Tumor Marker

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Douglas G Altman - One of the best experts on this subject based on the ideXlab platform.

  • reporting recommendations for Tumor Marker prognostic studies remark an abridged explanation and elaboration
    Journal of the National Cancer Institute, 2018
    Co-Authors: Willi Sauerbrei, Sheila E. Taube, Lisa M Mcshane, Margaret M Cavenagh, Douglas G Altman
    Abstract:

    The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) were developed to address widespread deficiencies in the reporting of such studies. The REMARK checklist consists of 20 items to report for published Tumor Marker prognostic studies. A detailed paper was published explaining the rationale behind checklist items, providing positive examples and giving empirical evidence of the quality of reporting. REMARK provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing Tumor Marker studies and prognostic studies in medicine in general. Despite support for REMARK from major cancer journals, prognostic factor research studies remain poorly reported. To encourage dissemination and uptake of REMARK, we have produced this considerably abridged version of the detailed explanatory manuscript, which may also serve as a brief guide to key issues for investigators planning Tumor Marker prognostic studies. To summarize the current situation, more recent papers investigating the quality of reporting and related reporting guidelines are cited, but otherwise the literature is not updated. Another important impetus for this paper is that it serves as a basis for literal translations into other languages. Translations will help to bring key information to a larger audience world-wide. Many more details can be found in the original paper.

  • reporting recommendations for Tumor Marker prognostic studies remark explanation and elaboration
    BMC Medicine, 2012
    Co-Authors: Douglas G Altman, Lisa M Mcshane, Willi Sauerbrei, Sheila E. Taube
    Abstract:

    Background The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published Tumor Marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

  • reporting recommendations for Tumor Marker prognostic studies remark
    Experimental Oncology, 2006
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often, initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same Marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute - European Organisation for Research and Treatment of Cancer (NCI - EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

  • reporting recommendations for Tumor Marker prognostic studies
    Journal of Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Lisa M. McShane, Biometric Research Branch, National Cancer Institute, Bethesda, MD Douglas G. Altman, Medical Statistics Group, Cancer Research UK, Centre for Statistics in Medicine, Wolfson College, Oxford, UK Willi Sauerbrei, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany Sheila E. Taube, Cancer Diagonisis Program, National Cancer Institute, Bethesda, MD Massimo Gion, Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy Gary M. Clark, OSI Pharmaceuticals Inc, Boulder, CO For the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics

  • reporting recommendations for Tumor Marker prognostic studies remark
    Nature Reviews Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons why multiple studies of the same Marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines provide helpful suggestions on how to present data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

Sheila E. Taube - One of the best experts on this subject based on the ideXlab platform.

  • reporting recommendations for Tumor Marker prognostic studies remark an abridged explanation and elaboration
    Journal of the National Cancer Institute, 2018
    Co-Authors: Willi Sauerbrei, Sheila E. Taube, Lisa M Mcshane, Margaret M Cavenagh, Douglas G Altman
    Abstract:

    The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) were developed to address widespread deficiencies in the reporting of such studies. The REMARK checklist consists of 20 items to report for published Tumor Marker prognostic studies. A detailed paper was published explaining the rationale behind checklist items, providing positive examples and giving empirical evidence of the quality of reporting. REMARK provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing Tumor Marker studies and prognostic studies in medicine in general. Despite support for REMARK from major cancer journals, prognostic factor research studies remain poorly reported. To encourage dissemination and uptake of REMARK, we have produced this considerably abridged version of the detailed explanatory manuscript, which may also serve as a brief guide to key issues for investigators planning Tumor Marker prognostic studies. To summarize the current situation, more recent papers investigating the quality of reporting and related reporting guidelines are cited, but otherwise the literature is not updated. Another important impetus for this paper is that it serves as a basis for literal translations into other languages. Translations will help to bring key information to a larger audience world-wide. Many more details can be found in the original paper.

  • reporting recommendations for Tumor Marker prognostic studies remark explanation and elaboration
    BMC Medicine, 2012
    Co-Authors: Douglas G Altman, Lisa M Mcshane, Willi Sauerbrei, Sheila E. Taube
    Abstract:

    Background The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published Tumor Marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

  • reporting recommendations for Tumor Marker prognostic studies remark
    Experimental Oncology, 2006
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often, initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same Marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute - European Organisation for Research and Treatment of Cancer (NCI - EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

  • reporting recommendations for Tumor Marker prognostic studies
    Journal of Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Lisa M. McShane, Biometric Research Branch, National Cancer Institute, Bethesda, MD Douglas G. Altman, Medical Statistics Group, Cancer Research UK, Centre for Statistics in Medicine, Wolfson College, Oxford, UK Willi Sauerbrei, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany Sheila E. Taube, Cancer Diagonisis Program, National Cancer Institute, Bethesda, MD Massimo Gion, Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy Gary M. Clark, OSI Pharmaceuticals Inc, Boulder, CO For the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics

  • reporting recommendations for Tumor Marker prognostic studies remark
    Nature Reviews Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons why multiple studies of the same Marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines provide helpful suggestions on how to present data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

Lisa M Mcshane - One of the best experts on this subject based on the ideXlab platform.

  • reporting recommendations for Tumor Marker prognostic studies remark an abridged explanation and elaboration
    Journal of the National Cancer Institute, 2018
    Co-Authors: Willi Sauerbrei, Sheila E. Taube, Lisa M Mcshane, Margaret M Cavenagh, Douglas G Altman
    Abstract:

    The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) were developed to address widespread deficiencies in the reporting of such studies. The REMARK checklist consists of 20 items to report for published Tumor Marker prognostic studies. A detailed paper was published explaining the rationale behind checklist items, providing positive examples and giving empirical evidence of the quality of reporting. REMARK provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing Tumor Marker studies and prognostic studies in medicine in general. Despite support for REMARK from major cancer journals, prognostic factor research studies remain poorly reported. To encourage dissemination and uptake of REMARK, we have produced this considerably abridged version of the detailed explanatory manuscript, which may also serve as a brief guide to key issues for investigators planning Tumor Marker prognostic studies. To summarize the current situation, more recent papers investigating the quality of reporting and related reporting guidelines are cited, but otherwise the literature is not updated. Another important impetus for this paper is that it serves as a basis for literal translations into other languages. Translations will help to bring key information to a larger audience world-wide. Many more details can be found in the original paper.

  • publication of Tumor Marker research results the necessity for complete and transparent reporting
    Journal of Clinical Oncology, 2012
    Co-Authors: Lisa M Mcshane, Daniel F. Hayes
    Abstract:

    Clinical management decisions for patients with cancer are increasingly being guided by prognostic and predictive Markers. Use of these Markers should be based on a sufficiently comprehensive body of unbiased evidence to establish that benefits to patients outweigh harms and to justify expenditure of health care dollars. Careful assessments of the clinical utility of Markers by using comparative effectiveness research methods are urgently needed to more rigorously summarize and evaluate the evidence, but multiple factors have made such assessments difficult. The literature on Tumor Markers is plagued by nonpublication bias, selective reporting, and incomplete reporting. Several measures to address these problems are discussed, including development of a Tumor Marker study registry, greater attention to assay analytic performance and specimen quality, use of more rigorous study designs and analysis plans to establish clinical utility, and adherence to higher standards for reporting Tumor Marker studies. Mo...

  • reporting recommendations for Tumor Marker prognostic studies remark explanation and elaboration
    BMC Medicine, 2012
    Co-Authors: Douglas G Altman, Lisa M Mcshane, Willi Sauerbrei, Sheila E. Taube
    Abstract:

    Background The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published Tumor Marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

  • reporting recommendations for Tumor Marker prognostic studies remark
    Experimental Oncology, 2006
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often, initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same Marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute - European Organisation for Research and Treatment of Cancer (NCI - EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

  • reporting recommendations for Tumor Marker prognostic studies
    Journal of Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Lisa M. McShane, Biometric Research Branch, National Cancer Institute, Bethesda, MD Douglas G. Altman, Medical Statistics Group, Cancer Research UK, Centre for Statistics in Medicine, Wolfson College, Oxford, UK Willi Sauerbrei, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany Sheila E. Taube, Cancer Diagonisis Program, National Cancer Institute, Bethesda, MD Massimo Gion, Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy Gary M. Clark, OSI Pharmaceuticals Inc, Boulder, CO For the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics

Willi Sauerbrei - One of the best experts on this subject based on the ideXlab platform.

  • reporting recommendations for Tumor Marker prognostic studies remark an abridged explanation and elaboration
    Journal of the National Cancer Institute, 2018
    Co-Authors: Willi Sauerbrei, Sheila E. Taube, Lisa M Mcshane, Margaret M Cavenagh, Douglas G Altman
    Abstract:

    The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) were developed to address widespread deficiencies in the reporting of such studies. The REMARK checklist consists of 20 items to report for published Tumor Marker prognostic studies. A detailed paper was published explaining the rationale behind checklist items, providing positive examples and giving empirical evidence of the quality of reporting. REMARK provides a comprehensive overview to educate on good reporting and provide a valuable reference for the many issues to consider when designing, conducting, and analyzing Tumor Marker studies and prognostic studies in medicine in general. Despite support for REMARK from major cancer journals, prognostic factor research studies remain poorly reported. To encourage dissemination and uptake of REMARK, we have produced this considerably abridged version of the detailed explanatory manuscript, which may also serve as a brief guide to key issues for investigators planning Tumor Marker prognostic studies. To summarize the current situation, more recent papers investigating the quality of reporting and related reporting guidelines are cited, but otherwise the literature is not updated. Another important impetus for this paper is that it serves as a basis for literal translations into other languages. Translations will help to bring key information to a larger audience world-wide. Many more details can be found in the original paper.

  • reporting recommendations for Tumor Marker prognostic studies remark explanation and elaboration
    BMC Medicine, 2012
    Co-Authors: Douglas G Altman, Lisa M Mcshane, Willi Sauerbrei, Sheila E. Taube
    Abstract:

    Background The Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK) checklist consists of 20 items to report for published Tumor Marker prognostic studies. It was developed to address widespread deficiencies in the reporting of such studies. In this paper we expand on the REMARK checklist to enhance its use and effectiveness through better understanding of the intent of each item and why the information is important to report.

  • reporting recommendations for Tumor Marker prognostic studies remark
    Experimental Oncology, 2006
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often, initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same Marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute - European Organisation for Research and Treatment of Cancer (NCI - EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

  • reporting recommendations for Tumor Marker prognostic studies
    Journal of Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Lisa M. McShane, Biometric Research Branch, National Cancer Institute, Bethesda, MD Douglas G. Altman, Medical Statistics Group, Cancer Research UK, Centre for Statistics in Medicine, Wolfson College, Oxford, UK Willi Sauerbrei, Institut fuer Medizinische Biometrie und Medizinische Informatik, Universitaetsklinikum Freiburg, Freiburg, Germany Sheila E. Taube, Cancer Diagonisis Program, National Cancer Institute, Bethesda, MD Massimo Gion, Centro Regionale Indicatori Biochimici di Tumore, Ospedale Civile, Venezia, Italy Gary M. Clark, OSI Pharmaceuticals Inc, Boulder, CO For the Statistics Subcommittee of the NCI-EORTC Working Group on Cancer Diagnostics

  • reporting recommendations for Tumor Marker prognostic studies remark
    Nature Reviews Clinical Oncology, 2005
    Co-Authors: Lisa M Mcshane, Sheila E. Taube, Douglas G Altman, Willi Sauerbrei, Massimo Gion, Gary M Clark
    Abstract:

    Despite years of research and hundreds of reports on Tumor Markers in oncology, the number of Markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a Marker show great promise, but subsequent studies on the same or related Markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons why multiple studies of the same Marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many Tumor Marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of Tumor Marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines provide helpful suggestions on how to present data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

Dorte Nielsen - One of the best experts on this subject based on the ideXlab platform.

  • computer simulated Tumor Marker data used to compare progression criteria for cytokeratin tissue polypeptide antigen in metastatic breast cancer
    Clinical Chemistry, 2001
    Co-Authors: Gyorgy Soletormos, Per Hyltoft Petersen, Dorte Nielsen
    Abstract:

    Clinical trials have suggested that the serologic cytokeratin Tumor Marker tissue polypeptide antigen (TPA) may be important as a monitor of metastatic breast cancer (1)(2)(3). The usefulness of this Marker depends on the ability to identify, predict, and exclude Tumor growth before the changes are detectable by imaging techniques and routine biochemistry (4)(5)(6). It is, however, difficult to compare results because the investigated patient populations have been heterogeneous. It remains unknown how TPA assessment criteria perform in situations with different ( a ) time intervals between measurements, ( b ) numbers of measurements, ( c ) rates of increase during progression, and ( d ) analytical quality. The time and expense required to investigate these issues in new studies will be considerable. Recently, computer-simulated Marker data have been suggested to compare the diagnostic accuracy of assessment criteria used to interpret longitudinal cancer antigen (CA) 15.3 and carcinoembryonic antigen (CEA) data (7)(8). The computer-based approach was useful because the descriptive variables described above could be standardized and changed individually according to the simulated clinical and laboratory situation. The procedure-identified criteria must have a high ability to detect early CA 15.3 and CEA progression and at the same time maintain robustness against false-positive signals. Because TPA measurements among patients are frequently performed in combination with CA 15.3 and CEA, we consider it relevant to investigate whether computer-simulated data can be used to identify reliable criteria to interpret sequential TPA concentrations. However, because the typical background variability of TPA and the rate of TPA increase during progression are different as compared with CA 15.3 and CEA (7), we generated new data sets in the present simulation procedure to test our …