Sara ValenciaSPS Department
Science, Technology & Innovation Studies
Sara Valencia was trained as a biologist in Colombia with a strong background in the standardisation of pre-clinical studies and tissue culture. She is a PhD candidate in Science and Technology Studies at the University of Edinburgh, and her PhD research aims to understand the knowledge flow across organisations working on multi-sites clinical trials to evaluate vaccines in Colombia, Brazil and Mexico. Right now, she is a consultant for the Open Society Foundation for the Access to Medicines and Innovation program in the field of biomedical innovation in Colombia, Brazil and Argentina, at the present she is developing a report on research and development models to create new biomedical products in these three countries.
- 2006-2010. B.Sc. in Biology. CES University, Medellín, Colombia.
Awards and Funding
- Global Justice Academy and Global Development Academy. Discussion of the political and social situation in Colombia after the peace agreement. October 2016.
- Funding provided by organiser committee to participate at the FAPESP’s São Paulo Summer School of Advanced Sciences of Biotechnology, Biosocialities and the Governance of Life Sciences. Campinas, Brazil, August 11-15, 2014.
- Colombian National Scholarship. Sponsor: COLCIENCIAS. Program: Science and Technology Studies. 2012.
- Colfuturo Scholarship: Program: MSc in Management of Bioeconomy, Innovation and Governance. University of Edinburgh September 2012. Funding not used.
- Funding Enlaza Mundos: Sponsor: Medellin council, Colombia. Program: MSc in Management of Bioeconomy, Innovation and Governance. University of Edinburgh September 2012. Funding not used.
- Best graduated biology student and academic excellence. Biology program. CES University and EIA. Medellin, Colombia. December 2010.
- Academic Honorable Mention for personal achievements and academic merit at Biology Program. CES University and EIA, Biology Program. Medellin, Colombia. Years: 2010- 2009- 2008-2007.
- Scholarship first-semester undergrad student for obtained a high score in the admission exam at National University of Colombia (UNal). Program Biology Engineer. January 2005.
- Social recognition Mention to civics and values. Colombia's Military Forces, National Army 4th Brigade– Medellin Colombia, Year: 2000.
Innovation Clinical Trials Knowledge managment Biomedicine and politics Latin America
- 2014, 2015: Co-organiser of the PhD students day workshop.
- 2012- 2013, 2015. PhD student co-representative for Science, Technology and Innovation Studies.
- Co-founder of the Colombian association of scholars in UK (Abecol). 2015
- Co-Organizer of the First Research Symposium Colombia- United Kingdom. September 23 and 24, London, UK.
This thesis offers insights from knowledge management theory to understand the flow of knowledge across the multiple actors involved in the execution of a clinical trial in Latin America. In the last 12 years, the participation of Latin America in the business of clinical trials has significantly increased, becoming a highly demanded region to implement sponsored clinical research, overtaking regions like Africa, India, Southeast Asia, and Middle Eastern countries. Also, over this period, sponsors have increased the outsourcing of in-house activities such as trial monitoring, pharmacovigilance and regulatory services to Contracted Research Organisations (CROs), shifting the ‘two organisations’ and bi-directional relationship between the sponsor and the research sites. This change in the clinical trials landscape has also taken place in Latin America, where in addition to the CRO, the figure of Site Management Organisations (SMOs) has emerged to manage multiple research sites over the course of the trial. Therefore, the internationalisation of clinical research, plus the outsourcing of strategic activities, have transformed the implementation of clinical trials in the region.
On the other hand, the results of a clinical trial depend strongly on the analytical skills and cognitive capabilities employed by people working on the project. These characteristics make the clinical trial a Knowledge Intensive Project (KIP), where the main project outcomes depend to a large extent on the use of knowledge by the workers, and the transfer of knowledge data and information across the multiple organisations working in the clinical trial. Because knowledge is the primary production factor in a clinical trial, and in the context of Latin America, to my knowledge, there is reduced research about the production of clinical evidence and the role of each one of the actors over the execution. In this research, I propose and evaluate a three-step model to study the flow of knowledge, data and information across multiple organisations being part of the clinical trial and the use of these to produce the knowledge products by the sponsor and the research sites.
This model has its roots in the literature of knowledge ‘models, work and processes’, the concept of interdependence and the literature of knowledge transfer and acquisition in the outsourced project. The model consists of three steps to address, at the inter-organisational level, the transfer and acquisition of knowledge, data and information and the interdependency on results; and at the intra-organisation level, the use of knowledge and storage. The presented model was evaluated and complemented based on the evidence collected through a multi-case study of three multi-organisational clinical trials to evaluate three new vaccine candidates in Colombia, Brazil and Mexico.
The findings of this research indicated that the model was robust to study the flow of knowledge, data and information between the sponsor and the research sites, from the design of the protocol until the production of the clinical data. The results also indicate that the presence of intermediaries decreases the transfer of knowledge and information between the parts, and induces the selectivity of the research sites toward one of the sources of knowledge. The evidence shows that the acquisition of knowledge by physicians demands a knowledge-destruction capability to actively employ the acquired knowledge in the trial. The empirical findings of knowledge and data acquisition by the research sites and the sponsor contributed to developing the concept of permeability, contributing to the literature of knowledge acquisition in outsourced projects. This research addresses, for the first time, the implementation of vaccine clinical trials in Latin America countries and the contribution of the local researcher to the project, especially with their knowledge about the communities intervened. But it also highlighted some of the aspects that affect the implementation of clinical trials, such as the labour conditions in academia which induce turnover, and the lack of harmonisation among clinical trial regulation in the region. In conclusion, the model proposed allowed me to address simply the complexities that take place in the production of knowledge products in multi-organisational clinical trials in Latin America countries.