NcXHF

GLOBALIZATION OF CLINICAL TRIALS
To appropriately address some tumor subtypes, we will need
trials that will screen very large populations to identify specifıc
patients. Globalization not only addresses this challenging
point, but also allows for subgroup comparisons and
other inferences.
What Are Some of the Advantages of Globalization of
Clinical Trials?
Conducting clinical trials in developing countries may facilitate
local product approval, thereby generating local drug
prescription more quickly. 11 At the same time, it is very important
to consider that globalization of clinical trials not
only benefıts the sponsor, but also global health. Expansion
of clinical trials into developing countries brings new medical
care options to subjects who may not even have the current
standard of therapy available. In parallel, there are clear
benefıts to the local medical community that has earlier access
and exposure to new drugs and therapeutic advances.
Involvement of investigators from developing countries in
the planning phases of the trial is essential as they may provide
valuable contribution while being exposed to an experience
that will have long lasting effects in the future
development of regional studies. Other than addressing a
question that interests a pharmaceutical company, developing
a reliable research infrastructure and local expertise
allows us to expect the development of locally coordinated
research addressing pertinent regional health questions benefıting
the local community.
What Are Some of the Challenges of Globalization of
Clinical Trials?
The globalization of clinical trials raises logistical challenges
that need particular attention. In Table 1, we present a few
general suggestions to address some of the issues and help in
the conduct of global trials; only some of them are addressed
in the discussion. As a fırst consideration, we need to take
into account the wide cultural differences among regions
participating in international clinical trials. Although this
can be seen as a positive consequence that will certainly enrich
the process making results more widely applicable, cultural
characteristics remain a very particular aspect that
needs to be addressed from the inception of the trial. The
perception of what clinical research is varies substantially
across regions and populations, and may influence the willingness
of subjects to participate in a study. Interpretation of
placebo arms, local dietary habits, use of herbal medications
or alternative treatment methods, adherence to treatment
and other protocol procedures, and reporting of adverse
events all can be perceived differently in different regions of
the world. The patient-doctor relationship also varies across
cultures and may have an effect in different aspects of care
that can affect the results of a clinical trial.
One of the most central challenges of globalization relates
to the regulatory aspect of running trials across borders with
different legislations. Even though there are initiatives to harmonize
regulatory legislation across regions and countries, it
remains a very diffıcult objective to reach. Good clinical practice
(GCP) harmonization has gone a long way and has been
TABLE 1. Addressing Some of the Challenges of Globalization of Clinical Trials
Problem
Solution
Regulatory Standards
Harmonize regulatory standards, processes, and procedures for the pharmaceutical industry (e.g., ICH, ICH Global
Cooperation Group Members)
Share science-based goals and standards for product safety, quality, and efficacy
Leveraging Knowledge and Resources
Use finite resources strategically and more efficiently, sharing knowledge and information, leveraging inspection
resources (share inspection data, plan joint inspections, provide parallel advice to sponsors, organize regular
discussions that increase communication)
Advancing Regulatory Science
Actively engage global partners to harness scientific development, resources, and brainpower to support
science-based regulatory decision making and pursue the best possible public health solutions
Risk-Based Monitoring and Inspection
Use innovative strategies and tools to identify sites for clinical inspection (e.g., GCP risk-based site selection
tool for clinical inspection)
Build Quality During the Planning
Incorporate prevention strategies to avoid critical errors, and monitor for those errors
Stages of Clinical Trials
In the planning stages of the protocol, consider potential regional variations in standards of care and the
impact they may have in trial results
Central Laboratories and Bio-Banking
Decentralize laboratories developing regional expertise that will have significant “carry-over” benefits once the
trial is completed
Advance, harmonize, and simplify bio-bank regulatory issues
Invest in Research and Evidence-
Characterize the epidemiology of disease in specific regions
Based Cancer Care Relevant to
Create and strengthen national cancer registries
Each Region
Monitor local cancer outcomes and study the regional cost-effectiveness of specific interventions
Build a clinical trials infrastructure that is sustainable and will support local/regional innovative research and
educational opportunities
Promote translational research initiatives
Abbreviations: ICH, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; GCP, good clinical practices.
asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK
e135