Pharmaceutical companies are increasingly conducting drug development research outside of the United States, Western Europe, and Japan. Attracted to the perceived lower costs, easier patient recruitment, and market potential, drug developers are now conducting more phase III clinical trials in areas such as China, India, Latin America, and Central and Eastern Europe.
But what of the doctors and nurses in these regions who now find themselves approached by pharmaceutical companies? Are they ready to conduct trials for the commercial drug industry? Do they know all they need to know about regulations, informed consent, and ethical issues, not to mention how to get paid properly for their work? And are they learning it from sources that aren’t the drug companies themselves?
ASCO’s Advanced Cancer Courses Program Responds to Need
To help address questions like these, ASCO has launched the International Clinical Trials Workshop as part of its Advanced Cancer Courses program, which was begun in 2005. Each Advanced Cancer Courses implementation represents a partnership between ASCO and an international oncology society to provide high-level training to oncologists where there’s a perceived need. A mix of local faculty and faculty sent from ASCO present each course.
The International Clinical Trials Workshop has turned out to be among the program’s most popular offerings to date. Piloted in 2009 in Buenos Aires, the 2-day interactive workshop has taken place three times in 2011, in Egypt, Romania, and Uruguay. The courses had more requests for attendance than they were able to accommodate.
Other Advanced Cancer Courses programs are Cancer Care in the Older Population; Cancer Prevention; and EPEC-O: The Education in Palliative and End-of-life Care for Oncology Curriculum.
Not Enough Experienced Principal Investigators
According to Lucia Delgado, MD, President-Elect of the Federation of Latin American Cancer Societies, training is needed now because places such as India, Eastern Europe, China, and Latin America are seeing a huge influx of clinical trials, putting a strain on the limited number of experienced clinical investigators there.
“In Latin America, there are countries that are well prepared to conduct biomedical research. However we face some challenges, in particular regarding clinical trials, including making sure we have an appropriate number of well trained and experienced researchers,” said Dr. Delgado, local course chair and coordinator for the Uruguay workshop held in Punta del Este.
Seventy-six people attended the workshop that Dr. Delgado led, from principal investigators to research nurses, data managers, and clinical trial coordinators. The workshop delved into best practices in clinical trial implementation, trial design, patient recruitment, the tenets of good clinical practice, patient safety, and nuanced ethical and regulatory issues. It also answered frequently asked questions about publishing, said Dr. Delgado, who is a former ASCO International Affairs Committee member and Head of the Clinical Oncology Department at the University of Uruguay.
Evaluation data collected at two of this year’s workshops showed that 77% of attendees intended to change their research practices based on what they learned at the workshop, and 61% made new relationships with other professionals involved in research, or strengthened the ones they already had.
Luis Ubillos, MD, was in that number. The young Uruguayan oncologist had worked on basic and translational research on molecular markers and immunotherapy as a medical student, but wanted to get more guidance before taking the plunge to become a principal investigator. He said that hearing lectures from very experienced local researchers and later getting to network with them was invaluable. Also of particular interest, he said, was the workshop’s focus on regulatory requirements in Latin American countries.
Focus: Not Just Big Pharma
“Almost all the studies [coming to Latin America] are financed by the pharmaceutical industry, and in all cases there is minimal participation of local investigators in clinical trial conception, design, analysis, and reporting,” Dr. Delgado said. But she stressed that conducting clinical trials proposed by the pharmaceutical industry isn’t the workshops’ only focus. Each workshop also includes a presentation on how to stimulate more research from the local community, for the local community. To that end, she said, local or regional trials are necessary for developing therapeutic strategies that meet local and regional needs. “To achieve this, the implementation of academic courses like the International Clinical Trials Workshop is a significant contribution,” she added.
As for 2012, ASCO is teaming up with the Federation of Latin American Cancer Societies and the Brazilian Society of Clinical Oncology for a workshop in São Paulo in March, and collaborating with the Indian Cooperative Oncology Network to host a meeting in Mumbai in the summer. In addition, ASCO is exploring partnerships for conducting future workshops in China and Southeast Asia.
“I certainly recommend the workshop to young oncologists,” said Dr. Ubillos. “It is an excellent tool for beginning your career as a clinical investigator.” ■
© 2011. American Society of Clinical Oncology. All rights reserved.