International Trials – NCIC, EORTC, IBCSG and others

As improvements in cancer treatment have led to increased survival, the need for expanded collaboration on treatment trials has correspondingly increased. First, new active treatments which prolong survival in turn often require larger sample sizes to detect potential benefit from experimental regimens or to determine the similar efficacy of a less toxic regimen. Second, developments in molecular biology have allowed the use of molecular markers to define patient cohorts based on tumor biology, “splitting” rather than “lumping” histologically-defined cancer populations into smaller genomically-defined diseases. As a result, we must cast a wider net to enroll the necessary number of patients with the appropriate molecular classification. Third, the success of effective screening and earlier diagnosis has decreased the incidence of advanced-stage disease for certain cancers. The accrual of sufficient patients with advanced-stage disease for phase III clinical trials may require collaboration across geographic barriers. Fourth, targeted therapy may offer effective treatment for relatively rare tumor types or rare subtypes of common cancers. Our ability to conduct definitive trials in rare tumors is likely to depend on recruiting patients from around the world. Fifth, the integration of the plethora of new cancer treatment agents into existing treatment regimens will require successful phase III comparisons to standard treatment. In many diseases, the rapid design and conduct of these randomized treatment trials necessitates international collaboration in order to evaluate new treatment regimens rationally and swiftly, so that results are relevant to current clinical practice. Finally, the completion of larger trials across multiple countries will assure the broad applicability of research finding worldwide.

To facilitate international collaboration, we have undertaken several initiatives. First, we have worked with our colleagues from the NCI-sponsored Clinical Trials Cooperative Groups, the European Organization for Research and Treatment of Cancer, the British National Cancer Research Network, and Cancer Research United Kingdom to identify barriers to international collaboration and how best to overcome them. Second, we have undertaken to work with colleagues from the NCI-sponsored Clinical Trials Cooperative Groups to share best practices and develop a long-range plan for integrating sites outside of the US and Canada into the Clinical Trials Cooperative Groups. Finally, we continue our efforts to provide technical assistance to countries in the developed world as they work to strengthen their public clinical trials networks.