institutional studies are fraught with the complexities of data stratification, and frequently promising single institutional studies are not confirmed when reassessed in a multi-institutional ~e t t i n g . ~
As head and neck surgeons, we must assert that, until a well-established framework for study is constructed, further expenditures in multi-institutional trials are inappropriate.
It is suggested herein that the National Cancer Institute recognize this fundamental problem and adopt a new direction in funding for head and neck cancer studies. It is essential that a consensus be reached on proper stratification data (tumor description, treatment, and multiple other variables to be included in prospective studies), if we have any hope of gleaning which group of patients will benefit from treatment. This will require a concentrated effort, bringing together the relevant treatment disciplines with biostatisticians to establish a mutually agreeable platform which could be applied to multiinstitutional as well as single institutional trials.
It is suggested therefore that: (1) The NCI should fund an intensive study of methodology. (2) This multidisciplinary process should include biostatisticians, epidemiologists, experts in cancer biology, and the traditional clinical disciplines. (3) We specifically restructure tumor description, surgical procedure reporting, pathologic reporting, laboratory studies, and outcome measures. Otherwise, we are bound to whirl round about in perpetual agitation, ending where we began.