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BARRIOS, WERUTSKY, AND MARTINEZ-MESA
erated a number of projects that will facilitate global integration
and development of local expertise. 8 Although these are
initiatives signaling a positive direction, they still fall short of
what is really needed and a wider and more consistent international
integration of academic research remains a challenge
that should be addressed with much more emphasis in
the future.
ASPECTS OF GLOBALIZATION OF CANCER CLINICAL
TRIALS
Why Is Globalization Unavoidable?
In our opinion, a number of factors do contribute for this
globalization trend to continue and increase in the foreseeable
future. In Fig. 1, we attempt to didactically address the
large number of issues that are part of this complex process.
First, among many other factors, we need to consider the
large number of patients required for confırmatory trials in
the drug development process. Recruitment issues are undoubtedly
one of the most important elements to take into
consideration explaining the need for multinational trials.
This has an important effect in shortening timelines in the
drug development process. Recent statistics indicate that less
than 5% of U.S patients actually participate in clinical trials. 9
In the United Kingdom, from 2001 through 2011 the National
Cancer Research Network was able to boost recruitment
in cancer trials with a substantial increase in
participation from 3.7% to 17%. 10 Costly delays in recruitment
are seen in 86% of trials, and in 94% of the studies the
delay is more than 1 month. 11 Low accrual rates have a negative
effect in the development of new therapies, as trials take
longer to achieve endpoints with consequent delays in the
interpretation of the results and sometimes leading to early
closure of studies with substantial waste of precious resources.
Since accrual in developing countries can be 5 to 10
times faster than in the United States or Europe, globalization
is no longer an option, but a dear necessity for sponsors. 12
As an added and very important characteristic, patients
enrolled in developing countries are more frequently
treatment-naive and have less, or many times, no competing
trials as alternatives. 13 Although this certainly represents a
central and positive factor for certain studies, regional treatment
availability has a number of other possible consequences
that need particular attention and are discussed later
in this article.
Another important driving aspect is the fact that the cost of
running clinical trials in developing countries is lower than in
developed countries. The cost of conducting clinical research
in Brazil, Russia, India or China (BRIC countries) can be a
fraction of what it would be in the United States or most
Western European nations. 14 With the increased need for
larger trials, lower operational costs are a crucial consideration.
With the substantial savings obtained conducting
trials in developing countries, increasingly, more phase II
and phase III trials are being conducted in India and South
America. 11
Finally, in this era of personalized or precision medicine
the need for small specifıc populations with a defıned targetable
marker will be a vital element to consider in the drug
development process. The issue of variability in the frequency
of a specifıc tumor subtypes in different populations
or regions of the world is another important consideration.
FIGURE 1. Globalization of Cancer Clinical Trials
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