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Investigation of how competing cultures within IAVI play out in a developing country clinical trial setting

Brusoni, S   Cacciatori, E   Hanlin, R   Orsenigo, L

April 2012

Innogen working paper no. 103

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Introduction

We started our research from the premise that the International AIDS Vaccine Initiative (IAVI) – as an organisation – creates an environment and sets itself the task of gap filling and knowledge integration, including conduct of clinical trials. This is due to its mandate at set up as a Product Development Partnership (PDP) to remove the disconnect between basic and applied research and clinical development stages. In this way PDPs are seen to overcome an apparent market failure whereby traditional pharmaceutical companies did not get involved in drug and vaccine development for diseases affecting low income countries where profit margins are low. At the same time, the emphasis on clinical trials initially followed IAVI’s emphasis at start up of also focusing on advocacy and being seen as aiding the international development scene. These two areas of activity (promoting science and conducting advocacy) play out within the organisation being impacted by existence of competing cultures[1] within the organisation and its partners.

We can identify a number of competing cultures and resulting storylines within IAVI and its partners. Studying how these cultures play out within a micro arena, such as the clinical trial research setting, provides a way of getting to grips with the contestation that is created. Highlights the main negotiations and differences played out due to meeting of different cultures. It also, as this paper highlights and fitting with certain arguments within institutional sociology, highlights the power and politics flows within innovation activities and the linkages between the micro and macro social. At same time taking this approach also investigates and adds further to literature on how clinical research functions.

The theoretical starting point for this paper is beyond knowledge integration. There is a significant amount of literature on institutionalism and its impact on organisational function within firms and networks. Furthermore there is a body of literature on routines and practice and its benefit or problems created to the successful working of firms and partnerships. However, in both cases, this has not been considered through the lens of clinical trials yet. Another literature (medical anthropology and science studies) has however highlighted the role of routines and practices on clinical research and the impact it has on work functioning. This paper attempts, via micro level case study analysis, to bring these together and say something new about clinical research and clinical trials in developing countries. In so doing it questions the legitimacy of IAVI’s gap filling role at this level.

The paper discusses these issues by first introducing the cultures that predominate within IAVI’s New York office and the potential ‘cultural nightmare’ that is created and needs managing. To simplify the discussion we split these cultures crudely and broadly into two sets of alternative ‘cultures’ based at one end of a spectrum around an emphasis on the business of vaccine science and at the other the needs and role of IAVI as an international development organisation. The paper then discusses the way a number of storylines dominate ways of acting within IAVI’s clinical trial research partners in Kenya play out mirroring the issues at the heart of the competing cultures dominating within the IAVI New York Office. The paper concludes by questioning the degree to which this mirroring highlights a dominance of and introduction of IAVI’s cultures into the Kenyan setting and the implications that the findings have on IAVI’s gap filling activities.

[1] By culture we refer to the work of Geertz and Schultz. Geertz defines culture as “a historically transmitted pattern of meaning embodied in symbols, a system of inherited conceptions expressed in symbolic form by means of which men [sic] communicate, perpetuate and develop their knowledge about and attitudes towards life” (Geertz, 1973, p. 89). Schultz discusses studying culture within organizations in this way. He writes, “Opposed to the study of both formal and informal organizational behavior, a cultural way of studying organizations is to study the meaning of organizational behavior – or, more specifically, the meanings and beliefs which members of organizations assign to organizational behavior and how these assigned meanings influence the ways in which they behave themselves” (Schultz, 1995, p. 55).