The Experts below are selected from a list of 6405 Experts worldwide ranked by ideXlab platform

Emily S Sena - One of the best experts on this subject based on the ideXlab platform.

  • reprint Good Laboratory Practice preventing introduction of bias at the bench
    Journal of Cerebral Blood Flow and Metabolism, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman
    Abstract:

    As a research community, we have failed to show that drugs, which show substantial efficacy in animal models of cerebral ischemia, can also improve outcome in human stroke. Accumulating evidence suggests this may be due, at least in part, to problems in the design, conduct, and reporting of animal experiments which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • Good Laboratory Practice preventing introduction of bias at the bench
    Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan
    Abstract:

    Background and Purpose—As a research community, we have failed to demonstrate that drugs which show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Summary of Review—Accumulating evidence suggests this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Conclusions—Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • reprint Good Laboratory Practice preventing introduction of bias at the bench
    International Journal of Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman
    Abstract:

    As a research community, we have failed to demonstrate that drugs that show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Accumulating evidence suggests that this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments, which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • Good Laboratory Practice preventing introduction of bias at the bench reprinted
    International Journal of Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan
    Abstract:

    As a research community, we have failed to demonstrate that drugs that show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Accumulating evidence suggests that this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments, which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • comments opinions and reviews Good Laboratory Practice preventing introduction of bias at the bench
    2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman, Kazuo Minematsu, Geoffrey A Donnan
    Abstract:

    efficacy. Conclusions—Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke. (Stroke. 2009;40:e50-e52.)

Charles W Schmidt - One of the best experts on this subject based on the ideXlab platform.

  • judging the data peer review versus Good Laboratory Practice standards
    Environmental Health Perspectives, 2012
    Co-Authors: Charles W Schmidt
    Abstract:

    When it comes to assessing the quality of toxicologic data to develop policy decisions, should regulators rely on journal peer review or on Good Laboratory Practice (GLP) standards? Authors of a review comparing the two conclude that the answer is neither. Instead, they propose that regulators need a well-defined scheme in which the best elements of both processes enable data to be weighed and evaluated in a consistent fashion [EHP 120(7):927–934; McCarty et al.]. The authors point out that peer review and GLP standards serve different but complementary needs. Traditional peer review aims to supply scientists with published articles worthy of consideration and debate; GLP standards—which are specific protocols for conducting and reporting experiments—aim to provide regulators with high-quality data that are acceptable across jurisdictions. The authors go on to expose the shortcomings of each framework for policy use. According to their analysis, peer review suffers from reviewer bias, inconsistency in methods between journals, variable ability to identify fraud or falsified data, and a reluctance to publish results that show little or no effects. GLP standards, on the other hand, don’t address broad issues of scientific validity, although they supply consensual formats for gathering and analyzing data. But instead of arguing over which of the two approaches best suits policy making, the authors propose that stakeholders should focus instead on the approaches’ growing convergence. That convergence, they propose, comes mainly from the peer-review side, which increasingly requires additional data reporting and supplementary methodological information for online publication—a trend they say serves public needs for data transparency and better communication of scientific concepts. But what regulators in toxicology need above all else, the authors emphasize, is reliable, adequate, relevant data. Toward that end, the authors propose a weight-of-evidence scheme for data evaluation that comprises six steps: 1) Define the uses and goals of the regulatory action, and identify testable hypotheses; 2) define priorities for data weighting and support them with references; 3) gather the relevant data in a systematic way; 4) evaluate how well each selected study fulfilled its initial intent; 5) combine all data weightings in a predefined manner to achieve a score for each study; and 6) integrate the scores into a narrative that addresses judgments and conclusions derived from the entire evaluation process. Although neither peer review nor GLP standards can fully meet the needs for data quality and relevant science on their own, the authors write, a properly devised weight-of-evidence scheme can fill those overarching requirements.

Ellen Mihaich - One of the best experts on this subject based on the ideXlab platform.

  • information quality in regulatory decision making peer review versus Good Laboratory Practice
    Environmental Health Perspectives, 2012
    Co-Authors: Lynn S Mccarty, Christopher J Borgert, Ellen Mihaich
    Abstract:

    Background: There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Discussion: Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Conclusions: Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

Kathryn G Schuff - One of the best experts on this subject based on the ideXlab platform.

  • a roadmap for academic health centers to establish Good Laboratory Practice compliant infrastructure
    Academic Medicine, 2012
    Co-Authors: Joan E Adamo, Gerhard Bauer, Marlene Berro, Bruce K Burnett, Karen A Hartman, Lisa M Masiello, Diane Moormanwhite, Eric P Rubinstein, Kathryn G Schuff
    Abstract:

    Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by Good Laboratory Practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.

  • A Roadmap for Academic Health Centers to Establish Good Laboratory Practice–Compliant Infrastructure
    Academic Medicine, 2012
    Co-Authors: Joan E Adamo, Gerhard Bauer, Marlene Berro, Bruce K Burnett, Karen A Hartman, Lisa M Masiello, Eric P Rubinstein, Diane Moorman-white, Kathryn G Schuff
    Abstract:

    Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by Good Laboratory Practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.

Alistair Buchan - One of the best experts on this subject based on the ideXlab platform.

  • reprint Good Laboratory Practice preventing introduction of bias at the bench
    Journal of Cerebral Blood Flow and Metabolism, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman
    Abstract:

    As a research community, we have failed to show that drugs, which show substantial efficacy in animal models of cerebral ischemia, can also improve outcome in human stroke. Accumulating evidence suggests this may be due, at least in part, to problems in the design, conduct, and reporting of animal experiments which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • Good Laboratory Practice preventing introduction of bias at the bench
    Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan
    Abstract:

    Background and Purpose—As a research community, we have failed to demonstrate that drugs which show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Summary of Review—Accumulating evidence suggests this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Conclusions—Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • reprint Good Laboratory Practice preventing introduction of bias at the bench
    International Journal of Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman
    Abstract:

    As a research community, we have failed to demonstrate that drugs that show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Accumulating evidence suggests that this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments, which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • Good Laboratory Practice preventing introduction of bias at the bench reprinted
    International Journal of Stroke, 2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Philip M W Bath, Alistair Buchan
    Abstract:

    As a research community, we have failed to demonstrate that drugs that show substantial efficacy in animal models of cerebral ischemia can also improve outcome in human stroke. Accumulating evidence suggests that this may be due, at least in part, to problems in the design, conduct and reporting of animal experiments, which create a systematic bias resulting in the overstatement of neuroprotective efficacy. Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke.

  • comments opinions and reviews Good Laboratory Practice preventing introduction of bias at the bench
    2009
    Co-Authors: Malcolm R Macleod, Marc Fisher, Victoria Ocollins, Emily S Sena, Ulrich Dirnagl, Alistair Buchan, Bart H Van Der Worp, Richard J Traystman, Kazuo Minematsu, Geoffrey A Donnan
    Abstract:

    efficacy. Conclusions—Here, we set out a series of measures to reduce bias in the design, conduct and reporting of animal experiments modeling human stroke. (Stroke. 2009;40:e50-e52.)