Scientific integrity issues in Environmental Toxicology and Chemistry: Improving research reproducibility, credibility, and transparency

Mebane, Christopher A.; Sumpter, John P.; Fairbrother, Anne; Augspurger, Thomas P.; Canfield, Timothy J.; Goodfellow, William L.; Guiney, Patrick D.; LeHuray, Anne; Maltby, Lorraine; Mayfield, David; McLaughlin, Michael J.; Ortego, Lisa S.; Schlekat, Tamar; Scroggins, Richard P.; Verslycke, Tim

doi:10.1002/ieam.4119

“…It is now widely accepted that a significant proportion of published research is not reproducible, a situation sometimes called the 'reproducibility crisis'(47, 48) (49). Reasons include: perverse incentives on research scientists to publish 'exciting' research and a general lack of training of researchers (50). Two common problems are poor experimental design and bias (51).…”

Section: Data Quality and The Relevance Of Research Topicsmentioning

confidence: 99%

Learning from the past and considering the future of chemicals in the environment

Johnson

¹

,

Jin

²

,

Nakada

³

et al. 2020

Science

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Knowledge of the hazards and associated risks from chemicals discharged to the environment has grown considerably over the past 40 years. This improving awareness stems from advances in our ability to measure chemicals at low environmental concentrations, recognition of a range of effects on organisms, and a worldwide growth in expertise. Environmental scientists and companies have learned from the experiences of the past; in theory, the next generation of chemicals will cause less acute toxicity and be less environmentally persistent and bioaccumulative. However, researchers still struggle to establish whether the nonlethal effects associated with some modern chemicals and substances will have serious consequences for wildlife. Obtaining the resources to address issues associated with chemicals in the environment remains a challenge.

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“…6,[19][20][21][22][23][24][25][26][27] As was done for a recent workshop focused on fatty acids, 28 we assemble here relevant prior publications citing critical or state-of-the-art approaches drawn from a breadth of NP research and related disciplines, and address in greater depth NP-related topics that were specific foci of the workshop. Past efforts to enhance rigor in NP research include the NCCIH Policy on Natural Product Integrity 18 as well as numerous guidance documents addressing identification, reproducibility, study design, and execution, as well as conflict of interest issues.…”

Section: Focus and Objectivesmentioning

confidence: 99%

“…Past efforts to enhance rigor in NP research include the NCCIH Policy on Natural Product Integrity 18 as well as numerous guidance documents addressing identification, reproducibility, study design, and execution, as well as conflict of interest issues. 6,[19][20][21][22][23][24][25][26][27] As was done for a recent workshop focused on fatty acids, 28 we assemble here relevant prior publications citing critical or state-of-the-art approaches drawn from a breadth of NP research and related disciplines, and address in greater depth NP-related topics that were specific foci of the workshop.…”

Section: Focus and Objectivesmentioning

confidence: 99%

Improving natural product research translation: From source to clinical trial

Sorkin

¹

,

Kuszak

²

,

Bloss

³

et al. 2019

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a Septe mber, 2018 trans disci plina ry workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research. K E Y W O R D S clinical predictive validity, dietary supplements, model systems, rigor and replicability, value of information | 43 SORKIN et al.still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result. Each interventional trial represents a substantial investment, with well-powered Phase III CTs typically consuming more than $10 million and many person-years. 9,10 Additionally, as time and funds are limited, and participant pools may also be constrained, a decision to invest in a CT often precludes pursuing other research questions, 11 which may provide more useful public health-relevant knowledge than an RCT with an insufficient evidence base.

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“…Past efforts to enhance rigor in NP research include the NCCIH Policy on Natural Product Integrity (17) as well as numerous guidance documents addressing, identification, reproducibility, study design, and execution, as well as conflict of interest issues (5,(18)(19)(20)(21)(22)(23)(24)(25)(26). As was done for a recent workshop focused on fatty acids (27), we assemble here relevant prior publications citing critical or state-of-the-art approaches drawn from a breadth of NP research and related disciplines, and address in greater depth NP-related topics that were specific foci of the workshop.…”

Section: Focus and Objectivesmentioning

confidence: 99%

Improving Natural Product Research Translation: from Source to Clinical Trial

Sorkin¹,

Kuszak²,

Fukagawa³

et al. 2019

Preprint

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a https://events-support.com/events/Natural_Product_Clinical_Trials. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research.

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Scientific integrity issues in Environmental Toxicology and Chemistry: Improving research reproducibility, credibility, and transparency

Cited by 41 publications

References 197 publications

Learning from the past and considering the future of chemicals in the environment

Learning from the past and considering the future of chemicals in the environment

Improving natural product research translation: From source to clinical trial

Improving Natural Product Research Translation: from Source to Clinical Trial

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