Product Safety Culture Initiative (PSCI)
ACRES promotes adoption of a safety culture across the entire medicines development enterprise to address problems such as on-going recalls of approved products; post-marketing Risk Evaluation and Mitigation (REMs) requirements; loss of public trust in the safety of biomedical products; and high costs of safety litigation and settlement; the need for an independent entity to investigate safety incidents and systemic safety concerns.
Members of the PSCI Steering Committee have previously published the principles of such a Safety Culture in peer-reviewed journals. Within clinical research there is a vast amount of ‘safety evidence’ from organizational science, which is not being systematically implemented resulting in poor error management, unsafe practices and risk aversion. The Product Safety Culture Initiative (PCSI) intends to explore application of safety engineering techniques to designing safe systems for clinical research.
A critical step in developing new innovative therapeutics is the move from preclinical laboratory and animal studies into testing in humans. This is the time when there is a substantial loss of potential novel products and significant risks to research volunteers.
One project under development is to better define the system for first-in-man research. A common roadmap for early development and evaluation of potential new medicines will lead to enhanced sharing of information and benchmarking of safety-focused systems. Such an approach will identify systems gaps resulting from a lack of controls or constraints, which should have been imposed on the system design and operations.
These approaches are supplemented by understanding the place of human factors in safety metrics, quality control and risk minimization as delineated in Human Factors and Organizational Science.
A Unifying Safety Database: “Predictive Pharmacovigilance”
PCSI has proposed enhancing pharmacovigilance (and safety oversight) for devices, biologics, and other medical products by creating a single database where all relevant safety datasets can be integrated.
This Unifying Safety Database project is a phased approach starting with principles developed by experts of the Project Steering Committee for open-access Clinical Research Safety Informatics and leveraging high-performance computer modeling and simulation capabilities through a multi-sector partnership, going beyond mere detection of safety signals to achieve what has been called “predictive pharmacovigilance—the ability to anticipate drug toxicity and safety issues before harm is done.
The incorporation of safety-focused standards and metrics in ACRES Site Accreditation Standards Initiative (SASI) is an example of the integration of ACRES matrix of Foundation Initiatives.
We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change. As we will discuss further on, approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design.
Independent Investigation Collaboration
ACRES and the International Society of Pharmacovigilance have jointly called for the application of systems thinking and human factors research into existing processes for investigation of harm in clinical research involving medical products.
“We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change… approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design.”