Site Accreditation & Standards Initiative (SASI)
Accreditation addresses the need for a cohesive, effective approach to promoting and sustaining excellence of clinical research sites, while ensuring that such excellence is recognized and rewarded.
The costs of conducting clinical trials include inefficiencies inherent in the current process, a process that suffers from a lack of uniform standards, interconnectivity and interoperability.
Uniform global standards for clinical research sites and independent third-party accreditation do not exist at this time. Standards allow the objective identification and assessment sites, which in turn supports sustainability.
Accreditation promotes professionalism and enhances sustainability while reducing cost and time required to effectively evaluate promising products, supports regulatory oversight and compliance, and also promotes responsible ethical conduct to make new, safe medicines available to patients more quickly with improved outcomes.
ACRES Site Accreditation and Standards Initiative (SASI) Timeline
The first phase of SASI surveyed the current landscape and gathered perspectives from a wide-range of stakeholders. Building on the first phase, which focused on identifying existing requirements and standards, the second phase includes a series of global stakeholder consultations, began in North America (San Diego) in June of 2014. Additional consultations will follow in Europe, Asia, Latin America, Africa and the Middle East.
Concurrently, working groups will begin drafting standards, each focused on one several domains: personnel, facilities, management, information technology, quality, integrity, and recruitment.
Building on this work, an implementation approach characterized by multiple accreditation levels related to the risk-level and complexity of trials will allow the broadest range of sites to participate while improving performance and compliance, including small sites conducting only a few trials a year. This also makes the effort much more inclusive, and addresses concerns about barriers to entry for new sites if the standards too onerous.
The approach also incorporates competency-based training and certifying clinical research professionals created by a number of globally oriented organizations and dramatically facilitates implementation of new risk-based monitoring paradigms.
Elements of Effective Accreditation
Collaboration among diverse stakeholders insure that a full-range of multiple perspectives is incorporated in SASI with the most critical common issues being identified and addressed. Accreditation must serve the needs of all stakeholders and appropriately reward those who seek and become accredited.
ACRES engagement with multiple stakeholders through SASI has implications that go beyond achieving consensus on site-standards and performance metrics. It demonstrates the value and effectiveness of systems solutions in complex environments and presents a contrast to the silo’ed approaches that create unintended problems and repeatedly fail to reduce costs and improve quality. Further, such engagement, in this case on site-standards development, demonstrates the value of broad-based collaboration in the larger realm of clinical research.
A Global Model for Effective Site Accreditation
SASI also seeks to define metrics for assessing site capabilities and performance, allowing sites to validate their compliance with regulations, ability to enroll patients, and effectively conduct trials.
Standardization and metrics increase efficiencies and reduce the costs of running clinical trials. High-performing sites are a valuable resource, and their consistent identification is challenging. Without an accepted, consistent set of standards and accompanying metrics, it is impossible to understand, measure, and compare performance across sites. To achieve consistency of data quality and trial execution, one must evaluate well-defined performance data.Sponsors and patients also benefit from objective quality and safety measures to make decisions about which sites to choose for participation in trials.
Given the differences in perspectives and approach, as well as in regulatory requirements in different regions, achieving consensus regarding appropriate and fair standards challenging. SASI has already catalogued regulatory requirements around the world and identified a set of core common requirements to be used as a starting point without disagreement or adding onerous compliance requirements for existing sites.
SASI: A Comprehensive Process
The ACRES Global Network will include thousands of affiliated sites of excellence, sites committed to adoption and application of standards and technologies that will facilitate their workflow optimize performance and enhance their sustainability and professionalism. This network of accredited sites, with professional clinical research teams and facilities all over the world, will be a valuable resource within a global system that recognizes and rewards their excellence and commitment.
A Global Clinical Research System