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A systems approach to enhance clinical research and medicines development

Honorio Silva, Greg Koski, Matthew Whalen, Mary Tobin, Beat Widler, Al O. Pacino II, Brian Edwards

Abstract

The biopharmaceutical industry has traditionally been the key link between basic biomedical discovery and novel medicines. Today, the industry faces numerous challenges including the broad agreement that the current clinical trial system is inefficient and flawed. Most challenges are worsened by the inability of the stakeholders to work colla-boratively. Over the last decade, many cooperative efforts to transform clinical research have been launched, but a sys-temic solution has not been envisioned. A systems approach, including the application of systems engineering principles, has been used in other sectors and proposed for use in healthcare and medicines development. Clinical research, when looked at in systems terms, can be defined as an open system involving patients, investigators and associated staff, regulators, sponsors and stakeholders interconnected through a series of processes to bring effective and safe medicines into the market. ACRES is a global nonprofit organization with a mission of creating a multi-sector alliance of individuals and institutions collaborating on building a shared global system for clinical research excellence. A fundamental element of the ACRES system includes a global network of high-performing research sites interconnected through a shared information technology platform, with standardized policies and operational procedures and a robust, secure database to support performance, quality and safety. Five core initiatives address the larger mission and are currently ongoing. De-liverables will roll out over 2015–2018. Positive reception to the concept, vision and goals among critical stakeholders, and a steady influx of strategic allies willing to work collaboratively demonstrates the strong pull exerted by the vision of a global system. However, due to the undertakings’ scope and complexity, challenges remain. Recognition that effective shared collaboration is the best long-term option among stakeholders and the general public constitutes a powerful in-centive for ACRES contributors and strategic allies to keep working and make it happen.

Keywords

clinical research; systems approach; site accreditation; core competencies; shared information technology platform

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DOI: http://dx.doi.org/10.18063/jmds.v1i1.111
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