�ݺ�ߣshows by User: tinazzia

�ݺ�ߣshows by User: tinazzia / http://www.slideshare.net/images/logo.gif �ݺ�ߣshows by User: tinazzia / Sat, 09 May 2015 06:05:05 GMT �ݺ�ߣShare feed for �ݺ�ߣshows by User: tinazzia Adapting CDISC to Adaptive Design /slideshow/adapting-cdisc-to-adaptive-design/47935255 cdiscbasel2015atinazziadaptivedesigns-150509060505-lva1-app6891
The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.]]>
The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.]]> Sat, 09 May 2015 06:05:05 GMT /slideshow/adapting-cdisc-to-adaptive-design/47935255 tinazzia@slideshare.net(tinazzia) Adapting CDISC to Adaptive Design tinazzia The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cdiscbasel2015atinazziadaptivedesigns-150509060505-lva1-app6891-thumbnail.jpg?width=120&height=120&fit=bounds" /> The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.

Adapting CDISC to Adaptive Design from Angelo Tinazzi

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0 Adapting to Adaptive /slideshow/adapting-to-adaptive/46558820 pp08final-150401192347-conversion-gate01
The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.]]>
The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.]]> Wed, 01 Apr 2015 19:23:47 GMT /slideshow/adapting-to-adaptive/46558820 tinazzia@slideshare.net(tinazzia) Adapting to Adaptive tinazzia The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/pp08final-150401192347-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> The use of Adaptive designs is becoming quite popular and well-perceived by the regulatory agencies such as the FDA in the US. “Adaptation” can occur in different fashion and potentially make studies more efficient (e.g. shorter duration, fewer patients) more likely to demonstrate an effect of the drug if one exists, or more informative (see “Adaptive Design Clinical Trials for Drugs and Biologics” FDA guidance). The aim of this presentation is to illustrate a case where an adaptive design was used in a Phase III oncology pivotal study having Overall Survival as a primary end-point. The particular adaptation implemented was an un-blinded SSR that applied a promising zone approach. The main focus will be how the adaptive design impacted the SDTM modelling, the design of some ADaM datasets (e.g. those containing the time-to-event endpoints and therefore using ADTTE ADaM model) and later on how some mapping and analysis decisions were described in both the study and analysis reviewer guide.

Adapting to Adaptive from Angelo Tinazzi

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0 CDISC SDTM and ADaM for survival data /slideshow/cdisc-sdtm-and-adam-for-survival-data/41025710 biasgenoa201410atinazzi-141102154547-conversion-gate02
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CDISC SDTM and ADaM for survival data from Angelo Tinazzi

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0 Looking for SDTM �migration specialist /slideshow/cd13/40623801 cd13-141023004654-conversion-gate02
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]]> Thu, 23 Oct 2014 00:46:54 GMT /slideshow/cd13/40623801 tinazzia@slideshare.net(tinazzia) Looking for SDTM �migration specialist tinazzia <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cd13-141023004654-conversion-gate02-thumbnail.jpg?width=120&height=120&fit=bounds" />

Looking for SDTM migration specialist from Angelo Tinazzi

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0 A Systematic Review of ADaM IG Interpretation /slideshow/a-systematic-review-of-adam-ig-interpretation/40623753 cdiscparis2014atinazziadam-141023004448-conversion-gate01
Tips and ]]>
Tips and ]]> Thu, 23 Oct 2014 00:44:48 GMT /slideshow/a-systematic-review-of-adam-ig-interpretation/40623753 tinazzia@slideshare.net(tinazzia) A Systematic Review of ADaM IG Interpretation tinazzia Tips and <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cdiscparis2014atinazziadam-141023004448-conversion-gate01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Tips and

A Systematic Review of ADaM IG Interpretation from Angelo Tinazzi

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0 Looking for SDTM �migration specialist /slideshow/looking-for-sdtm-migration-specialist/40623615 cd13-141023003832-conversion-gate02
Experience in migrating legacy study to CDISC SDTM]]>
Experience in migrating legacy study to CDISC SDTM]]> Thu, 23 Oct 2014 00:38:32 GMT /slideshow/looking-for-sdtm-migration-specialist/40623615 tinazzia@slideshare.net(tinazzia) Looking for SDTM �migration specialist tinazzia Experience in migrating legacy study to CDISC SDTM <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cd13-141023003832-conversion-gate02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Experience in migrating legacy study to CDISC SDTM

Looking for SDTM migration specialist from Angelo Tinazzi

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0 Therapeutic Area Standards –�Reflections on Oncology standards and what is needed in the future /slideshow/cdisc-paris-2014atinazzioncology/40623510 cdiscparis2014atinazzioncology-141023003404-conversion-gate02
CDISC Therapuetica Area Panelit Discussion at CDISC Europe Interchange in Paris - April 2014]]>
CDISC Therapuetica Area Panelit Discussion at CDISC Europe Interchange in Paris - April 2014]]> Thu, 23 Oct 2014 00:34:03 GMT /slideshow/cdisc-paris-2014atinazzioncology/40623510 tinazzia@slideshare.net(tinazzia) Therapeutic Area Standards –�Reflections on Oncology standards and what is needed in the future tinazzia CDISC Therapuetica Area Panelit Discussion at CDISC Europe Interchange in Paris - April 2014 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cdiscparis2014atinazzioncology-141023003404-conversion-gate02-thumbnail.jpg?width=120&height=120&fit=bounds" /> CDISC Therapuetica Area Panelit Discussion at CDISC Europe Interchange in Paris - April 2014

Therapeutic Area Standards – Reflections on Oncology standards and what is needed in the future from Angelo Tinazzi

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0 The PhUSE Therapeutic Area Wiki Page /slideshow/ph-use-csstawiki/32440797 phusecsstawiki-140318065653-phpapp02
While the evolution of information technology is bringing the data closer to customers for their own exploration, the need of a comprehensive understanding of the therapeutic area knowledge for programmers in clinical development is increasing. Starting with a basic understanding on the medical background, special assessment methods, ways of statistically analyzing and displaying the data, to name a few essential ones enables programmers to interact with partners (e.g. scientist, statisticians etc.) on equal par. In this intent, activities to collect and provide comprehensive information around the Oncology and Rheumatoid Arthritis Therapeutic Areas (TA) via the PhUSE Wiki had started in February 2013 and continued throughout the year. Various PhUSE members have spent time and energy to provide and expand their knowledge and make it available to the entire community. Today, although there is still much to do to complete and maintain the collected material, the two TA Wikis are a useful tool for Statistical Programmers approaching these TA for the first time or who want to improve their knowledge. Moreover the PhUSE Wiki can be seen as a basic tool for future developments to improve the way professionals in the different TA work. An established working relationship across organizations, pharmaceutical companies or external service providers, will help to support implementation of TA-specific standards from mapping raw data in SDTM, data analysis using ADaM and finally data presentation in standardized outputs. The PhUSE Wiki can be the central place to share important updates such as new CDISC TA standards or the availability of new TA regulatory guidance. On the other hand we see the Wiki as a place to discuss, to stimulate and inspire new initiatives among the “SAS-Programming Community”, be it Statisticians, Programmers, Data Managers or everyone else involved; this may include specific TA working related white papers and/or scripts being part of the FDA Working Groups WG5 “Development of Standard Scripts for Analysis and Programming” Project 08 “Create white papers providing recommended display and analysis including Table, List and Figure shells”. Presented at PhUSE/FDA CSS 2014 in Silver Spring (US) ]]>
While the evolution of information technology is bringing the data closer to customers for their own exploration, the need of a comprehensive understanding of the therapeutic area knowledge for programmers in clinical development is increasing. Starting with a basic understanding on the medical background, special assessment methods, ways of statistically analyzing and displaying the data, to name a few essential ones enables programmers to interact with partners (e.g. scientist, statisticians etc.) on equal par. In this intent, activities to collect and provide comprehensive information around the Oncology and Rheumatoid Arthritis Therapeutic Areas (TA) via the PhUSE Wiki had started in February 2013 and continued throughout the year. Various PhUSE members have spent time and energy to provide and expand their knowledge and make it available to the entire community. Today, although there is still much to do to complete and maintain the collected material, the two TA Wikis are a useful tool for Statistical Programmers approaching these TA for the first time or who want to improve their knowledge. Moreover the PhUSE Wiki can be seen as a basic tool for future developments to improve the way professionals in the different TA work. An established working relationship across organizations, pharmaceutical companies or external service providers, will help to support implementation of TA-specific standards from mapping raw data in SDTM, data analysis using ADaM and finally data presentation in standardized outputs. The PhUSE Wiki can be the central place to share important updates such as new CDISC TA standards or the availability of new TA regulatory guidance. On the other hand we see the Wiki as a place to discuss, to stimulate and inspire new initiatives among the “SAS-Programming Community”, be it Statisticians, Programmers, Data Managers or everyone else involved; this may include specific TA working related white papers and/or scripts being part of the FDA Working Groups WG5 “Development of Standard Scripts for Analysis and Programming” Project 08 “Create white papers providing recommended display and analysis including Table, List and Figure shells”. Presented at PhUSE/FDA CSS 2014 in Silver Spring (US) ]]> Tue, 18 Mar 2014 06:56:53 GMT /slideshow/ph-use-csstawiki/32440797 tinazzia@slideshare.net(tinazzia) The PhUSE Therapeutic Area Wiki Page tinazzia While the evolution of information technology is bringing the data closer to customers for their own exploration, the need of a comprehensive understanding of the therapeutic area knowledge for programmers in clinical development is increasing. Starting with a basic understanding on the medical background, special assessment methods, ways of statistically analyzing and displaying the data, to name a few essential ones enables programmers to interact with partners (e.g. scientist, statisticians etc.) on equal par. In this intent, activities to collect and provide comprehensive information around the Oncology and Rheumatoid Arthritis Therapeutic Areas (TA) via the PhUSE Wiki had started in February 2013 and continued throughout the year. Various PhUSE members have spent time and energy to provide and expand their knowledge and make it available to the entire community. Today, although there is still much to do to complete and maintain the collected material, the two TA Wikis are a useful tool for Statistical Programmers approaching these TA for the first time or who want to improve their knowledge. Moreover the PhUSE Wiki can be seen as a basic tool for future developments to improve the way professionals in the different TA work. An established working relationship across organizations, pharmaceutical companies or external service providers, will help to support implementation of TA-specific standards from mapping raw data in SDTM, data analysis using ADaM and finally data presentation in standardized outputs. The PhUSE Wiki can be the central place to share important updates such as new CDISC TA standards or the availability of new TA regulatory guidance. On the other hand we see the Wiki as a place to discuss, to stimulate and inspire new initiatives among the “SAS-Programming Community”, be it Statisticians, Programmers, Data Managers or everyone else involved; this may include specific TA working related white papers and/or scripts being part of the FDA Working Groups WG5 “Development of Standard Scripts for Analysis and Programming” Project 08 “Create white papers providing recommended display and analysis including Table, List and Figure shells”. Presented at PhUSE/FDA CSS 2014 in Silver Spring (US) <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/phusecsstawiki-140318065653-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> While the evolution of information technology is bringing the data closer to customers for their own exploration, the need of a comprehensive understanding of the therapeutic area knowledge for programmers in clinical development is increasing. Starting with a basic understanding on the medical background, special assessment methods, ways of statistically analyzing and displaying the data, to name a few essential ones enables programmers to interact with partners (e.g. scientist, statisticians etc.) on equal par. In this intent, activities to collect and provide comprehensive information around the Oncology and Rheumatoid Arthritis Therapeutic Areas (TA) via the PhUSE Wiki had started in February 2013 and continued throughout the year. Various PhUSE members have spent time and energy to provide and expand their knowledge and make it available to the entire community. Today, although there is still much to do to complete and maintain the collected material, the two TA Wikis are a useful tool for Statistical Programmers approaching these TA for the first time or who want to improve their knowledge. Moreover the PhUSE Wiki can be seen as a basic tool for future developments to improve the way professionals in the different TA work. An established working relationship across organizations, pharmaceutical companies or external service providers, will help to support implementation of TA-specific standards from mapping raw data in SDTM, data analysis using ADaM and finally data presentation in standardized outputs. The PhUSE Wiki can be the central place to share important updates such as new CDISC TA standards or the availability of new TA regulatory guidance. On the other hand we see the Wiki as a place to discuss, to stimulate and inspire new initiatives among the “SAS-Programming Community”, be it Statisticians, Programmers, Data Managers or everyone else involved; this may include specific TA working related white papers and/or scripts being part of the FDA Working Groups WG5 “Development of Standard Scripts for Analysis and Programming” Project 08 “Create white papers providing recommended display and analysis including Table, List and Figure shells”. Presented at PhUSE/FDA CSS 2014 in Silver Spring (US)

The PhUSE Therapeutic Area Wiki Page from Angelo Tinazzi

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0 Interpreting CDISC ADaM IG through Users Interpretation /slideshow/interpreting-cdisc-adam-ig-through-users-interpretation/32440747 cd01-140318065524-phpapp02
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Interpreting CDISC ADaM IG through Users Interpretation from Angelo Tinazzi

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0 Efficacy endpoints in Oncology /slideshow/efficacy-endpoints-in-oncology/32433996 is01-140318033122-phpapp01
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Efficacy endpoints in Oncology from Angelo Tinazzi

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0 A gentle introduction to survival analysis /slideshow/a-gentle-introduction-to-survival-analysis/32403091 st03-140317102040-phpapp02
Presennted at PhUSE 2008]]>
Presennted at PhUSE 2008]]> Mon, 17 Mar 2014 10:20:40 GMT /slideshow/a-gentle-introduction-to-survival-analysis/32403091 tinazzia@slideshare.net(tinazzia) A gentle introduction to survival analysis tinazzia Presennted at PhUSE 2008 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/st03-140317102040-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presennted at PhUSE 2008

A gentle introduction to survival analysis from Angelo Tinazzi

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0 A gentle introduction to meta-analysis /slideshow/tu03/32403023 tu03-140317101918-phpapp01
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]]> Mon, 17 Mar 2014 10:19:18 GMT /slideshow/tu03/32403023 tinazzia@slideshare.net(tinazzia) A gentle introduction to meta-analysis tinazzia <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/tu03-140317101918-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" />

A gentle introduction to meta-analysis from Angelo Tinazzi

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0 SDTM modelling: from study protocol to SDTM-compliant datasets /slideshow/sdtm-modelling-from-study-protocol-to-sdtmcompliant-datasets/32376091 biasmilan201403atinazzi-140316165133-phpapp02
Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute – Milano - 14/03/2014 ]]>
Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute – Milano - 14/03/2014 ]]> Sun, 16 Mar 2014 16:51:33 GMT /slideshow/sdtm-modelling-from-study-protocol-to-sdtmcompliant-datasets/32376091 tinazzia@slideshare.net(tinazzia) SDTM modelling: from study protocol to SDTM-compliant datasets tinazzia Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute – Milano - 14/03/2014 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/biasmilan201403atinazzi-140316165133-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Biometristi Italiani Associati – Seminario BIAS CDISC SDTM and ADaM: Moving from theory to practice SAS Institute – Milano - 14/03/2014

SDTM modelling: from study protocol to SDTM-compliant datasets from Angelo Tinazzi

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0 CLINICAL STUDY REPORT - IN-TEXT TABLES, TABLES FIGURES AND GRAPHS, PATIENT AND INDIVIDUAL PATIENT DATA LISTINGS: ICH E3 TECHNICAL REQUISITES AND POSSIBLE SOLUTION IN SAS /slideshow/sas-conf-milan201302atinazzi/27570843 sasconfmilan201302atinazzi-131025101140-phpapp01
Presented at BIAS "Data handling and reporting in clinical trials with SAS" - february 2013]]>
Presented at BIAS "Data handling and reporting in clinical trials with SAS" - february 2013]]> Fri, 25 Oct 2013 10:11:40 GMT /slideshow/sas-conf-milan201302atinazzi/27570843 tinazzia@slideshare.net(tinazzia) CLINICAL STUDY REPORT - IN-TEXT TABLES, TABLES FIGURES AND GRAPHS, PATIENT AND INDIVIDUAL PATIENT DATA LISTINGS: ICH E3 TECHNICAL REQUISITES AND POSSIBLE SOLUTION IN SAS tinazzia Presented at BIAS "Data handling and reporting in clinical trials with SAS" - february 2013 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/sasconfmilan201302atinazzi-131025101140-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented at BIAS "Data handling and reporting in clinical trials with SAS" - february 2013

CLINICAL STUDY REPORT - IN-TEXT TABLES, TABLES FIGURES AND GRAPHS, PATIENT AND INDIVIDUAL PATIENT DATA LISTINGS: ICH E3 TECHNICAL REQUISITES AND POSSIBLE SOLUTION IN SAS from Angelo Tinazzi

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0 The Implementation of ICH Development Safety Update Report (DSUR) Guidance /slideshow/the-implementation-of-ich-development-safety-update-report-dsur-guidance/27570686 phusesdedsurconfbasel201306atinazzi-131025100634-phpapp02
Presented at PhUSE SDE Basel 2013]]>
Presented at PhUSE SDE Basel 2013]]> Fri, 25 Oct 2013 10:06:34 GMT /slideshow/the-implementation-of-ich-development-safety-update-report-dsur-guidance/27570686 tinazzia@slideshare.net(tinazzia) The Implementation of ICH Development Safety Update Report (DSUR) Guidance tinazzia Presented at PhUSE SDE Basel 2013 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/phusesdedsurconfbasel201306atinazzi-131025100634-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented at PhUSE SDE Basel 2013

The Implementation of ICH Development Safety Update Report (DSUR) Guidance from Angelo Tinazzi

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0 THE DO’S AND DON’TS OF DATA SUBMISSION /slideshow/the-dos-and-donts-of-data-submission/27570610 biasmilan201310atinazzi-131025100403-phpapp02
Presented at BIAS 2013 (Biometristi Italiani Associati) The state of the Art of Data Submission]]>
Presented at BIAS 2013 (Biometristi Italiani Associati) The state of the Art of Data Submission]]> Fri, 25 Oct 2013 10:04:02 GMT /slideshow/the-dos-and-donts-of-data-submission/27570610 tinazzia@slideshare.net(tinazzia) THE DO’S AND DON’TS OF DATA SUBMISSION tinazzia Presented at BIAS 2013 (Biometristi Italiani Associati) The state of the Art of Data Submission <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/biasmilan201310atinazzi-131025100403-phpapp02-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented at BIAS 2013 (Biometristi Italiani Associati) The state of the Art of Data Submission

THE DO’S AND DON’TS OF DATA SUBMISSION from Angelo Tinazzi

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0 Oncology Therapeutic Area Workshop /slideshow/oncology-therapeutic-area-workshop/27570534 taoncophuse2013tinazzi-131025100129-phpapp01
Workshop conducted at PhUSE 2013 Awarded as "Best Patient Centric Contribution"]]>
Workshop conducted at PhUSE 2013 Awarded as "Best Patient Centric Contribution"]]> Fri, 25 Oct 2013 10:01:29 GMT /slideshow/oncology-therapeutic-area-workshop/27570534 tinazzia@slideshare.net(tinazzia) Oncology Therapeutic Area Workshop tinazzia Workshop conducted at PhUSE 2013 Awarded as "Best Patient Centric Contribution" <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/taoncophuse2013tinazzi-131025100129-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Workshop conducted at PhUSE 2013 Awarded as "Best Patient Centric Contribution"

Oncology Therapeutic Area Workshop from Angelo Tinazzi

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0 Efficacy endpoints in Oncology /slideshow/is01-ppt/27570432 is01ppt-131025095828-phpapp01
Presented at PhUSE 2013 The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA). Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy endpoints. Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed.]]>
Presented at PhUSE 2013 The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA). Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy endpoints. Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed.]]> Fri, 25 Oct 2013 09:58:28 GMT /slideshow/is01-ppt/27570432 tinazzia@slideshare.net(tinazzia) Efficacy endpoints in Oncology tinazzia Presented at PhUSE 2013 The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA). Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy endpoints. Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/is01ppt-131025095828-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presented at PhUSE 2013 The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA). Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy endpoints. Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed.

Efficacy endpoints in Oncology from Angelo Tinazzi

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0 INTERPRETING CDISC ADaM IG THROUGH USERS INTERPRETATION /slideshow/cd01-ppt/27570282 cd01ppt-131025095358-phpapp01
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INTERPRETING CDISC ADaM IG THROUGH USERS INTERPRETATION from Angelo Tinazzi

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0 Web-Triage An Application for patient registration in phase I dose escalation studies /slideshow/webtriage-an-application-for-patient-registration-in-phase-i-dose-escalation-studies/12813311 mt02-13362491712384-phpapp01-120505153807-phpapp01
Presentation at PhUSE 2007]]>
Presentation at PhUSE 2007]]> Sat, 05 May 2012 15:20:56 GMT /slideshow/webtriage-an-application-for-patient-registration-in-phase-i-dose-escalation-studies/12813311 tinazzia@slideshare.net(tinazzia) Web-Triage An Application for patient registration in phase I dose escalation studies tinazzia Presentation at PhUSE 2007 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/mt02-13362491712384-phpapp01-120505153807-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds" /> Presentation at PhUSE 2007

Web-Triage An Application for patient registration in phase I dose escalation studies from Angelo Tinazzi

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0 https://cdn.slidesharecdn.com/profile-photo-tinazzia-48x48.jpg?cb=1580052811 I have more than 20 years of experience in the field of Clinical Research in the area of data-management and statistical programming with different roles in Academic Organisation, CRO and Pharmaceutical Industry, in Italy, Switzerland and UK. I have strong expertise in SAS programming and CDISC standards (mainly SDTM and ADaM). My core expertise is Oncology from phase I to phase IV; in the past I also had experience in Cardiovascular and Intensive Care therapeutic area. While working for Academic Organisation I had also the possibility to conduct epidemiology studies and systematic review of literature data (meta-analysis). As head of a data management team I also led the computer sy... https://cdn.slidesharecdn.com/ss_thumbnails/cdiscbasel2015atinazziadaptivedesigns-150509060505-lva1-app6891-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/adapting-cdisc-to-adaptive-design/47935255 Adapting CDISC to Adap... https://cdn.slidesharecdn.com/ss_thumbnails/pp08final-150401192347-conversion-gate01-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/adapting-to-adaptive/46558820 Adapting to Adaptive https://cdn.slidesharecdn.com/ss_thumbnails/biasgenoa201410atinazzi-141102154547-conversion-gate02-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/cdisc-sdtm-and-adam-for-survival-data/41025710 CDISC SDTM and ADaM fo...