On December 10, the National Cancer Institute (NCI) and the American Society of Clinical Oncology convened a meeting to explore ways to collaborate across borders on clinical trials for rare cancers. The meeting brought together nearly 100 representatives from 75 institutions, including the National Institute of Health’s Office for Rare Disease Research, the US Department of Health and Human Services, and the Food and Drug Administration. According to Dr. Jack Welch of NCI’s Clinical Investigations Branch, “International trials for rare cancers offer many advantages over separate trials done in different countries or regions. By bringing patients together, international trials can accrue faster, and they offer lower collective administrative costs, shared infrastructure, centralized resources, and use of existing networks.”
However, international clinical trials face a number of unique challenges including discrepancies in regulatory requirements, intellectual property concerns, restrictive contractual agreements, and the coordination of operations between organizations. These challenges may be overcome through careful planning, frequent communication, and cooperative collaboration.
Earlier this year, CFCF’s Executive Director, Lauren Erb, spoke on behalf of neuroendocrine tumor patients at the FDA public hearing on “Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases.” Lauren argued that novel approaches are necessary to develop effective treatment options for neuroendocrine tumors. International clinical trials represent an opportunity to benefit the worldwide rare disease community by most efficiently advancing science and facilitating treatment development. Click here to read Lauren’s speech to the FDA. Click here to view her slide presentation.
Read the full NCI Cancer Bulletin, “Statistical Strength in Numbers: International Clinical Trials for Rare Cancers.”