Mar 28, 2011
Dr. Čufer, of the Council for Emerging National Security Affairs, at a 2008 cancer research workshop in Ljubljana, Slovenia.
April 2011 Issue
AC: How would you describe the state of clinical research in Central and Eastern Europe (CEE)?
Dr. Čufer: Clinical research in CEE has a long-standing tradition. In 1988, the Central and Eastern European Oncology Group was established. Within this group, 12 member states with more than 30 research centers cooperated on clinical research. The efforts of this group had a major impact on the discovery and development of certain drugs, such as anthracyclines and platinum derivates. Additionally, the countries of CEE tend to work collaboratively with other research groups, including the European Organisation for Research and Treatment of Cancer. Pharmaceutical-sponsored research conducted by various organizations is also increasing, but there is a lack of investigator-driven clinical research in this area.
AC: What advances have you seen in the past 10 years? In what ways do you believe the political changes of the 1990s affected research in the region?
Dr. Čufer: The majority of CEE states opened their borders in the beginning of the 1990s and joined the European Union (EU), which resulted in an increased flow of knowledge and expertise, an ease in the migration of scientists, and the simplification of the grant application process for young researchers. These advances helped CEE researchers and research centers improve collaboration with the rest of Europe and abroad.
A 2004 EU directive, however—which was implemented with the aim of improving patient protection and stimulating clinical research in Europe—resulted in a tremendous increase in bureaucracy. Consequently, the number of trials conducted was reduced, as well as the number of patients enrolled in these trials. The worst blow was received by international-, academic-, and investigator-driven trials. The European Commission is now trying to revise this directive based on input from researchers, patient groups, and others.
AC: What are some of the unique challenges faced by clinical cancer researchers in the region?
Dr. Čufer: One of the most troubling challenges is the ever-increasing amount of bureaucracy required to conduct clinical trials. EU’s clinical trial directive more than doubled the cost (a 120% increase) of initiating a clinical trial in Europe.
Another pressing issue is that cancer research in CEE countries, which mostly belong to the middle-income group, receives significantly less funding compared to high-income European countries. The CEE countries’ shortages come from a lack of charitable funds dedicated to cancer research. Both the shortage of skilled personnel and money has resulted in the decline of academic-, investigator- and/or collaborative-group–driven clinical research.
The third major challenge is how to motivate young doctors to invest their time and effort into learning how to design, plan, and conduct their own investigator-driven research trials.
AC: What future do you see for clinical cancer research in the region?
Dr. Čufer: In this region, multidisciplinary cancer care has had a long-standing tradition. The field has always been well respected and nourished. Most of these countries have nationwide cancer registries and comprehensive cancer centers with multidisciplinary facilities and well-trained staff. Building on these attributes by adding new facilities—especially for phase I and II trials—as well as encouraging and training young oncologists will further improve cancer research in CEE countries.
In addition, the future of cancer research in the region could be very bright if a shift from non-interventional phase III or phase IV trials into more demanding phase I and phase II clinical trials occurs and if the health authorities recognize the need to stimulate research instead of halting it with unnecessary bureaucracy.
AC: What will you focus on during your 2011-2012 term as Chair of the International Affairs Committee?
Dr. Čufer: As a long-time researcher, I will work to stimulate and improve clinical research worldwide. I firmly believe that putting more patients in clinical trials is one of the better ways of improving cancer care throughout the world. The next important issue is to establish clinical practice guidelines that could be implemented all over the world. These should not only be evidence-based guidelines, but should include setting priorities based on clinically meaningful benefits. With cancer treatment becoming more and more expensive, it is our job and mandate
to define priorities and settings for rational use of limited resources. Last but not least, I will dedicate my activities to setting up and improving the quality of prevention and palliative care programs in low- and middle-income countries.
AC: How is cancer care being recognized by the global community?
Dr. Čufer: Non-communicable diseases represented mainly by cancer and heart diseases are becoming the leading cause of mortality all over the world. Each year, 7.6 million people die from cancer. Two-thirds of these deaths are in countries with low or middle income, with this ratio expected to further increase. This issue will be one of the topics addressed by the United Nations General Assembly in September 2011.
ASCO, among other organizations, is preparing a program to deal with these issues, based on what the General Assembly is predicted to adopt as a resolution. Since the resolution on prevention and control of cancer will mainly be oriented to middle- and low-income countries, it is my belief that the International Affairs Committee—with its insight into the problems that such countries face—needs to play an active role in preparing documents that may lead to this resolution.
Dr. Čufer is a Professor of Oncology at Medical Faculty, University of Ljubljana, Slovenia, and Senior Consultant at the University Clinic Golnik, Slovenia. She will take office as Chair of ASCO’s International Affairs Committee at the 2011 ASCO Annual Meeting.