cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.12848727.v2
title: An Otischalkian dinosauromorph assemblage from the Los Esteros Member (Santa Rosa Formation) of New Mexico and its implications for biochronology and lagerpetid body size

description: The strata of the American Southwest, particularly the Chinle Formation and the Dockum Group, are critical to our understanding of faunal diversity and evolution in the Late Triassic. In recent decades, these strata have informed the evolution of close dinosaur relatives, which remain poorly sampled and enigmatic in their geographic distribution. Here, we describe and discuss a new non-dinosaurian dinosauromorph assemblage from the Los Esteros Member of the Santa Rosa Formation at the base of the Dockum Group in east-central New Mexico. This assemblage includes hindlimb fragments assignable to Silesauridae and Lagerpetidae. Much of the lagerpetid material, assignable to <i>Dromomeron</i>, is of unusually large size. Based on a dataset of complete lagerpetid femora, we estimate a total femoral length of 221.9 mm for one partial femur, making it the largest reported individual. We also provide biochronological support that at least a portion of the Los Esteros Member corresponds to the Otischalkian land vertebrate faunachron through the identification of non-Mystriosuchinae phytosaurs. Subsequently, we question the presence of a bifurcated lateral ridge on the squamosal of all phytosaurs currently assigned to <i>Parasuchus</i>. This is the first Otischalkian fauna identified from New Mexico, and it reveals lagerpetids achieved large body size earlier than previously recognized. Our identifications expand the geographic and temporal range of non-dinosaurian dinosauromorphs in the American Southwest. The material presented here, in conjunction with an increasing number of <i>Dromomeron</i> specimens, demonstrates that non-dinosauriform dinosauromorphs could match or exceed the body size of many coeval dinosaurs.
DOI: 10.6084/m9.figshare.12848694.v1
title: A systematic review of the giant alligatoroid <i>Deinosuchus</i> from the Campanian of North America and its implications for the relationships at the root of Crocodylia

description: <i>Deinosuchus</i> is a lineage of giant (≥10 m) Late Cretaceous crocodylians from North America. These were the largest semiaquatic predators in their environments and are known to have fed on large vertebrates, including contemporaneous terrestrial vertebrates such as dinosaurs. Fossils have been found in units of Campanian age from northern Mexico to Montana in the west and Mississippi to New Jersey in the east. Three species have been named, and recent consensus suggests that they represent a single, widely ranging species. The authors studied newly collected material from western Texas and increased sampling from throughout North America to review species-level systematics of <i>Deinosuchus</i> and help refine its phylogenetic placement among crocodylians. <i>Deinosuchus</i> from eastern and western North America can be consistently differentiated and represent different species. A phylogenetic study is conducted including new character states. This work reinforces the identity of the ‘terror crocodile’ as an alligatoroid. Reference to the holotypes indicates that the generic name holder, <i>Deinosuchus hatcheri</i>, is extremely incomplete. As a result, the three known species of <i>Deinosuchus</i> cannot be differentiated. To ensure nomenclatural stability, the type species for <i>Deinosuchus</i> should be transferred to <i>Deinosuchus riograndensis</i>, a species known from multiple mostly complete individuals. Additionally, <i>Deinosuchus rugosus</i> is based on a holotype that is not diagnostic, and a new species, <i>Deinosuchus schwimmeri</i>, is named to encompass some specimens formerly assigned to <i>D. rugosus</i>.
DOI: 10.6084/m9.figshare.12848721.v1
title: <i>Norisdelphis annakaensis</i>, A new Miocene delphinid from Japan

description: Two well-preserved delphinid crania have been recovered from the Haraichi Formation, Annaka Group, Gunma Prefecture, Japan (earliest late Miocene, Tortonian; 11.29–11.25 Ma). The specimens represent a new genus and species of delphinid, <i>Norisdelphis annakaensis</i>. The new species is characterized by transversely narrow and anteroposteriorly elongated external bony nares, and a wider proximal extremity of the left premaxilla. Phylogenetic analysis suggests that <i>Norisdelphis</i> is the most basal member of the Delphinidae. The previous oldest known described delphinid, <i>Eodelphinus kabatensis</i>, is from the upper Miocene (ca. 9 Ma), and other reliably dated and described fossil delphinids are no older than Pliocene; thus, <i>N. annakaensis</i> is the oldest convincingly dated and well-diagnosed fossil delphinid species yet described. <i>Norisdelphis annakaensis</i> expands the geological range of the family Delphinidae.
DOI: 10.6084/m9.figshare.12848727
title: An Otischalkian dinosauromorph assemblage from the Los Esteros Member (Santa Rosa Formation) of New Mexico and its implications for biochronology and lagerpetid body size

description: The strata of the American Southwest, particularly the Chinle Formation and the Dockum Group, are critical to our understanding of faunal diversity and evolution in the Late Triassic. In recent decades, these strata have informed the evolution of close dinosaur relatives, which remain poorly sampled and enigmatic in their geographic distribution. Here, we describe and discuss a new non-dinosaurian dinosauromorph assemblage from the Los Esteros Member of the Santa Rosa Formation at the base of the Dockum Group in east-central New Mexico. This assemblage includes hindlimb fragments assignable to Silesauridae and Lagerpetidae. Much of the lagerpetid material, assignable to <i>Dromomeron</i>, is of unusually large size. Based on a dataset of complete lagerpetid femora, we estimate a total femoral length of 221.9 mm for one partial femur, making it the largest reported individual. We also provide biochronological support that at least a portion of the Los Esteros Member corresponds to the Otischalkian land vertebrate faunachron through the identification of non-Mystriosuchinae phytosaurs. Subsequently, we question the presence of a bifurcated lateral ridge on the squamosal of all phytosaurs currently assigned to <i>Parasuchus</i>. This is the first Otischalkian fauna identified from New Mexico, and it reveals lagerpetids achieved large body size earlier than previously recognized. Our identifications expand the geographic and temporal range of non-dinosaurian dinosauromorphs in the American Southwest. The material presented here, in conjunction with an increasing number of <i>Dromomeron</i> specimens, demonstrates that non-dinosauriform dinosauromorphs could match or exceed the body size of many coeval dinosaurs.
DOI: 10.6084/m9.figshare.12848709
title: Cryptoclidid plesiosaurs (Sauropterygia, Plesiosauria) from the Upper Jurassic of the Atacama Desert

description: This study presents the first plesiosaurs recovered from the Jurassic of the Atacama Desert that are informative at the genus level. One specimen is represented by an articulated axial section that shows distinctive features, such as cervical vertebrae with oval articular facets and gracile neural pedicles. The second specimen preserves similar vertebrae, teeth, propodials, and pectoral elements. Their anatomical characteristics allow us to refer them to <i>Muraenosaurus</i>, a genus of cryptoclidid plesiosaur previously reported in Callovian rocks of Europe and Argentina. A third specimen is represented by a fragmentary jaw, which coincides precisely in size and anatomical features with that of <i>Vinialesaurus caroli</i>, another cryptoclidid plesiosaur exclusively known from the Oxfordian of Cuba. The material studied represents the first record of <i>Muraenosaurus</i> in the Oxfordian of the Profeta-La Ternera Basin in northern Chile, adding to previous regional occurrences of the genus and to the record of <i>Cryptoclidus</i>, both also known from the Callovian of Argentina. On the other hand, the specimen referred to <i>Vinialesaurus</i> is the first appearance of this genus in the Southern Hemisphere. These new records give strong support to the exchange of marine vertebrates between the northern Tethys and the southern Pacific through the Caribbean Seaway during the Middle and Late Jurassic.
DOI: 10.6084/m9.figshare.12848727.v1
title: An Otischalkian dinosauromorph assemblage from the Los Esteros Member (Santa Rosa Formation) of New Mexico and its implications for biochronology and lagerpetid body size

description: The strata of the American Southwest, particularly the Chinle Formation and the Dockum Group, are critical to our understanding of faunal diversity and evolution in the Late Triassic. In recent decades, these strata have informed the evolution of close dinosaur relatives, which remain poorly sampled and enigmatic in their geographic distribution. Here, we describe and discuss a new non-dinosaurian dinosauromorph assemblage from the Los Esteros Member of the Santa Rosa Formation at the base of the Dockum Group in east-central New Mexico. This assemblage includes hindlimb fragments assignable to Silesauridae and Lagerpetidae. Much of the lagerpetid material, assignable to <i>Dromomeron</i>, is of unusually large size. Based on a dataset of complete lagerpetid femora, we estimate a total femoral length of 221.9 mm for one partial femur, making it the largest reported individual. We also provide biochronological support that at least a portion of the Los Esteros Member corresponds to the Otischalkian land vertebrate faunachron through the identification of non-Mystriosuchinae phytosaurs. Subsequently, we question the presence of a bifurcated lateral ridge on the squamosal of all phytosaurs currently assigned to <i>Parasuchus</i>. This is the first Otischalkian fauna identified from New Mexico, and it reveals lagerpetids achieved large body size earlier than previously recognized. Our identifications expand the geographic and temporal range of non-dinosaurian dinosauromorphs in the American Southwest. The material presented here, in conjunction with an increasing number of <i>Dromomeron</i> specimens, demonstrates that non-dinosauriform dinosauromorphs could match or exceed the body size of many coeval dinosaurs.
DOI: 10.6084/m9.figshare.12848709.v1
title: Cryptoclidid plesiosaurs (Sauropterygia, Plesiosauria) from the Upper Jurassic of the Atacama Desert

description: This study presents the first plesiosaurs recovered from the Jurassic of the Atacama Desert that are informative at the genus level. One specimen is represented by an articulated axial section that shows distinctive features, such as cervical vertebrae with oval articular facets and gracile neural pedicles. The second specimen preserves similar vertebrae, teeth, propodials, and pectoral elements. Their anatomical characteristics allow us to refer them to <i>Muraenosaurus</i>, a genus of cryptoclidid plesiosaur previously reported in Callovian rocks of Europe and Argentina. A third specimen is represented by a fragmentary jaw, which coincides precisely in size and anatomical features with that of <i>Vinialesaurus caroli</i>, another cryptoclidid plesiosaur exclusively known from the Oxfordian of Cuba. The material studied represents the first record of <i>Muraenosaurus</i> in the Oxfordian of the Profeta-La Ternera Basin in northern Chile, adding to previous regional occurrences of the genus and to the record of <i>Cryptoclidus</i>, both also known from the Callovian of Argentina. On the other hand, the specimen referred to <i>Vinialesaurus</i> is the first appearance of this genus in the Southern Hemisphere. These new records give strong support to the exchange of marine vertebrates between the northern Tethys and the southern Pacific through the Caribbean Seaway during the Middle and Late Jurassic.
DOI: 10.6084/m9.figshare.11868030.v1
title: Testing Procedures for Claiming Success on at Least <i>k</i> Out of <i>m</i> Hypotheses with an Application to Biosimilar Development

description: Multiplicity is a common issue in clinical drug development and there exists many proposals for the handling of multiple testing in clinical trials. However, the literature on testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests and the operating characteristics of these procedures is still sparse. Such testing is very relevant in biosimilar drug development, for example, where products have gained regulatory approval in the past, even though not all hypotheses could be rejected. Obviously, simple adjustments for multiplicity like the Bonferroni-adjustment or the Holm-procedure are valid as well for this testing problem, but can be conservative. In this article, we propose simple testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests which are more powerful than standard procedures while still providing strong control of the family-wise error rate. We illustrate their applicability in practice using an example from biosimilar drug development. In the supplementary materials, we provide proofs of the properties of our testing procedures and demonstrate the superiority of the proposed methodologies using simulations.
DOI: 10.6084/m9.figshare.11868030.v3
title: Testing Procedures for Claiming Success on at Least <i>k</i> Out of <i>m</i> Hypotheses with an Application to Biosimilar Development

description: Multiplicity is a common issue in clinical drug development and there exists many proposals for the handling of multiple testing in clinical trials. However, the literature on testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests and the operating characteristics of these procedures is still sparse. Such testing is very relevant in biosimilar drug development, for example, where products have gained regulatory approval in the past, even though not all hypotheses could be rejected. Obviously, simple adjustments for multiplicity like the Bonferroni-adjustment or the Holm-procedure are valid as well for this testing problem, but can be conservative. In this article, we propose simple testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests which are more powerful than standard procedures while still providing strong control of the family-wise error rate. We illustrate their applicability in practice using an example from biosimilar drug development. In the supplementary materials, we provide proofs of the properties of our testing procedures and demonstrate the superiority of the proposed methodologies using simulations.
DOI: 10.6084/m9.figshare.11734239
title: Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

description: The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.11734239.v3
title: Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

description: The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.11868030
title: Testing Procedures for Claiming Success on at Least <i>k</i> Out of <i>m</i> Hypotheses with an Application to Biosimilar Development

description: Multiplicity is a common issue in clinical drug development and there exists many proposals for the handling of multiple testing in clinical trials. However, the literature on testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests and the operating characteristics of these procedures is still sparse. Such testing is very relevant in biosimilar drug development, for example, where products have gained regulatory approval in the past, even though not all hypotheses could be rejected. Obviously, simple adjustments for multiplicity like the Bonferroni-adjustment or the Holm-procedure are valid as well for this testing problem, but can be conservative. In this article, we propose simple testing procedures for claiming success on at least <i>k</i> out of <i>m</i> tests which are more powerful than standard procedures while still providing strong control of the family-wise error rate. We illustrate their applicability in practice using an example from biosimilar drug development. In the supplementary materials, we provide proofs of the properties of our testing procedures and demonstrate the superiority of the proposed methodologies using simulations.
DOI: 10.6084/m9.figshare.11914380
title: The Use of a Variable Representing Compliance Improves Accuracy of Estimation of the Effect of Treatment Allocation Regardless of Discontinuation in Trials with Incomplete Follow-up

description: <i>Abstract–</i>In Clinical Trials, not all randomized patients follow the course of treatment they are allocated to. The potential impact of such deviations is increasingly recognized, and it has been one of the reasons for a redefinition of the targets of estimation (“Estimands”) in the ICH E9 draft Addendum. Among others, the effect of treatment assignment, regardless of the adherence, appears an Estimand of practical interest, in line with the intention-to-treat principle. This study aims at evaluating the performance of different estimation techniques in trials with incomplete post-discontinuation follow-up when a “treatment-policy” strategy is implemented. To achieve that, we have (i) modeled and visualized as directed acyclic diagram a reasonable data-generating model; (ii) investigated which set of variables allows identification and estimation of such effect; (iii) simulated 10,000 trials in Major Depressive Disorder, with varying real treatment effects, proportions of patients discontinuing the treatment, and incomplete follow-up. Our results suggest that, at least in a “Missing at Random” setting, all studied estimation methods increase their performance when a variable representing compliance is used. This effect is more pronounced the higher the proportion of post-discontinuation follow-up is.
DOI: 10.6084/m9.figshare.11914380.v2
title: The Use of a Variable Representing Compliance Improves Accuracy of Estimation of the Effect of Treatment Allocation Regardless of Discontinuation in Trials with Incomplete Follow-up

description: <i>Abstract–</i>In Clinical Trials, not all randomized patients follow the course of treatment they are allocated to. The potential impact of such deviations is increasingly recognized, and it has been one of the reasons for a redefinition of the targets of estimation (“Estimands”) in the ICH E9 draft Addendum. Among others, the effect of treatment assignment, regardless of the adherence, appears an Estimand of practical interest, in line with the intention-to-treat principle. This study aims at evaluating the performance of different estimation techniques in trials with incomplete post-discontinuation follow-up when a “treatment-policy” strategy is implemented. To achieve that, we have (i) modeled and visualized as directed acyclic diagram a reasonable data-generating model; (ii) investigated which set of variables allows identification and estimation of such effect; (iii) simulated 10,000 trials in Major Depressive Disorder, with varying real treatment effects, proportions of patients discontinuing the treatment, and incomplete follow-up. Our results suggest that, at least in a “Missing at Random” setting, all studied estimation methods increase their performance when a variable representing compliance is used. This effect is more pronounced the higher the proportion of post-discontinuation follow-up is.
DOI: 10.6084/m9.figshare.11734239.v2
title: Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

description: The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.
DOI: 10.6084/m9.figshare.11868030.v2
title: Testing procedures for claiming success on at least <i>k</i> out of <i>m</i> hypotheses with an application to biosimilar development

description: Multiplicity is a common issue in clinical drug development and there exists many proposals for the handling of multiple testing in clinical trials. However, the literature on testing procedures for claiming success on at least k out of m tests and the operating characteristics of these procedures is still sparse. Such testing is very relevant in biosimilar drug development, for example, where products have gained regulatory approval in the past, even though not all hypotheses could be rejected. Obviously, simple adjustments for multiplicity like the Bonferroni-adjustment or the Holm-procedure are valid as well for this testing problem, but can be conservative. In this paper, we propose simple testing procedures for claiming success on at least k out of m tests which are more powerful than standard procedures while still providing strong control of the family-wise error rate. We illustrate their applicability in practice using an example from biosimilar drug development. In the Supplementary Material we provide proofs of the properties of our testing procedures and demonstrate the superiority of the proposed methodologies using simulations.