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BARRIOS, WERUTSKY, AND MARTINEZ-MESA
The Global Conduct of Cancer Clinical Trials: Challenges
and Opportunities
Carlos H. Barrios, MD, Gustavo Werutsky, MD, and Jeovany Martinez-Mesa, MD, PhD
OVERVIEW
The nature of clinical research has changed substantially over the last 2 decades, evolving from being centered almost exclusively in
developed countries to a more global scenario that is increasingly involving less developed regions of the world. Pharmaceutical
companies and some academic cooperative groups have been conducting challenging, large pivotal registration studies with multinational
participation. The much more needed globalization of academic research demands particular attention and represents a
worthwhile subject for a more profound discussion. The requirement of large sample sizes and the potential for fast recruitment leading
to a speedy completion of clinical studies are probably the most important factors that have fueled globalization of studies. Reduced
operational costs and the ability to expedite the regulatory approval of drugs in various countries or regions are also important drivers.
Globalization of research should be seen as having a much wider effect in the societies involved, in particular, when we consider public
health, economic, social, and ethical implications. Most importantly, the process of expanding the network of clinical research sites also
fosters the integration and the development of closer relationships among investigators at a global level. We consider this an essential
element that should remain a prominent element in the discussion. In this article, we address the underlying reasons for globalization
and we highlight some of the scientific and ethical concerns arising as a consequence. Finally, some strategies to address and mitigate
the challenges of conducting multinational clinical research are proposed.
Globalization can be defıned as the integration of economies,
industries, markets, cultures, and policy-making
processes around the world. 1 Even though the concept is not
new, the current wave of globalization has been heavily
driven and influenced by fantastic and unprecedented advances
in the information technology that will likely have a
long lasting effect in the process. Even though globalization is
frequently approached with a focus in economy, the concept
has been increasingly broadened to include a diverse range of
areas such as culture, media and technology, socioculture,
and the political arena, among others. Proponents of globalization
argue that the ultimate result of this international
interaction should be economic development and improvement
of the standards of living.
Until not so long ago, drug development and cancer clinical
research were conducted almost exclusively in wealthy
developed regions of the world. However, over the last 2 or 3
decades, clinical trials have been progressively incorporated
in a challenging globalization process. As such, the conduct
of trials in a global scale represents a major aspect to be taken
into account when analyzing the future development of the
area. The globalization of clinical trials, as well as multinational
and multi-institutional research collaboration, represents
a scenario that requires permanent and concentrated
efforts by all involved if we are to achieve the fundamental
objective of generating the appropriate answers to the health
problems we face around the world.
Large pharmaceutical companies have been conducting
large pivotal registration studies increasingly with multinational
participation, and much has been discussed on the globalization
of clinical research addressing the subject from the
pharmaceutical industry perspective. However, the much
more needed globalization of academic research is at least as
challenging, demands particular attention, and represents a
worthwhile subject for a more profound discussion as well.
The requirement of large sample sizes and the potential for
fast recruitment leading to a speedy completion of clinical
studies are probably the most important factors that have fueled
globalization of studies, particularly of large registration
phase III trials. Other factors may include the reduced operational
costs and the ability to expedite the regulatory approval
of drugs in various countries or regions. However,
globalization of research should be seen as having a much
wider effect in the societies involved, in particular when we
consider the public health, economic, social, and ethical
implications.
The process of expanding the network of clinical research
sites also fosters the integration and the development of
From the Latin American Cooperative Oncology Group, PUCRS School of Medicine, Porto Alegre, Brazil.
Disclosures of potential conflicts of interest are found at the end of this article.
Corresponding author: Carlos H. Barrios, MD, Department of Medicine, PUCRS School of Medicine, Padre Chagas 66, 203, Porto Alegre RS, 90 570 080, Brazil; email: chbe@via-rs.net.
© 2015 by American Society of Clinical Oncology.
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