Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
2020. Age, smoke exposure and infectious causes of cancer (HPV, Hepatitis B,
and H. pylori) will continue to drive the burden of cancer in the region. Cancer
mortality rates in Latin America are approximately twice those of the United
States (1). 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
(2). Up to the 1980s, North American and European cooperative groups
mostly sponsored by the National Cancer Institute (NCI) conducted most of
the pivotal practice changing trials. At that time, a progressive shift in the
funding of research toward pharmaceutical companies was seen. In parallel,
an increasing participation of research sites from countries outside North
America and Western Europe was identifıed and has since transformed the
development of new medications to what is now an increasingly globalized
process (2). The number of registered clinical trials has increased in all
geographic regions during this time period, with the average annual growth
greatest in the Asian (30%) and Latin American/ Caribbean (12%) regions (3).
Early trials seem to be conducted more frequently in North America (62%),
whereas confırmatory trials are more frequent in Eastern Europe, Latin
America, and Asia (4). Data from ClinicalTrials.gov shows that over 70% of the
registered cancer phase I trials are conducted in the United States, whereas
less than 1% are conducted in Latin America. In larger registered phase III
studies, 40% are conducted in the United States, 43% in Western Europe,
and 17% in Latin America (5). 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 allow researchers to
expect the development of locally coordinated research addressing pertinent
regional health questions benefıting the local community. As quality is a
fundamental principle in the conduct of clinical research, we need to address
monitoring, auditing, and inspections as a basic element in the process of
globalization. In recent years, a number of independent research groups have
been created in Latin America:
The Chilean Cooperative Group for Oncological Research (Grupo Oncológico
Cooperative Chileno de Investigación, or GOCCHI) is a nonprofit corporation
registered in Chile since 1998. GOCCHI is conducting academic clinical trials in
oncology based on the highest scientific, methodologic, and ethical standards
(http://www.gocchi.org).
The Peruvian Oncology Clinical Studies Group (Grupo de Estudios Clínicos
Oncológicos Peruano, or GECOPERU) was founded in March 2005 as a
nonprofit academic and research organization. It has a central operating
office and partnerships with several international groups (CIBOMA, IBCSG,
BIG, and others) (http://www.gecoperu.pe).
Founded in 2007, the Argentine Group for Clinical Research in Oncology
(Grupo Argentino de Investigación Clínica en Oncología, or GAICO [is
composed of 15 cooperating groups and includes various health professionals
from public and private institutions (www.gaico.org.ar).
The Latin American Cooperative Oncology Group (LACOG) was founded in
2008 by medical oncologists from several Latin American countries that
has developed a network of investigators in oncology for epidemiologic and
clinical studies in cancer. LACOG has 47 members in 39 sites from 10 countries
in the region. Currently, the group has several ongoing studies. The Brazilian
Group of Thoracic Oncology (GBOT) is currently hosted at LACOG and is
involved in some research initiatives (www.lacog.org.br) (www.gbot.med.br).
CLICaP (Latin American Consortium for Lung Cancer Research) This
consortium was created in 2010 to develop collaborative studies on the
biology, diagnosis and treatment of lung cancer. CLICaP has published over 20
studies involving participants from Mexico, Costa Rica, Panama, Venezuela,
Colombia, Ecuador, Peru, Chile, Argentina and Uruguay. Some of this work has
established genomic differences between populations for mutations in EGFR,
KRAS and ALK ROS1 following analysis of over 8500 samples (7).
There are several challenges of research in South America including costs
(6), regulatory issues and difficulty in recruitment but there also several
advantages of performing trials in developing countries such as availability
of patients, lower costs and faster accrual. 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
alternative (8) As more trials are conducted in resource-limited settings,
good clinical practices and ethical assurances must be secured. Human
participation in clinical research is essential to advance medicine and public
health, and expanding clinical trials mandates constant oversight to ensure
research quality and protection of study subjects. Some decades ago, the
development of global clinical research could have been considered a dream;
it is now a pressing need that should be considered unavoidable in the
future (2).References: 1 Goss, P; Lee, BL; Badovinac-Crnjevic, T et al. Planning
Cancer Control in Latin America and the Caribbean. Lancet Oncol 2013; 14:
391–436 2 Barrios, C; Werutsky, G and Martinez-Mesa, J. The Global Conduct
of Cancer Clinical Trials: Challenges and Opportunities. ASCO Educational
Book, e132- e139, 2015 3 Drain PK, Robine M, Holmes KK, et al. Trail watch:
global migration of clinical trials. Nat Rev Drug Discov. 2014;13:166-167 4
Thiers FA, Sinskey AJ, Ernst R. Trends in the globalization of clinical trials.
Nature Reviews Drug Discovery. 2008;7:13-14. 5 www.clinicaltrials.gov 6 Kaitin
KI. The Landscape for pharmaceutical innovation: drivers of cost- effective
clinical research. Pharm Outsourcing. 2010;2010: 3605. 7 Rolfo C, Caglevic
C, Bretel B et al. Cancer clinical research in Latin America: current situation
and opportunities. Expert opinion from the first ESMO workshop on clinical
trials, Lima, 2015. ESMO Open 2016;1 8 Smith WT. FDA requires foreign clinical
studies be in accordance with good clinical practices to better protect human
subjects. ABA Health eSource. 2008; 5:1-3.
Keywords: Cooperative Groups, Latin America, research
SC23: THE IMPORTANCE OF CO-OPERATIVE GROUPS
TUESDAY, DECEMBER 6, 2016 - 16:00-17:30
SC23.03 HOW COULD HIGH-VOLUME CENTERS IN DEVELOPING
COUNTRIES ACCESS COOPERATIVE GROUP TRIALS?
Ugur Yılmaz
Pulmonary Medicine, Izmir, Dr. Suat Seren Chest Disease and Surgery Training and
Research Hospital, Izmir/Turkey
Lung cancer has the second highest absolute incidence globally as well as
in developing countries and ranks fourth in developed countries. It is the
most common cause of cancer death by absolute cases globally as well as in
developing and developed regions. The economic burden of lung cancer care
is highest relative to other cancers in the European Union. Research is at the
core of achieving improved outcomes from cancer, be it in defining countryspecific
epidemiology of the disease, understanding the pathogenesis of
disease, identifying new targets for therapeutic agents, or directing policy to
achieve affordable and equitable outcomes. Cancer researchs are one of the
most globally active domains of science, with more than $14 billion per annum.
A critical part of the health research portfolio is the testing of interventions
through randomized controlled trials. Trials can range from highly controlled
explanatory trials through to pragmatic trials of new health technologies
and models of service delivery. Recruitment problems also have practical
and financial impacts, as they can delay completion of research or reduce its
timely impact on patient health and wellbeing. Achieving appropriate levels
of patient and professional participation has been a significant obstacle to
evidence-based practice. Published data show that the minority of trials
recruit successfully, either in terms of reaching their planned sample size, or
delivering the planned sample in the expected recruitment window Despite
all the diffuculties, clinical trials have become increasingly globalized due to
the inclusion of more non-traditional locations, especially those in central and
eastern Europe, Latin America, and Asia. The increased globalization of clinical
research has arisen for several reasons, but primarily due to the need for
faster and more economically efficient studies. Moves towards standardizing
and harmonizing clinical research practices have facilitated the rise of
globalized clinical research. However, the expansion of multinational clinical
research peaked in 2009, which could reflect that the large-scale expansion
of multinational clinical research effort has reached its global capacity.
When the distribution of multinational clinical trials is examined after being
stratified according to the condition or disease, lung cancer is not among
the five most frequently studied conditions apart from Asia. The results of a
bibliometric analysis of global research on lung cancer between 2004-2013 in
the 24 leading countries in cancer research showed that despite a doubling
of the volume of lung cancer research worldwide between 2004 and 2013,
it still only accounts for a small proportion of the overall oncology research
publication output (5.6%). In fact, the relative commitment (RC) to lung
cancer research compared with that to total oncology research output has
fallen in most countries during this period, including in the 23 countries with
exception of the China. Turkey, Poland, Canada, Greece, and the United States,
despite having the highest country-specific burden of lung cancer, have all
seen a decrease in their RC to lung cancer research. Research from Norway,
Austria, Switzerland, Belgium, and Sweden had the highest proportion of
international contributors . By comparison, relative to their research output,
the East Asian countries (Taiwan, India, the Republic of Korea, and Japan)
and Turkey had the least amount of international collaboration. With regard
to multinational studies, only 1.2% of articles had collaborators from five or
more countries and 0.3% from 10 or more countries. The aim of co-operative
groups in oncology is to perform multi-center clinical trials for cancer
research. Research results are often conveyed to the worldwide medical
community through scientific publications. In order to complete the trials
within the period specified, it is obvious the need of the qualified and high-
S66 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017