ASCO International Clinical Trials Workshop (ICTW) Working Group Chair
|Dr. Tanja Cufer presents at the International Clinical Trials |
Workshop in Kathmandu, Nepal
In October 2014, Kathmandu, Nepal was the first country in South Central Asia to host one of the most prominent international activities organized by ASCO, the International Clinical Trials Workshop (ICTW). The ICTWs are based on an idea set forward by Dr. Eduardo Cazap, past Chair of the ASCO International Affairs Committee (IAC), with the purpose of promoting and supporting clinical cancer research in emerging-economy countries. The main goal of ICTWs, organized jointly with the local scientific societies, is to deliver education in globally accepted standards in conducting and promoting clinical research tailored to local needs, as well as to stimulate research on the international level. The first ICTW was organized in 2009 in Buenos Aires and was later followed by four meetings in South America, two in Central and Eastern Europe, one in Russia, and another in Egypt. This year marked the first of what is surely to become a long line of successful workshops held in the South Central Asia region.
The initiative for the 2014 ICTW in Nepal was set out by the South Asian Association for Regional Cooperation (SAARC) Federation of Oncology (SFO) in cooperation with colleagues from the Indian Cooperative Oncology Network (ICON), ASCO, and the U.S. National Cancer Institute (NCI). SAARC countries (Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka) are home to roughly one-quarter of the world’s population and 10% of newly diagnosed cancers per year worldwide. As in the rest of the world, the cancer incidence is rising in these countries, with head and neck cancer in men and cervix and breast cancers in women being the most common malignancies. Unfortunately, their cancer control resources in terms of available staff, equipment, and finances are severely limited, with substantial differences observed between the SAARC countries. The same goes for cancer research work and publications. Where India surely stands out with its strong and impactful presence, it is a sharp contrast to smaller countries where oncology is far less developed. Commercial, pharma-driven research is increasing in these countries, while academic research, adapted to the specific needs of the region, is lagging behind. From these needs sprung the idea to organize the first South Central Asia ICTW in Nepal in October 2014, which the ASCO ICTW Working Group embraced with open arms.
The two-day ICTW in Kathmandu provided 65 attendees (mostly early-career oncologists and residents from Nepal, India, Bhutan, and Bangladesh) with basic principles on how to plan, conduct, and publish their own clinical research. A majority of the participants had no previous formal training in the methodology of clinical research and spend most of their time seeing patients in a routine clinical practice. Excellent and globally renowned international and local faculty members from ASCO, NCI, ICON, and SAARC SFO were present at the ICTW. Two lecturers (who were also the Program Directors responsible for the preparation and content of ICTW Nepal) should be pointed out for their above-and-beyond contributions: Dr. Rajendra Baral from SAARC SFO and Dr. Purvish M. Parikh from ICON and ASCO. Through excellent cooperation with ASCO and NCI they managed to provide the participants with a superb program and carry out the workshop at the highest possible level.
Despite substantial diversity in basic knowledge as well as previous experience in clinical research among the participants, we were able to conduct the very ambitious program and thoroughly discuss the whole range of clinical research. The two-day workshops presented the basic principles of ethics, methodology (good clinical practice, or GCP), planning, and publication of clinical research. One of the main advantages of the Nepal workshop was that our lecturers were focused on very practical, basic guidelines on how to carry out highly ethical research in their environment while ensuring high international standards. The participants were provided with short and concise instructions on how to conduct clinical research in an environment where the researchers commonly play the roles of the researcher, data manager, and monitor. Incredibly active discussions touched on some important local issues, such as long and hard-to-understand patient information leaflets in a region where over half of the patients are illiterate, the access to new drugs after completion of the clinical trial, etc. The participants pointed out the barriers they are facing when trying to publish their own research findings in international literature. In a setting that demands perfection both in style and grammar, it is increasingly difficult for these researchers, working without any external assistance, to publish their work in international journals, even if the findings are exemplary and noteworthy.
As we have already noted in several other ICTW meetings, the Nepal workshop once again confirmed to us that one of the best received and most appreciated sections is the portion where participants work together with the lecturers in smaller groups and prepare a draft of a clinical research protocol. The participants were asked to bring with them a research proposal. A proposal was selected by each working group and transformed during two workshop sessions into a draft of a clinical trial protocol. Despite different levels of knowledge and experience in the field of clinical research, the participants (with the aid of a statistician and faculty members) prepared intriguing drafts of clinical research protocols tailored to local needs. In contrast to the Vail or Flims Workshops, we did not prepare fully finalized clinical research protocols, which could be implemented immediately; however, we still prepared well-designed first drafts of the protocols which could lead to full protocols with some additional work and collaboration between the participants, their local mentors, and ICTW faculty.
Given the fact that the opening ceremony of ICTW was attended by both the Minister for Health and a high representative in charge of research in Nepal, we were reassured that they are on board with our endeavors to strengthen clinical research in the region and able to wrap up ICTW Nepal knowing that our goal and purpose were achieved.
Tanja Cufer, MD, PhD, is a Professor of Oncology at Medical Faculty, University of Ljubljana, Slovenia and Senior Consultant at the University Clinic Golnik, Slovenia.