ATYPICAL RESPONDERS LANDSCAPE REVIEW ∙ OCTOBER, 2017 29 SUGGESTED ACTION ITEMS 5 Standardize how data are captured and de-identified regardless of source to allow accessible mining by authorized researchers across platforms and systems. Leveraging a secure platform for access to data regarding exceptional responders, rapid progressors, and exceptional survivors will help detect survival patterns and formulate and improve testable hypotheses. 1 Develop unified categories of exceptional responders, rapid progressors, and exceptional survivors, including qualitative and quantitative criteria (Table 4, p. 35). 3 6 Establish an MBC patient registry. As discussed in this paper, several disparate studies are underway regarding atypical responses, with more likely to follow. To help facilitate research in a consolidated and coordinated manner, the MBC Alliance envisages creating a registry that would solicit information from MBC patients worldwide about their disease. The entered data will be de-identified and stored on a central platform that will be made available to sanctioned researchers for analysis about atypical response and other issues of importance to the MBC community. 4 Investigate why all three subtypes of atypical responders show extraordinary outcomes. Exceptional survivors may or may not be enrolled in a trial, and stakeholders will need to work with experts to develop methodologies to study these patients and the factors contributing to their survival. 5 4 3 Encourage funding agencies to accelerate exploration of the underlying factors governing atypical responses including CIM, co-morbidities, and the entire patient, without limiting the study to tumor markers or genetics. These factors should also be investigated in normally responding patients. 1 2 Enhance clinical trial design to: a. study exceptional responders and rapid progressors relative to specific treatment outcomes; b. capture data about exceptional survivors who enroll in the study; c. obtain data about multiple aspects of a response to therapy; d. encourage collection of a common set of data elements, including health-related quality of life measures, across clinical trials; e. use standardized questionnaires to gather more information about CIM modalities practiced, supplements consumed, co-morbidities and drugs taken for them, etc., look for correlations, and perform retrospective and prospective analyses to test hypotheses about potentially important factors. 2 FOR THE MBCA, OTHER ADVOCACY ORGANIZATIONS, AND RESEARCHERS