Product Safety Culture Initiative (PSCI)

ACRES is promoting 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 group of subject matter experts developed the PSCI Project Plan in May 2013 based on a 2012 outline. From 11 potential projects, the Project Steering Committee selected 3 for current action, with a goal of 2Q 2014 for up to two being further developed into proposals for partnerships and pilot projects.

The Basis of Systems Thinking


First-in-Human Trials

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.

To our knowledge, there has never been an attempt to map out a system to demonstrate the innovation pathways and processes and how safety-related risks are controlled. A standardized risk management system, built on sound safety engineering systems principles would ensure that Phase 1 trials will be successfully and more safely conducted and completed.

Here, success means confidence that everything possible has been done to demonstrate whether or not there is potential for further development into an effective therapy while optimizing safety for research participants.

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.

Further discussions about this project are ongoing with safety engineers including at an international safety engineering conference in September 2014.

Clinical Research Site

Clinical Research Site


A Unifying Safety Database: “Predictive Pharmacovigilance”

PCSI has also turned to improving routine 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.

Discussions are underway with two organizations with access to ‘supercomputers’, a US federally-funded R&D corporation (FFRDC) and an international IT company based in Japan. The project is expected to start in Q3/Q4 2014. 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.

Public Outreach and Education:

The PSCI Project Steering Committee is also exploring a public outreach-focused project for journalists reporting on biomedical R&D and how best to assist their work to be more effective in explaining safety-related issues to the public, potentially in collaboration with the European Patients’ Academy on Therapeutic Innovation (EUPATI), an Institute for training public advocates and other ‘translators’ of science to the public founded by the Innovative Medicine’s Initiative.