Accepted Paper:

Knowledge management in multi-site clinical trials in Latin America.  

Authors:

Sara Valencia (University of Edinburgh)
Alessandro Rosiello (University of Edinburgh)

Paper short abstract:

Production of knowledge in clinical trials in Latin America is reshaped by the alliance with public health organizations, the meta-coordination of research activities between actors working in the trial, and their ability to learn, introduce, and transfer information through the network

Paper long abstract:

STS and post-colonialism studies approaches to clinical trials in Latin America countries have focused on drugs, and clinical trial governance systems by large pharmaceutical companies. However, the actual research activity conducted at clinical sites has been overlooked, and less attention has been paid to how knowledge is managed inter and intra organizationally by researchers.

In his work I report findings from the research I have been conducting on the outsourcing of the clinical evaluation of three dengue vaccine candidates in Brasil, Colombia, and Mexico. 55 Semi-structured interviews were conducted with research site members, sponsors, clinical monitors, ethics committee representatives, and regulatory agencies with the aim of study how research sites and sponsors produce scientific evidence and data, and coordinate their work during the trial.

This paper goes beyond the conventional pharmaceutical governance discourse by examining the differences between public and private funded projects, and contrasting highly experienced sites vs new sites, arguing that the production of scientific evidence in clinical trials, is the result of how knowledge is managed by and between a variety of agents in a complex and fragmented network. This means, that knowledge, information, and data are continuously transmitted, transformed and learned throughout the project; and the production of valid data depends on the sites' expertise, ability to learn, and knowledge about of volunteers and public health organizations.

This paper contributes to the debates on track STS for pharmaceuticals and public health policy by addressing issues on the complexity of knowledge production in multi site clinical trials

Panel T017
STS for pharmaceuticals and public health policy