The globalization of oncology.

The world of breast cancer research has always, to some extent, been a global enterprise but never so much as it is today. Wherever one looks, there is evidence that breast cancer research is undergoing the same globalization that characterizes so much of industry and culture. This change manifests itself through organizational, pharmaceutical, and regulatory means. Organizational: Individual research groups (eg, Eastern Cooperative Oncology Group, Southwest Oncology Group, European Organization for Research and Treatment of Cancer) were once self-contained units, performing their own metastatic and adjuvant trials without reference to other groups. Today, driven by the increasing size of trials, there are consortia of groups such as the North American Breast Cancer Intergroup, the Breast Cancer International Research Group, and the Breast International Group that regularly perform multithousand patient trials across borders. We are now beginning to see consortia of consortia; for instance, the collaboration of the North American Intergroup and the International Breast Cancer Study Group perform important trials that would either go undone or take too long to perform without collaboration. Studies themselves are now presented and analyzed on an international basis. Several years ago, the American Society of Clinical Oncology became, for all practical purposes, the International Society of Oncology, with significant international membership, international board members, and presenters and discussants from every continent. The breast cancer adjuvant trials are regularly analyzed, although rarely published, by what is colloquially known as the Oxford Overview. Pharmaceutical: A significant portion of breast cancer research is conducted under the auspices of international conglomerates, so-called "Big Pharma." In the past, these companies had distinct national characters. As a result of progressive mergers across borders and the formation of research institutes at sites distant from corporate headquarters, these organizations now think in international terms in the design and conduct of research, particularly clinical research. Regulatory: Recent years have seen the frequent approval by the US Food and Drug Administration of agents based on studies performed largely or entirely outside the United States. The need for such studies is based partly on economics, partly on the needs of Big Pharma for multicontinentregulatory approvals, and partly on unavailability of patients with frontline metastatic breast cancer for trials in the United States. This trend will certainly continue. One wonders whether, in time, we will see some globalization of regulation driven by the needs of pharmaceutical companies, equivalent to the World Trade Organization. The globalization of oncology has obvious benefits. In science and medicine, knowledge is knowledge, wherever it is generated. The ability to enter patients on large, international trials undoubtedly hastens the approval of agents beneficial to patients. However, globalization also poses real challenges. Standards of care do differ, and patterns of care can affect study outcomes and the interpretation of studies. Organizationally, the convergence of research efforts across international borders has a long way to go. Intellectual property and data ownership issues have barely even begun to be considered in international studies. Research funding for non–company-related studies is tenuous, and development times are long. There is a real danger of producing "lowest common denominator" studies, or studies fatally compromised by arguments arising from differing cultural, financial, and pattern of care imperatives. Nevertheless, the globalization of breast cancer research appears to be here to stay. The size of the studies needed to answer the important questions mandates cooperation.