Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments
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{"title"=>"Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments", "type"=>"journal", "authors"=>[{"first_name"=>"Valerie C.", "last_name"=>"Henderson", "scopus_author_id"=>"55359177100"}, {"first_name"=>"Jonathan", "last_name"=>"Kimmelman", "scopus_author_id"=>"6603581252"}, {"first_name"=>"Dean", "last_name"=>"Fergusson", "scopus_author_id"=>"7102364909"}, {"first_name"=>"Jeremy M.", "last_name"=>"Grimshaw", "scopus_author_id"=>"34769948000"}, {"first_name"=>"Dan G.", "last_name"=>"Hackam", "scopus_author_id"=>"7005478311"}], "year"=>2013, "source"=>"PLoS Medicine", "identifiers"=>{"scopus"=>"2-s2.0-84881240391", "doi"=>"10.1371/journal.pmed.1001489", "sgr"=>"84881240391", "arxiv"=>"arXiv:1011.1669v3", "isbn"=>"1549-1676", "pmid"=>"23935460", "issn"=>"15491277", "pui"=>"369514195"}, "id"=>"6a6a46f2-b893-3443-9c55-101cb876b6a0", "abstract"=>"BACKGROUND: The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address. METHODS AND FINDINGS: We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria--most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation. CONCLUSIONS: By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice. Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/threats-validity-design-conduct-preclinical-efficacy-studies-systematic-review-guidelines-vivo-anima-10", "reader_count"=>127, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>6, "Librarian"=>2, "Researcher"=>32, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>23, "Student > Postgraduate"=>3, "Student > Master"=>24, "Other"=>7, "Student > Bachelor"=>13, "Lecturer"=>2, "Professor"=>7}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Professor > Associate Professor"=>6, "Librarian"=>2, "Researcher"=>32, "Student > Doctoral Student"=>5, "Student > Ph. D. Student"=>23, "Student > Postgraduate"=>3, "Student > Master"=>24, "Other"=>7, "Student > Bachelor"=>13, "Lecturer"=>2, "Professor"=>7}, "reader_count_by_subject_area"=>{"Unspecified"=>10, "Agricultural and Biological Sciences"=>38, "Arts and Humanities"=>1, "Philosophy"=>2, "Veterinary Science and Veterinary Medicine"=>3, "Business, Management and Accounting"=>1, "Chemical Engineering"=>1, "Chemistry"=>2, "Computer Science"=>1, "Engineering"=>5, "Environmental Science"=>2, "Biochemistry, Genetics and Molecular Biology"=>10, "Nursing and Health Professions"=>1, "Materials Science"=>1, "Medicine and Dentistry"=>33, "Neuroscience"=>4, "Pharmacology, Toxicology and Pharmaceutical Science"=>4, "Psychology"=>2, "Social Sciences"=>3, "Immunology and Microbiology"=>3}, "reader_count_by_subdiscipline"=>{"Materials Science"=>{"Materials Science"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>33}, "Social Sciences"=>{"Social Sciences"=>3}, "Psychology"=>{"Psychology"=>2}, "Unspecified"=>{"Unspecified"=>10}, "Environmental Science"=>{"Environmental Science"=>2}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>4}, "Chemical Engineering"=>{"Chemical Engineering"=>1}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Engineering"=>{"Engineering"=>5}, "Chemistry"=>{"Chemistry"=>2}, "Neuroscience"=>{"Neuroscience"=>4}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>3}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>38}, "Computer Science"=>{"Computer Science"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>10}, "Philosophy"=>{"Philosophy"=>2}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>3}}, "reader_count_by_country"=>{"Canada"=>3, "Netherlands"=>1, "Argentina"=>1, "Belgium"=>1, "United States"=>5, "Italy"=>2, "United Kingdom"=>2, "Malaysia"=>1, "Switzerland"=>1, "Germany"=>1}, "group_count"=>8}

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Scopus | Further Information

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/1128210"], "description"=>"<p>CV, threat to construct validity; EV, threat to external validity; IV, threat to internal validity; NINDS-NIH, US National Institutes of Health National Institute of Neurological Disorders and Stroke; PROG, research program recommendations.</p>", "links"=>[], "tags"=>["Clinical research design", "Animal models of disease", "Preclinical models", "Reporting guidelines", "Systematic reviews", "Drugs and devices", "Drug research and development", "drug discovery", "guidelines", "recommendations"], "article_id"=>752922, "categories"=>["Medicine"], "users"=>["Valerie C. Henderson", "Jonathan Kimmelman", "Dean Fergusson", "Jeremy M. Grimshaw", "Dan G. Hackam"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001489.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_To_what_extent_individual_guidelines_address_each_type_of_validity_threat_and_make_recommendations_regarding_the_overall_research_program_/752922", "title"=>"To what extent individual guidelines address each type of validity threat and make recommendations regarding the overall research program.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-23 09:23:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/1128211"], "description"=>"a<p>No unique guidelines that had not been previously identified through previous search strategies were found by searching the EQUATOR Network or through hand searching of references in identified guidelines.</p>b<p>The guidelines are listed under the search strategy by which they were first identified.</p>c<p>Guidelines that were grouped together during analysis (e.g., identical guidelines that were published in more than one journal).</p><p>NINDS-NIH, US National Institutes of Health National Institute of Neurological Disorders and Stroke.</p>", "links"=>[], "tags"=>["Clinical research design", "Animal models of disease", "Preclinical models", "Reporting guidelines", "Systematic reviews", "Drugs and devices", "Drug research and development", "drug discovery", "preclinical", "guidelines", "vivo", "experiments"], "article_id"=>752923, "categories"=>["Medicine"], "users"=>["Valerie C. Henderson", "Jonathan Kimmelman", "Dean Fergusson", "Jeremy M. Grimshaw", "Dan G. Hackam"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001489.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_preclinical_guidelines_for_in_vivo_experiments_identified_through_various_database_searches_/752923", "title"=>"Summary of preclinical guidelines for in vivo experiments identified through various database searches.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-23 09:23:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/1128212"], "description"=>"a<p>Explicit endorsement of STAIR <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001489#pmed.1001489-Fisher1\" target=\"_blank\">[10]</a>,<a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001489#pmed.1001489-1\" target=\"_blank\">[12]</a>.</p>b<p>Explicit endorsement Piper et al. <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001489#pmed.1001489-Piper1\" target=\"_blank\">[53]</a>.</p><p>CV, threat to construct validity; EV, threat to external validity; IV, threat to internal validity; O, outcome; PROG, research program recommendations; T, treatment; Ŧ, recommendation imported from an endorsed guideline but not otherwise stated in the endorsing guideline; U, units (animals); Δ, recommendation imported from an endorsed guideline and also explicitly stated in the endorsing guideline; Total, all parts of the experiment; X, recommendation explicitly stated in the guideline.</p><p>NINDS-NIH, US National Institutes of Health National Institute of Neurological Disorders and Stroke.</p>", "links"=>[], "tags"=>["Clinical research design", "Animal models of disease", "Preclinical models", "Reporting guidelines", "Systematic reviews", "Drugs and devices", "Drug research and development", "drug discovery", "extraction", "guidelines", "addressing", "threats", "preclinical"], "article_id"=>752924, "categories"=>["Medicine"], "users"=>["Valerie C. Henderson", "Jonathan Kimmelman", "Dean Fergusson", "Jeremy M. Grimshaw", "Dan G. Hackam"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0033417.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Results_of_recommendation_extraction_from_guidelines_addressing_validity_threats_in_preclinical_experiments_/752924", "title"=>"Results of recommendation extraction from guidelines addressing validity threats in preclinical experiments.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-23 09:23:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/1128213"], "description"=>"a<p>Recommendations concerning the coordination of experimental design practices across a program of research.</p>", "links"=>[], "tags"=>["Clinical research design", "Animal models of disease", "Preclinical models", "Reporting guidelines", "Systematic reviews", "Drugs and devices", "Drug research and development", "drug discovery", "recommendations", "preclinical", "guidelines", "vivo"], "article_id"=>752925, "categories"=>["Medicine"], "users"=>["Valerie C. Henderson", "Jonathan Kimmelman", "Dean Fergusson", "Jeremy M. Grimshaw", "Dan G. Hackam"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001489.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Most_frequent_recommendations_appearing_in_preclinical_research_guidelines_for_in_vivo_animal_experiments_/752925", "title"=>"Most frequent recommendations appearing in preclinical research guidelines for in vivo animal experiments.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-07-23 09:23:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/1128214", "https://ndownloader.figshare.com/files/1128220"], "description"=>"<div><p>Background</p><p>The vast majority of medical interventions introduced into clinical development prove unsafe or ineffective. One prominent explanation for the dismal success rate is flawed preclinical research. We conducted a systematic review of preclinical research guidelines and organized recommendations according to the type of validity threat (internal, construct, or external) or programmatic research activity they primarily address.</p><p>Methods and Findings</p><p>We searched MEDLINE, Google Scholar, Google, and the EQUATOR Network website for all preclinical guideline documents published up to April 9, 2013 that addressed the design and conduct of in vivo animal experiments aimed at supporting clinical translation. To be eligible, documents had to provide guidance on the design or execution of preclinical animal experiments and represent the aggregated consensus of four or more investigators. Data from included guidelines were independently extracted by two individuals for discrete recommendations on the design and implementation of preclinical efficacy studies. These recommendations were then organized according to the type of validity threat they addressed. A total of 2,029 citations were identified through our search strategy. From these, we identified 26 guidelines that met our eligibility criteria—most of which were directed at neurological or cerebrovascular drug development. Together, these guidelines offered 55 different recommendations. Some of the most common recommendations included performance of a power calculation to determine sample size, randomized treatment allocation, and characterization of disease phenotype in the animal model prior to experimentation.</p><p>Conclusions</p><p>By identifying the most recurrent recommendations among preclinical guidelines, we provide a starting point for developing preclinical guidelines in other disease domains. We also provide a basis for the study and evaluation of preclinical research practice.</p><p><i>Please see later in the article for the Editors' Summary</i></p></div>", "links"=>[], "tags"=>["Clinical research design", "Animal models of disease", "Preclinical models", "Reporting guidelines", "Systematic reviews", "Drugs and devices", "Drug research and development", "drug discovery", "preclinical", "efficacy", "systematic", "guidelines", "vivo"], "article_id"=>752926, "categories"=>["Medicine"], "users"=>["Valerie C. Henderson", "Jonathan Kimmelman", "Dean Fergusson", "Jeremy M. Grimshaw", "Dan G. Hackam"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001489.s001", "https://dx.doi.org/10.1371/journal.pmed.1001489.s002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Threats_to_Validity_in_the_Design_and_Conduct_of_Preclinical_Efficacy_Studies_A_Systematic_Review_of_Guidelines_for_In_Vivo_Animal_Experiments_/752926", "title"=>"Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2013-07-23 09:23:03"}

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Relative Metric

{"start_date"=>"2013-01-01T00:00:00Z", "end_date"=>"2013-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Medicine and health sciences", "average_usage"=>[264, 460, 584, 692, 794, 887, 978, 1067, 1154, 1241, 1328, 1408, 1474]}, {"subject_area"=>"/Medicine and health sciences/Health care", "average_usage"=>[278, 463, 587, 692, 804, 897, 984, 1068, 1165, 1254, 1339, 1429, 1490]}, {"subject_area"=>"/Medicine and health sciences/Pharmacology", "average_usage"=>[265, 471, 604, 723, 827, 926, 1022, 1113, 1210, 1290, 1377, 1454, 1532]}]}
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