Loading…
An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies
The concurrent control group is the most important reference for the interpretation of toxicity studies. However, pooled information on control animals from independent studies, i.e., historical control data (HCD), is also used for the interpretation of results. Currently, an overview on actual HCD...
Saved in:
Published in: | Regulatory toxicology and pharmacology 2024-12, Vol.154, p.105724, Article 105724 |
---|---|
Main Authors: | , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
cited_by | |
---|---|
cites | cdi_FETCH-LOGICAL-c284t-ed7827c77f9ef43f3d28f534a208ad30bd38fcc33abbc94e3849cb67484ca6533 |
container_end_page | |
container_issue | |
container_start_page | 105724 |
container_title | Regulatory toxicology and pharmacology |
container_volume | 154 |
creator | Zarn, Jürg A. König, Sebastian L.B. Shaw, Holly V. Geiser, H. Christoph |
description | The concurrent control group is the most important reference for the interpretation of toxicity studies. However, pooled information on control animals from independent studies, i.e., historical control data (HCD), is also used for the interpretation of results. Currently, an overview on actual HCD use in regulatory toxicology is lacking. Therefore, we evaluated the HCD use of the Joint FAO/WHO Meeting on Pesticide Residues from 2004 to 2021 and compared it with recommendations in regulatory guidelines and in the literature. We found that HCD was used routinely and exclusively to avoid potential false positive decisions regarding the treatment-relatedness of effects, mostly using the HCD range, i.e., the most extreme values, as a benchmark. HCD were not used to avoid potential false negative decisions or for quality control of the index study. The central assumption of the HCD use, namely that the HCD and control group of the index study follow the same underlying distribution because they are samples of the same data generation process, was not investigated, although numerous factors potentially contribute to effect variation between the different control groups pooled in the HCD. We recommend that the existing guidelines be revised to improve the robustness and transparency of toxicological assessments.
•HCD are routinely used to evaluate regulatory pesticide toxicity studies.•The maximum value of HCD range is the main reference value used.•Main purpose of its use is to scrutinize potentially false positive findings.•HCD are not used to identify potentially false negative findings.•HCD are not used for quality control purposes. |
doi_str_mv | 10.1016/j.yrtph.2024.105724 |
format | article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3118471695</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S027323002400165X</els_id><sourcerecordid>3118471695</sourcerecordid><originalsourceid>FETCH-LOGICAL-c284t-ed7827c77f9ef43f3d28f534a208ad30bd38fcc33abbc94e3849cb67484ca6533</originalsourceid><addsrcrecordid>eNp9kEtP3DAQgK0KBMvjFyAhH3vJ1q_EzoEDQm2phNRLOVuOPel6lY0Xj1M1_54sS3vkNKPRN6-PkBvO1pzx5st2Peey36wFE2qp1FqoT2TFWdtUTLT1CVkxoWUlJGPn5AJxyxgTxugzci5bJZqGyxUZ7kfqRjfMGJGmnpYN0AnhkG4ilpSjdwP1aSw5DTS44mgc3yiHCIg7GMsBzvB7GtzCz3QPWKKPAWhJf5ekzBTLFCLgFTnt3YBw_R4vyfO3r78eHqunn99_PNw_VV4YVSoI2gjtte5b6JXsZRCmr6VyghkXJOuCNL33Urqu860CaVTru0Yro7xraikvyefj3H1OL9Nyjt1F9DAMboQ0oZWcG6V509YLKo-ozwkxQ2_3Oe5cni1n9qDZbu2bZnvQbI-al67b9wVTt4Pwv-ef1wW4OwKwvPknQrboI4weQszgiw0pfrjgFUeXkXU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3118471695</pqid></control><display><type>article</type><title>An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies</title><source>ScienceDirect Journals</source><creator>Zarn, Jürg A. ; König, Sebastian L.B. ; Shaw, Holly V. ; Geiser, H. Christoph</creator><creatorcontrib>Zarn, Jürg A. ; König, Sebastian L.B. ; Shaw, Holly V. ; Geiser, H. Christoph</creatorcontrib><description>The concurrent control group is the most important reference for the interpretation of toxicity studies. However, pooled information on control animals from independent studies, i.e., historical control data (HCD), is also used for the interpretation of results. Currently, an overview on actual HCD use in regulatory toxicology is lacking. Therefore, we evaluated the HCD use of the Joint FAO/WHO Meeting on Pesticide Residues from 2004 to 2021 and compared it with recommendations in regulatory guidelines and in the literature. We found that HCD was used routinely and exclusively to avoid potential false positive decisions regarding the treatment-relatedness of effects, mostly using the HCD range, i.e., the most extreme values, as a benchmark. HCD were not used to avoid potential false negative decisions or for quality control of the index study. The central assumption of the HCD use, namely that the HCD and control group of the index study follow the same underlying distribution because they are samples of the same data generation process, was not investigated, although numerous factors potentially contribute to effect variation between the different control groups pooled in the HCD. We recommend that the existing guidelines be revised to improve the robustness and transparency of toxicological assessments.
•HCD are routinely used to evaluate regulatory pesticide toxicity studies.•The maximum value of HCD range is the main reference value used.•Main purpose of its use is to scrutinize potentially false positive findings.•HCD are not used to identify potentially false negative findings.•HCD are not used for quality control purposes.</description><identifier>ISSN: 0273-2300</identifier><identifier>ISSN: 1096-0295</identifier><identifier>EISSN: 1096-0295</identifier><identifier>DOI: 10.1016/j.yrtph.2024.105724</identifier><identifier>PMID: 39426613</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Animals ; Chemical risk assessment ; Control limit ; Guidelines as Topic ; Hazard identification ; Historical control data ; Humans ; Intergroup variability ; Pesticide Residues - toxicity ; Pesticides - toxicity ; Prediction interval ; Reference range ; Risk Assessment ; Toxicity Tests - standards</subject><ispartof>Regulatory toxicology and pharmacology, 2024-12, Vol.154, p.105724, Article 105724</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c284t-ed7827c77f9ef43f3d28f534a208ad30bd38fcc33abbc94e3849cb67484ca6533</cites><orcidid>0000-0003-2216-560X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39426613$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zarn, Jürg A.</creatorcontrib><creatorcontrib>König, Sebastian L.B.</creatorcontrib><creatorcontrib>Shaw, Holly V.</creatorcontrib><creatorcontrib>Geiser, H. Christoph</creatorcontrib><title>An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies</title><title>Regulatory toxicology and pharmacology</title><addtitle>Regul Toxicol Pharmacol</addtitle><description>The concurrent control group is the most important reference for the interpretation of toxicity studies. However, pooled information on control animals from independent studies, i.e., historical control data (HCD), is also used for the interpretation of results. Currently, an overview on actual HCD use in regulatory toxicology is lacking. Therefore, we evaluated the HCD use of the Joint FAO/WHO Meeting on Pesticide Residues from 2004 to 2021 and compared it with recommendations in regulatory guidelines and in the literature. We found that HCD was used routinely and exclusively to avoid potential false positive decisions regarding the treatment-relatedness of effects, mostly using the HCD range, i.e., the most extreme values, as a benchmark. HCD were not used to avoid potential false negative decisions or for quality control of the index study. The central assumption of the HCD use, namely that the HCD and control group of the index study follow the same underlying distribution because they are samples of the same data generation process, was not investigated, although numerous factors potentially contribute to effect variation between the different control groups pooled in the HCD. We recommend that the existing guidelines be revised to improve the robustness and transparency of toxicological assessments.
•HCD are routinely used to evaluate regulatory pesticide toxicity studies.•The maximum value of HCD range is the main reference value used.•Main purpose of its use is to scrutinize potentially false positive findings.•HCD are not used to identify potentially false negative findings.•HCD are not used for quality control purposes.</description><subject>Animals</subject><subject>Chemical risk assessment</subject><subject>Control limit</subject><subject>Guidelines as Topic</subject><subject>Hazard identification</subject><subject>Historical control data</subject><subject>Humans</subject><subject>Intergroup variability</subject><subject>Pesticide Residues - toxicity</subject><subject>Pesticides - toxicity</subject><subject>Prediction interval</subject><subject>Reference range</subject><subject>Risk Assessment</subject><subject>Toxicity Tests - standards</subject><issn>0273-2300</issn><issn>1096-0295</issn><issn>1096-0295</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kEtP3DAQgK0KBMvjFyAhH3vJ1q_EzoEDQm2phNRLOVuOPel6lY0Xj1M1_54sS3vkNKPRN6-PkBvO1pzx5st2Peey36wFE2qp1FqoT2TFWdtUTLT1CVkxoWUlJGPn5AJxyxgTxugzci5bJZqGyxUZ7kfqRjfMGJGmnpYN0AnhkG4ilpSjdwP1aSw5DTS44mgc3yiHCIg7GMsBzvB7GtzCz3QPWKKPAWhJf5ekzBTLFCLgFTnt3YBw_R4vyfO3r78eHqunn99_PNw_VV4YVSoI2gjtte5b6JXsZRCmr6VyghkXJOuCNL33Urqu860CaVTru0Yro7xraikvyefj3H1OL9Nyjt1F9DAMboQ0oZWcG6V509YLKo-ozwkxQ2_3Oe5cni1n9qDZbu2bZnvQbI-al67b9wVTt4Pwv-ef1wW4OwKwvPknQrboI4weQszgiw0pfrjgFUeXkXU</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Zarn, Jürg A.</creator><creator>König, Sebastian L.B.</creator><creator>Shaw, Holly V.</creator><creator>Geiser, H. Christoph</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2216-560X</orcidid></search><sort><creationdate>202412</creationdate><title>An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies</title><author>Zarn, Jürg A. ; König, Sebastian L.B. ; Shaw, Holly V. ; Geiser, H. Christoph</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c284t-ed7827c77f9ef43f3d28f534a208ad30bd38fcc33abbc94e3849cb67484ca6533</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Animals</topic><topic>Chemical risk assessment</topic><topic>Control limit</topic><topic>Guidelines as Topic</topic><topic>Hazard identification</topic><topic>Historical control data</topic><topic>Humans</topic><topic>Intergroup variability</topic><topic>Pesticide Residues - toxicity</topic><topic>Pesticides - toxicity</topic><topic>Prediction interval</topic><topic>Reference range</topic><topic>Risk Assessment</topic><topic>Toxicity Tests - standards</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zarn, Jürg A.</creatorcontrib><creatorcontrib>König, Sebastian L.B.</creatorcontrib><creatorcontrib>Shaw, Holly V.</creatorcontrib><creatorcontrib>Geiser, H. Christoph</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Regulatory toxicology and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zarn, Jürg A.</au><au>König, Sebastian L.B.</au><au>Shaw, Holly V.</au><au>Geiser, H. Christoph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies</atitle><jtitle>Regulatory toxicology and pharmacology</jtitle><addtitle>Regul Toxicol Pharmacol</addtitle><date>2024-12</date><risdate>2024</risdate><volume>154</volume><spage>105724</spage><pages>105724-</pages><artnum>105724</artnum><issn>0273-2300</issn><issn>1096-0295</issn><eissn>1096-0295</eissn><abstract>The concurrent control group is the most important reference for the interpretation of toxicity studies. However, pooled information on control animals from independent studies, i.e., historical control data (HCD), is also used for the interpretation of results. Currently, an overview on actual HCD use in regulatory toxicology is lacking. Therefore, we evaluated the HCD use of the Joint FAO/WHO Meeting on Pesticide Residues from 2004 to 2021 and compared it with recommendations in regulatory guidelines and in the literature. We found that HCD was used routinely and exclusively to avoid potential false positive decisions regarding the treatment-relatedness of effects, mostly using the HCD range, i.e., the most extreme values, as a benchmark. HCD were not used to avoid potential false negative decisions or for quality control of the index study. The central assumption of the HCD use, namely that the HCD and control group of the index study follow the same underlying distribution because they are samples of the same data generation process, was not investigated, although numerous factors potentially contribute to effect variation between the different control groups pooled in the HCD. We recommend that the existing guidelines be revised to improve the robustness and transparency of toxicological assessments.
•HCD are routinely used to evaluate regulatory pesticide toxicity studies.•The maximum value of HCD range is the main reference value used.•Main purpose of its use is to scrutinize potentially false positive findings.•HCD are not used to identify potentially false negative findings.•HCD are not used for quality control purposes.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>39426613</pmid><doi>10.1016/j.yrtph.2024.105724</doi><orcidid>https://orcid.org/0000-0003-2216-560X</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0273-2300 |
ispartof | Regulatory toxicology and pharmacology, 2024-12, Vol.154, p.105724, Article 105724 |
issn | 0273-2300 1096-0295 1096-0295 |
language | eng |
recordid | cdi_proquest_miscellaneous_3118471695 |
source | ScienceDirect Journals |
subjects | Animals Chemical risk assessment Control limit Guidelines as Topic Hazard identification Historical control data Humans Intergroup variability Pesticide Residues - toxicity Pesticides - toxicity Prediction interval Reference range Risk Assessment Toxicity Tests - standards |
title | An analysis of the use of historical control data in the assessment of regulatory pesticide toxicity studies |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T23%3A23%3A23IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=An%20analysis%20of%20the%20use%20of%20historical%20control%20data%20in%20the%20assessment%20of%20regulatory%20pesticide%20toxicity%20studies&rft.jtitle=Regulatory%20toxicology%20and%20pharmacology&rft.au=Zarn,%20J%C3%BCrg%20A.&rft.date=2024-12&rft.volume=154&rft.spage=105724&rft.pages=105724-&rft.artnum=105724&rft.issn=0273-2300&rft.eissn=1096-0295&rft_id=info:doi/10.1016/j.yrtph.2024.105724&rft_dat=%3Cproquest_cross%3E3118471695%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c284t-ed7827c77f9ef43f3d28f534a208ad30bd38fcc33abbc94e3849cb67484ca6533%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3118471695&rft_id=info:pmid/39426613&rfr_iscdi=true |