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- Laboratory animals (6)
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- Animal experimentation (1)
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Articles 1 - 20 of 20
Full-Text Articles in Design of Experiments and Sample Surveys
Acute Toxicity Testing Without Animals: More Scientific And Less Of A Gamble, Gillian R. Langley
Acute Toxicity Testing Without Animals: More Scientific And Less Of A Gamble, Gillian R. Langley
Gill Langley, PhD
In this report, we argue specifically that acute toxicity data should not be sought from animal tests. The underlying principle of such tests on rats and mice is that the results can be effectively extrapolated to humans. In fact, after nearly 80 years of use of these tests, the predictivity of rodent data for human acute toxic effects has been disputed but never proven.
Non-Human Primates In Neuroscience Research: The Case Against Its Scientific Necessity, Jarrod Bailey, Katy Taylor
Non-Human Primates In Neuroscience Research: The Case Against Its Scientific Necessity, Jarrod Bailey, Katy Taylor
Jarrod Bailey, PhD
Public opposition to non-human primate (NHP) experiments is significant, yet those who defend them cite minimal harm to NHPs and substantial human benefit. Here we review these claims of benefit, specifically in neuroscience, and show that: a) there is a default assumption of their human relevance and benefit, rather than robust evidence; b) their human relevance and essential contribution and necessity are wholly overstated; c) the contribution and capacity of non-animal investigative methods are greatly understated; and d) confounding issues, such as species differences and the effects of stress and anaesthesia, are usually overlooked. This is the case in NHP …
An Assessment Of The Role Of Chimpanzees In Aids Vaccine Research, Jarrod Bailey
An Assessment Of The Role Of Chimpanzees In Aids Vaccine Research, Jarrod Bailey
Jarrod Bailey, PhD
Prior to Simian Immunodeficiency Virus (SIV)-infected macaques becoming the ‘model of choice’ in the 1990s, chimpanzees were widely used in AIDS vaccine research and testing. Faced with the continued failure to develop an effective human vaccine, some scientists are calling for a return to their widespread use. To assess the past and potential future contribution of chimpanzees to AIDS vaccine development, databases and published literature were systematically searched to compare the results of AIDS vaccine trials in chimpanzees with those of human clinical trials, and to determine whether the chimpanzee trials were predictive of the human response. Protective and/or therapeutic …
Institutional Animal Care And Use Committees: A Flawed Paradigm Or Work In Progress?, John P. Gluck, F. Barbara Orlans
Institutional Animal Care And Use Committees: A Flawed Paradigm Or Work In Progress?, John P. Gluck, F. Barbara Orlans
John P. Gluck, PhD
In his challenging article, Steneck (1997) criticized the creation of the Institutional Animal Care and Use Committee (IACUC) system established by the 1985 amendments to the Animal Welfare Act. He saw the IACUC review and approval of biomedical and behavioral research with animals as an unnecessary "reassignment" of duties from existing animal care programs to IACUC committees. He argued that the committees are unable to do the work expected of them for basically three reasons: (a) the membership lacks the expertise in matters relevant to animal research and care, (b) there exists an inherent and disabling conflict of interest, and …
Food For Thought … Mechanistic Validation, Thomas Hartung, Sebastian Hoffman, Martin Stephens
Food For Thought … Mechanistic Validation, Thomas Hartung, Sebastian Hoffman, Martin Stephens
Martin Stephens, PhD
Validation of new approaches in regulatory toxicology is commonly defined as the independent assessment of the reproducibility and relevance (the scientific basis and predictive capacity) of a test for a particular purpose. In large ring trials, the emphasis to date has been mainly on reproducibility and predictive capacity (comparison to the traditional test) with less attention given to the scientific or mechanistic basis. Assessing predictive capacity is difficult for novel approaches (which are based on mechanism), such as pathways of toxicity or the complex networks within the organism (systems toxicology). This is highly relevant for implementing Toxicology for the 21st …
Noncompliance With Public Health Service (Phs) Policy On Humane Care And Use Of Laboratory Animals: An Exploratory Analysis, Leah M. Gomez, Kathleen Conlee, Martin Stephens
Noncompliance With Public Health Service (Phs) Policy On Humane Care And Use Of Laboratory Animals: An Exploratory Analysis, Leah M. Gomez, Kathleen Conlee, Martin Stephens
Martin Stephens, PhD
The National Institutes of Health (NIH) is a major biomedical research-funding body in the United States. Approximately 40% of NIH-funded research involves experimentation on nonhuman animals (Monastersky, 2008). Institutions that conduct animal research with NIH funds must adhere to the Public Health Service (PHS) care and use standards of the Office of Laboratory Animal Welfare (OLAW, 2002a). Institutions deviating significantly from the PHS’s animal care and use standards must report these incidents to the NIH’s OLAW. This study is an exploratory analysis of all the significant deviations reported by animal-research facilities to OLAW during a 3-month period. The study identifies …
Addressing Distress And Pain In Animal Research: The Veterinary, Research, Societal, Regulatory And Ethical Contexts For Moving Forward, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Addressing Distress And Pain In Animal Research: The Veterinary, Research, Societal, Regulatory And Ethical Contexts For Moving Forward, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Martin Stephens, PhD
While most people recognize that biomedical scientists are searching for knowledge that will improve the health of humans and animals, the image of someone deliberately causing harm to an animal in order to produce data that may lead to some future benefit has always prompted an uncomfortable reaction outside the laboratory. However, proponents of animal research have usually justified the practice by reference to greater benefits (new knowledge and medical treatments) over lesser costs (in animal suffering and death). Given that one of the costs of animal research is the suffering experienced by the animals, the goal of eliminating distress …
The Usefulness Of Systematic Reviews Of Animal Experiments For The Design Of Preclinical And Clinical Studies, Rob B.M. De Vries, Kimberley E. Weaver, Marc T. Avey, Martin Stephens, Emily S. Sena, Marlies Leenaars
The Usefulness Of Systematic Reviews Of Animal Experiments For The Design Of Preclinical And Clinical Studies, Rob B.M. De Vries, Kimberley E. Weaver, Marc T. Avey, Martin Stephens, Emily S. Sena, Marlies Leenaars
Martin Stephens, PhD
The question of how animal studies should be designed, conducted, and analyzed remains underexposed in societal debates on animal experimentation. This is not only a scientific but also amoral question. After all, if animal experiments are not appropriately designed, conducted, and analyzed, the results produced are unlikely to be reliable and the animals have in effect been wasted. In this article, we focus on one particular method to address this moral question, namely systematic reviews of previously performed animal experiments. We discuss how the design, conduct, and analysis of future (animal and human) experiments may be optimized through such systematic …
The Minimization Of Research Animal Distress And Pain: Conclusions And Recommendations, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
The Minimization Of Research Animal Distress And Pain: Conclusions And Recommendations, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Martin Stephens, PhD
While the attention given to preventing, assessing, and alleviating pain in research animals has increased noticeably in recent decades, much remains to be done both in terms of implementing best practices and conducting studies to answer outstanding questions. In contrast, the attention to distress (particularly non-pain induced distress) has shown no comparable increase. There are many reasons for this discrepancy, including the conceptual untidiness of the distress concept, the paucity of pharmacological treatments for distress, and perceived lack of regulatory emphasis on distress. These are challenges that need to be addressed and overcome. This book is intended to help meet …
Animal Model Research: The Apples And Oranges Quandary, Kenneth J. Shapiro
Animal Model Research: The Apples And Oranges Quandary, Kenneth J. Shapiro
Kenneth J. Shapiro, PhD
In this paper, I explore the premises underlying the problem of the evaluation of animal models. I argue that the presence of similarities and differences between the model and the modelled, although historically and currently a dominant antinomy framing evaluation, is not a bottom-line consideration. What is critical is 1) whether we learn and 2) whether we improve treatment through the animal model research. Similarity between model and modelled and the closely related concept of validity are not coterminus with these critical evaluative measures. In fact, differences between the model and modelled also can provide impetus to new understanding and …
Evaluation Of Animal Model Research, Kenneth J. Shapiro
Evaluation Of Animal Model Research, Kenneth J. Shapiro
Kenneth J. Shapiro, PhD
It is argued that a concept of evaluation of animal models that is broader and more useful than validation is available. Productive generativity refers to the degree to which a model furthers understanding and leads to more-effective treatment interventions. Results of the application of this novel evaluative frame to several animal models of eating disorders show that this animal-based research has not been productive. The question of the relation between clinic and animal laboratory is discussed.
Expectations For Methodology And Translation Of Animal Research: A Survey Of Health Care Workers, Ari Joffe, Meredith Bara, Natalie Anton, Nathan Nobis
Expectations For Methodology And Translation Of Animal Research: A Survey Of Health Care Workers, Ari Joffe, Meredith Bara, Natalie Anton, Nathan Nobis
Nathan M. Nobis, PhD
Background: Health care workers (HCW) often perform, promote, and advocate use of public funds for animal research (AR); therefore, an awareness of the empirical costs and benefits of animal research is an important issue for HCW. We aim to determine what health-care-workers consider should be acceptable standards of AR methodology and translation rate to humans. Methods: After development and validation, an e-mail survey was sent to all pediatricians and pediatric intensive care unit nurses and respiratory-therapists (RTs) affiliated with a Canadian University. We presented questions about demographics, methodology of AR, and expectations from AR. Responses of pediatricians and nurses/RTs were …
Addressing Distress And Pain In Animal Research: The Veterinary, Research, Societal, Regulatory And Ethical Contexts For Moving Forward, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Addressing Distress And Pain In Animal Research: The Veterinary, Research, Societal, Regulatory And Ethical Contexts For Moving Forward, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Andrew N. Rowan, DPhil
While most people recognize that biomedical scientists are searching for knowledge that will improve the health of humans and animals, the image of someone deliberately causing harm to an animal in order to produce data that may lead to some future benefit has always prompted an uncomfortable reaction outside the laboratory. However, proponents of animal research have usually justified the practice by reference to greater benefits (new knowledge and medical treatments) over lesser costs (in animal suffering and death). Given that one of the costs of animal research is the suffering experienced by the animals, the goal of eliminating distress …
The Minimization Of Research Animal Distress And Pain: Conclusions And Recommendations, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
The Minimization Of Research Animal Distress And Pain: Conclusions And Recommendations, Kathleen Conlee, Martin Stephens, Andrew N. Rowan
Andrew N. Rowan, DPhil
While the attention given to preventing, assessing, and alleviating pain in research animals has increased noticeably in recent decades, much remains to be done both in terms of implementing best practices and conducting studies to answer outstanding questions. In contrast, the attention to distress (particularly non-pain induced distress) has shown no comparable increase. There are many reasons for this discrepancy, including the conceptual untidiness of the distress concept, the paucity of pharmacological treatments for distress, and perceived lack of regulatory emphasis on distress. These are challenges that need to be addressed and overcome. This book is intended to help meet …
The Validity Of Animal Experiments In Medical Research, Gill Langley
The Validity Of Animal Experiments In Medical Research, Gill Langley
Gill Langley, PhD
Other animals, such as mice, rats, rabbits, dogs and monkeys, are widely used as surrogates for humans in fundamental medical research. This involves creating disorders in animals by chemical, surgical or genetic means, with the aim of mimicking selected aspects of human illnesses. It is a truism that any model or surrogate is not identical to the target being modelled. So, in medical research, experiments using animals or cell cultures or even healthy volunteers instead of patients (being the target population with the target illness) will inevitably have limitations, although these will be greater or lesser depending on the model.
Laboratory Routines Cause Animal Stress, Jonathan P. Balcombe, Neal D. Barnard, Chad Sandusky
Laboratory Routines Cause Animal Stress, Jonathan P. Balcombe, Neal D. Barnard, Chad Sandusky
Jonathan Balcombe, PhD
Eighty published studies were appraised to document the potential stress associated with three routine laboratory procedures commonly performed on animals: handling, blood collection, and orogastric gavage. We defined handling as any non-invasive manipulation occurring as part of routine husbandry, including lifting an animal and cleaning or moving an animal's cage. Significant changes in physiologic parameters correlated with stress (e.g., serum or plasma concentrations of corticosterone, glucose, growth hormone or prolactin, heart rate, blood pressure, and behavior) were associated with all three procedures in multiple species in the studies we examined. The results of these studies demonstrated that animals responded with …
Adaptive Pair-Matching In The Search Trial And Estimation Of The Intervention Effect, Laura Balzer, Maya L. Petersen, Mark J. Van Der Laan
Adaptive Pair-Matching In The Search Trial And Estimation Of The Intervention Effect, Laura Balzer, Maya L. Petersen, Mark J. Van Der Laan
Laura B. Balzer
In randomized trials, pair-matching is an intuitive design strategy to protect study validity and to potentially increase study power. In a common design, candidate units are identified, and their baseline characteristics used to create the best n/2 matched pairs. Within the resulting pairs, the intervention is randomized, and the outcomes measured at the end of follow-up. We consider this design to be adaptive, because the construction of the matched pairs depends on the baseline covariates of all candidate units. As consequence, the observed data cannot be considered as n/2 independent, identically distributed (i.i.d.) pairs of units, as current practice assumes. …
Estimating The Impact Of Community-Level Interventions: The Search Trial And Hiv Prevention In Sub-Saharan Africa, Laura Balzer, Maya Petersen, Joshua Schwab, Mark Van Der Laan
Estimating The Impact Of Community-Level Interventions: The Search Trial And Hiv Prevention In Sub-Saharan Africa, Laura Balzer, Maya Petersen, Joshua Schwab, Mark Van Der Laan
Laura B. Balzer
Evaluation of community level interventions to prevent HIV infection presents significant methodological challenges. Even when it is feasible to randomly assign a treatment versus control level of the intervention to each community in a sample, measurement of incident HIV infection remains difficult. In this talk we describe an experimental design developed for the SEARCH Trial, a large community randomized trial that will evaluate the impact of expanded treatment on incident HIV and other outcomes. Regular community-wide testing campaigns are conducted and a random sample of community members who fail to attend a campaign are tracked. The data generated by this …
Why Match In Individually And Cluster Randomized Trials?, Laura B. Balzer, Maya L. Petersen, Mark J. Van Der Laan
Why Match In Individually And Cluster Randomized Trials?, Laura B. Balzer, Maya L. Petersen, Mark J. Van Der Laan
Laura B. Balzer
The decision to match individuals or clusters in randomized trials is motivated by both practical and statistical concerns. Matching protects against chance imbalances in baseline covariate distributions and is thought to improve study credibility. Matching is also implemented to increase study power. This article compares the asymptotic efficiency of the pair-matched design, where units are matched on baseline covariates and the treatment randomized within pairs, to the independent design, where units are randomly paired and the treatment randomized within pairs. We focus on estimating the average treatment effect and use the efficient influence curve to understand the information provided by …
Why Match In Individually And Cluster Randomized Trials?, Laura Balzer, Maya Petersen, Mark Van Der Laan
Why Match In Individually And Cluster Randomized Trials?, Laura Balzer, Maya Petersen, Mark Van Der Laan
Laura B. Balzer
The decision to match individuals or clusters in randomized trials is motivated by both practical and statistical concerns. Matching protects against chance imbalances in baseline covariate distributions and is thereby thought to improve study credibility. Matching is also implemented to increase study power. Analogue to Rose and van der Laan (2009), this article investigates the asymptotic efficiency of pair-matching individuals or clusters relative to not matching in randomized trials. We focus on estimating the average treatment effect. We use the efficient influence curve to understand the information provided by each design for estimation of the target causal parameter. Our approach …