Scientific Publications by FDA Staff

Integr Environ Assess Manag 2017 Jul;13(4):640-51

Assessing the reliability of ecotoxicological studies: an overview of current needs and approaches.

Moermond C, Beasley A, Breton R, Junghans M, Laskowski R, Solomon K, Zahner H

In general, reliable studies are well designed, performed, and enough details on study design and performance are reported to assess the study. For hazard and risk assessment in various legal frameworks, many different types of ecotoxicity studies need to be evaluated for reliability. These studies vary in study design, methodology, quality, and in the level of detail reported (e.g., reviews, peer-reviewed research papers, or industry-sponsored studies documented under Good Laboratory Practice (GLP) guidelines). Regulators have the responsibility to make sound and verifiable decisions and should evaluate each study for reliability in accordance with scientific principles regardless of whether they were conducted in accordance with GLP and/or standardized methods. Thus, to evaluate studies for reliability, a systematic and transparent approach is needed. In this paper, eight different methods for reliability assessment were compared using a number of attributes: categorical versus numerical scoring methods, use of exclusion and critical criteria, weighting of criteria, whether methods are tested with case studies, domain of applicability, bias towards GLP studies, incorporation of standard guidelines in the evaluation method, number of criteria used, type of criteria considered, and availability of guidance material. Finally, some considerations are given on how to choose a suitable method for assessing reliability of ecotoxicity studies.