governance but also to show how these elements interact and how these are made to interact. Thus, our second theoretical argument holds that the successful trajectory of a biomarker from bench to bedside involves the complex interaction of a number of scientific, technological, social, economic, and political elements that are amenable to be managed and coordinated, and hence amenable to be governed.
      By “governance” we refer to all those tools, measures, and devices that are mobilized by a multiplicity of actors and authorities, with which the interaction of the elements involved in the development, validation, and application of biomarkers are coordinated and managed. Such instruments might relate to the rules of biomarker validation of a formal regulatory body, or to specific programs set up to unite private and public institutions to standardize the way in which data on biomarkers are collected and to facilitate the sharing of these data among the members of this network. In this perspective, biomarker governance also refers to the development of a business model or “awareness raising” activities calling upon seemingly healthy people to have their blood checked or fostering the public understanding of biomarkers. The second major research question in our project is: How, by whom and adhering to which devices and tools is the interaction of the elements involved in the development, evaluation, and application of biomarkers steered, coordinated, and governed?
   

3 The governance through biomarkers
      In addition to focusing on (1) which factors are involved in the development, evaluation, and application of biomarkers, and (2) how these factors are coordinated and governed, we will also pay attention to (3) how biomarkers interact with society. Adopting a co-production perspective, we argue that the development and application of biomarkers shapes socio-political norms as much as the making of biomarkers is shaped by them (Jasanoff 2004a; Jasanoff 2004b). From this perspective, then, biomarkers are not only an object of governance; they are also entities through which governance materializes, and hence instruments of governance (Gottweis and Petersen 2008).
   
Governance through biomarkers relates as much to a transformation of how diagnoses are done in clinical practices, and hence to a shift in the power structure within a university hospital, as it does to a change in the understanding of health and disease by people who have been found to be at risk in a biomarker test or to the shaping of new identities of new groups of patients. There will be many examples of ways in which the development and application of biomarkers spill over to society, shape social norms and truth, and help to order societies. The third major research question in the proposed research project is: How do biomarkers interact with societies, and in doing so, help to shape society?
     
     

  
  Summary of research questions:

  Research question 1: What are the key elements involved in the development, evaluation,
  and application of a (successful) biomarker?

  Research question 2: What are the emerging governance patterns in the field of biomarker development?

  Research question 3: How do biomarkers interact with society and what does this imply for
  biomarker governance?
     
   
• METHODS
    In trying to answer our three research questions, we study biomarkers in context, by “following them around” retrospectively from their clinical application back to their early development in different sites. Each case study reconstructs the biography of the biomarker under scrutiny, tracing the movements of its early design and development to its various sites of applications. These sites, that might range from laboratory and clinical units to regulating bodies and pharmaceutical venues, are our primary units of analysis. We will provide “thick descriptions” (Geertz 1973) of the heterogeneous entities and practices that these sites involve, as well as of the tools and strategies, rules and norms that are deployed to coordinate and shape these entities.
      We deploy a mixture of methods that include analyzing written texts and policy documents, developing a set of qualitative expert interviews with policy makers, scientists, physicians, patients, and other important actors at these sites (Weiss 1994), and exploring ethnographic observations (Clarke 2005). Obviously, it is not be possible to provide such “thick descriptions” for all sites in which biomarkers are developed and used. We therefore select those sites that promise to be the most interesting in regard to finding answers to our three research questions.
Updated 24.04.2010