Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

Abstract

Background: There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates.Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards.Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations.Discussion: Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data.Conclusions: Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

Data Quality, Reliability, and Relevance Standards for Ecological Risk Assessment: Recommendations for Improvements to Pesticide Regulation in Compliance with the Endangered Species Act

“…We introduce questions to aid in establishing data reliability and relevance, and a data quality pyramid that illustrates how the base of data reliance is strengthened by components of reliability and quality. These pieces of the puzzle are combined in a potential weighting scheme (as suggested by McCarty et al (8)) that can form the basis for study selection in a given risk assessment. To illustrate various challenges that lack of relevancy and reliability bring, we introduce examples of influential data that are not relevant or reliable in a given risk assessment setting.…”

“…FIFRA studies conducted under Good Laboratory Practices (GLP) obviously fulfill the "relevancy" intent of DQOs because they exist as a suite of data intentionally developed to serve a specific risk assessment process. McCarty et al (8) recently reviewed information quality in peer review versus GLP studies. The authors note that GLP is best at data quality, documentation and ensuring reproducibility, but is not "foolproof."…”

“…Journal peer reviewed studies bring forth new science and data, but peer review "…is currently not a reliable process for establishing data quality, nor does it represent an unequivocal metric for establishing relative merit of data or interpretation and conclusions drawn from those data." (8). The authors conclude that neither process (GLP or peer-review) can stand alone in determining the relevancy or reliability of a study to be used in a risk assessment process, but that only a sound weight of evidence scheme can fulfill this need.…”

Effects of Herbicides on Fish

“…These data are provided by the registrant and, for the required data on fish (one warm-water and coldwater), the studies must be conducted according to guidelines such as OECD test method 203 (OECD, 1992), under good laboratory practice (GLP), and with quality assurance and quality control (QA/QC). Studies conducted under GLP are well documented, and the quality control is generally much more rigorous than papers published in peer-reviewed journals; these studies provide the most reliable toxicity data (McCarty et al, 2012). We have used these and other data from the open literature to characterize acute toxicity values for herbicides in fish.…”

Assessment of PBTs in the European Union: a critical assessment of the proposed evaluation scheme with reference to plant protection products

“…Because guidelines studies follow consistent protocols, data can be more reliably compared between compounds and the criteria. In addition, GLP with QA/QC enhances the transparency and veracity of the data [32]. For this reason, these studies are the most preferred; however, non-guideline studies conducted in the spirit of GLP can also be included (Table 2).…”