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The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based non-profit operating in the public interest, has taken the first step in its plan to create a globe-spanning framework of regional and national affiliates with the opening of its first national affiliate, ACRES Japan, in Tokyo last week.
The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based non-profit operating in the public interest, has taken the first step in its plan to create a globe-spanning framework of regional and national affiliates with the opening of its first national affiliate, ACRES Japan, in Tokyo last week. Dr. Fumimaro Takaku, president of the Japanese Association of Medical Sciences, will provide leadership to ACRES Japan in his role as president of Board of Directors. ACRES Japan will provide a model for ACRES National Affiliates around the world.
Addressing the pervasive dysfunction and inefficiency in today’s fragmented clinical research enterprise—escalating costs, delays, waste, poor site-performance, ethical and legal lapses, public mistrust, decade-long lag-time from discovery to market—ACRES allies are working together to construct a comprehensive, integrated global clinical research system, including a network of high-performing professional sites using common standards, procedures and inter-operable information technologies acceptable world-wide, with a focus on safety, ethics, quality and efficiency.
To meet the needs of the modern clinical research enterprise, any such system must be global. Clinical trials are increasingly conducted internationally, but without standardization or interoperability among the many different stakeholders in the research enterprise.
Further, these diverse stakeholders – including sponsors and CROs, government ministries and regulators, service providers, professional organizations, ethics committees, patients, and research sites – must construct the global system for the benefit of all stakeholders. And demographic challenges, vastly different medical care systems as well as cultural values regarding safety, quality, and transparency must be accommodated.
Accordingly, ACRES utilizes both a stakeholder alliance and a global outreach approach. The organizational structure of ACRES reflects this essential outreach, working through regional coordinating centers and national affiliates to provide both a “home” for the necessary alliances, initiatives and collaborations as well as the focused, visionary leadership to make it happen.
ACRES Japan, ACRES first National Affiliate, was established by organizations within Japan to develop high-quality clinical research both within Japan and worldwide by promoting education and training of investigators and study team members, supporting site accreditation, and developing an IT platform for effective information sharing.
Dr. Fumimaro Takaku, president of ACRES Japan, set high goals for the new organization, noting that "Clinical research must be conducted with high transparency; education and training of physician investigators for clinical research must be rigorous; a code of conduct for physicians collaborating with pharmaceutical companies for clinical search must be assured--addressing these concerns will lead to highest quality and efficiency of clinical research in Japan. Through ACRES Japan, we are committed to finding effective solutions to these challenges.”
In addition to its distinguished Board of Directors, ACRES Japan Executive Officers are Kyoko Imamura, Ichiro Uchida, Kishio Ono, and Yasushi Suzuki. Planned activities range from advocating collaboration among like-minded organizations and individuals across Japan to participating in working groups of ACRES global initiatives and developing clinical research infrastructure in Japan. ACRES Japan will promote activities involved in education and training of investigators and study teams, site accreditation, and the development of an IT platform for global networks linked to hospital information systems.
ACRES Japan will also create mechanisms to facilitate communication and collaboration between ACRES and local academic institutions, regulatory agencies, health systems, professional associations and patient organizations and to identify opportunities to further leverage ACRES-related Initiatives in Japan.
ACRES President Greg Koski applauded his Japanese colleagues, saying, “This is a remarkable accomplishment by any measure. Organizations across the Japanese clinical research endeavor have shown extraordinary leadership, uniting to build a collaborative framework and expectation for excellence, one that will set very high standards and clear pathways for other nations seeking to achieve these goals. We look forward to our work together, not only with Japan, but with other countries worldwide.”
ACRES is a neutral, non-industry organization operating in the public interest. ACRES serves as a home and coordinator for multi-stakeholder collaboration, an incubator for innovation, an adapter of successful models and practices from other highly regulated and complex research-focused industries, an integrator for complex cross-cutting initiatives, a leader offering new ideas and directions and an implementer putting system solutions to work. For more information, please contact Dr. Mary Tobin at [email protected]