Simultaneous global pharmaceutical development, registration and outcomes research (OR) strategies are now commonplace. However, incorporating Japan into global OR plans is a challenge. OBJECTIVE: This paper addresses the concerns of global OR researchers by presenting a systematic approach to incorporating Japan into global research protocols and strategies. METHODS: Informal interviews with managers involved in global R&D or OR planning and a literature review of pharmacoeconomic studies was conducted. Based on knowledge gained from several years of actual experience conducting outcomes research in Japan, these information sources were synthesized into a recommended approach for incorporating Japan into global OR plans. RESULTS: 39 published studies were found in the Japanese and English literature from 1980-2001, however, no mention of global research protocols was found. Based on interviews three activities were recommended to effectively incorporate Japan into global OR plans/protocols: 1) a Japan OR expert should first review draft global OR plans/protocols and prospectively identify critical success factors in Japan, then 2) Japan OR expert should draft Japan plans/protocols, and 3) establish a strong feedback loop from global OR to the Japan OR expert to incorporate Japan input in global plans/protocols. Critical success factors in Japan include: 1) academic expert assistance 2) feasibility assessment 3) institutional commitment 4) strategic fit with Japan. Building draft Japan plans/protocols requires a preliminary assessment of Japan's medical environment: 1) clinical practice 2) epidemiology 3) political, sociological, ethnic and health care financing issues 4) regulatory issues. Establishing a strong communication link between Japan and global OR will ensure that the Japan plans are integrated into the global OR plans/protocols. CONCLUSION: Global outcomes research plans/protocols must incorporate Japan. Working with a Japan OR expert is highly recommended so that global research plans adequately reflect an awareness of critical success factors and the local medical environment in Japan.