Use of Systematic Review to Support Regulatory Decision-Making

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By Logeswari Ponnusamy posted 03-15-2018 06:38

  

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A systematic review (SR) is a secondary research process (research on research) and is gaining popularity in regulatory space lately. The 2018 SOT Annual Meeting and ToxExpo Informational Session “Moving Beyond Theory to the Use of Systematic Review to Support Regulatory Decision Making for Evidence-Based Risk Assessment” focused on the systematic review process and evidence-based methodologies (Big “S” and Big “R”) in toxicology regulator decision making. The session covered the systematic review framework being developed and/ or used by various agencies, including the European Food Safety Authority (EFSA), US Environmental Protection Agency (US EPA), Texas Commission on Environmental Quality (TCEQ), and ToxStrategies, and addressed the ongoing global efforts and other opportunities available to advance the process of systematic review in toxicology. The importance of systematic review in toxicology was highlighted by citing the recent publication “A Primer on Systematic Reviews in Toxicology,” which was authored by some of the speakers and many other experts in toxicology.

Daniele Wikoff, ToxStrategies, introduced the integration of systematic review to support the development of health-based benchmarks (e.g., acceptable daily intakes, reference doses, etc.) in chemical risk assessment. Frameworks initially developed in the field of medicine have been applied to address toxicology questions while there are new tools being developed. SR involves the following workflow process: feasible problem formulation, protocol development, identifying evidence base, individual study assessment, body of evidence assessment, and comprehensive reporting. Challenges, such as how do you decide when to do a systematic review and on what and how the process for critical appraisal compares with traditional study techniques and principles, were pointed out.

Elisa Aiassa, EFSA, discussed the SR process in support of chemical risk assessment within the EFSA. EFSA’s “PROMETHEUS” project (Promoting Methods for Evidence Use in Scientific Assessment) focuses on minimizing bias, methodological rigor, and transparency when using various evidence in decision making. EFSA carries out SR to address one or more sub-questions within risk assessment rather than reviewing the entire component. The framework of EFSA’s SR was described using bisphenol A (BPA) as an example.

Kristina Thayer, US EPA, discussed the SR process in support of chemical risk assessment within the US EPA. According to Dr. Thayer, front-end time investment that leads to downstream efficiencies and soliciting feedback early in the process from various stakeholders are important in the process of SR as they help to formulate a clear and feasible question.

Jessica Myers, TCEQ, provided an overview of guidelines for performing systematic reviews in the development of toxicity factors. TCEQ develops toxicity factors for the majority of chemicals used in Texas. TCEQ has its own peer-reviewed guidelines for developing toxicity factors, and SR does not start with a defined question as little is known about a chemical prior to it.

Katya Tsaioun, Johns Hopkins Bloomberg School of Public Health Evidence-Based Toxicology Collaboration, discussed the global efforts and available opportunities to advance the field of systematic review in regulatory decision making. Some of the key areas of concern in the SR process were laid out, which include a problem in conducting and reporting standards, how flawed reviews could impact the policymaking in a big picture, and why harmonizing the SR process is important in regulatory decision making.

Overall, the session was very informative and well-attended. With growing attention towards toxicology in the regulatory space, engaging the scientific community is a key to conducting and reporting systematic review for better, impartial, and transparent decision making.

This blog was prepared by an SOT Reporter. SOT Reporters are SOT members who volunteer to write about sessions and events they attend during the SOT Annual Meeting and ToxExpo. If you are interested in participating in the SOT Reporter program in the future, please email SOT Communications Director Michelle Werts.

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