A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.

This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from both pharmacological and organizational science, which addresses human factors and transparency, to enhance organizational learning and continuous improvement. As happens with investigations in other sectors of society, such as the chemical and aviation sector, this systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. 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.

Characterizing benthic substrates of Santa Monica Bay with seafloor photography and multibeam sonar imagery.

Seafloor photography from three cruises is combined with multibeam sonar imagery to characterize benthic substrates and associated fauna of Santa Monica Bay, California. The multibeam EM1000 imagery was collected in 1996. Two sampling cruises (in 1998 and 1999) provided photographs at 142 sites throughout the Bay; a final cruise (in 2000) collected still photographs and continuous video along nine transects on the mainland shelf from Pt. Dume to the Palos Verdes peninsula. Muddy substrates (typically low backscatter) were the predominant habitat throughout the Santa Monica Bay, from the 20 m isobath to the adjacent Santa Monica basin floor (780 m). Bioturbation was pervasive as evidenced by abundant open burrows, mounds, and faunal tracks and trails. Sandy substrates (typically intermediate to high backscatter) were restricted to the innermost mainland shelf and a narrow outer shelf band north of Santa Monica Canyon. Cobble and gravel substrates (high backscatter) were restricted to the innermost shelf south of El Segundo and limited parts of the shelf edge. Rocky substrates (high backscatter) with interspersed patches of sand and gravel occurred on the high-relief marginal plateau and along parts of the shelf break offshore of Malibu.