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Summary

The ASCO/NCI meeting on Overcoming Clinical Barriers to International Collaboration in Rare Cancer Clinical Trials meeting was held on December 10, 2010 in Bethesda, Maryland, following a meeting the previous day on Clinical Trials in Small Populations held at the ASCO Headquarters in Alexandria, Virginia. The NCI Cancer Bulletin published an overview of the meeting, and a more formal meeting report was prepared by the NCI. A research paper based on the meeting is now in preparation and will be submitted to a peer-reviewed journal. The meeting was sponsored by the NIH Office of Rare Disease Research, the NCI Cancer Therapy Evaluation Program, and the American Society for Clinical Oncology.

This meeting brought together international stakeholders including representatives of the NIH and the NCI-sponsored Clinical Trials Cooperative Group Program, to consider when international trials might be appropriate for studying rare cancers, develop a systematic approach to prioritize such trials, and to work on practical issues that would enable such collaborations to be conducted in a speedy and cost-efficient manner. In addition to U.S.Government (NIH, Food and Drug Administration, Office for Human Research Protections) and cooperative group representatives, other attendees included investigators from Canada, France, Japan, Korea, Singapore, the UK, the European Organisation for Research and Treatment of Cancer (EORTC), representatives from patient advocacy organizations, and industry.

This meeting's agenda built upon prior meetings that have examined more general aspects of international collaboration in clinical trials research and on design-oriented discussions of performing trials in rare populations. This meeting focused on those instances where it would not be practical to perform a phase II or III trial in North America alone. To help make the meeting more concrete, after general presentations, break-out sessions focused on five specific research areas identified previously in international meetings: rare pediatric cancers, adult brain cancers, sarcoma, cholangiocarcinoma, and rare gynecological malignancies. 

Presentations

 Except as noted, most of these presentations are in Microsoft powerpoint format. Please do not re-use these slides without the permission of the author.

Meeting Output

In addition to the summary documents mentioned above, several action items resulted from this meeting:

  • In the year following the meeting, the U.S. National Cancer Institute (NCI), European Organisation for Research and Treatment of Cancer (EORTC), and UK continued to meet by teleconference on a regular basis to develop a rare tumors initiative.  Each organization went to their specific disease-oriented groups, queried their interest and capabilities, and prioritized five "first tier" diseases for the initiative to focus on. Diseases that would be difficult or impossible to study outside of this framework(e.g., diseases that could not be studied with accrual from only one country and diseases that otherwise lacked international infrastructure), were intentionally selected. These included: 1) penile cancer; 2) gynecological sarcoma; 3) fibrolamellar hepatocellular carcinoma; 4) rare head and neck tumors (anaplastic thyroid cancer and salivary cancers); and 5) small bowel cancers. The group identified individuals to chair disease-specific meetings at the 2011 American Society of Clinical Oncology (ASCO) conference in Chicago, with the goal of bringing together world leaders in these diseases. The US, EORTC, and UK will work together to prioritize and fund clinical trials and organize investigator infrastructure in these diseases. Although not under this framework, there will also be a meeting on biliary cancer, which was a focus during an earlier rare cancer meeting. If this effort goes well, plans exist to replicate the process at future international meetings like ASCO or the European Society for Medical Oncology (the European equivalent of ASCO).
  • The international collaborative working group is developing tools to facilitate joint trials. A web portal for international investigators has been developed, is currently in beta testing, and will be rolled out at ASCO 2011. The portal is designed to provide answers to common questions about how to work with NCI from the perspective of a foreign partner.
  • At the Rare Cancers meeting, a break out discussion on operational issues between EORTC and the US cooperative groups was held. The group plans to host a larger follow-up meeting during ASCO 2011, which will involve operations center personnel from the majority of US cooperative groups, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), the EORTC, UK, and French Clinical Trial Networks. The results of that meting will be compiled on this wiki, and the wiki will be extended to capture practical solutions that have arisen in successful collaborations between the groups.
  • Since the rare cancer meeting, French cancer centers have successfully competed for phase II trials, including a sarcoma trial.