BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VEVENT DESCRIPTION:Presented by Rob Hemmings\, Frank Petavy\, Christine Fletcher\, Frank Bretz\n\n Rob Hemmings is a partner at Consilium Salmonson and H emmings. He was formally the manager of the statisticians and pharmacokine ticists at MHRA\; a member of the EMA&rsquo\;s CHMP and chair of the EMA&r squo\;s SAWP. \;\n Frank Pé\;tavy is Head of Biostatistics an d Methodology Support at the European Medicines Agency. He contributes to the provision of scientific advice for drug development and the assessment of marketing authorisation applications across therapeutic areas.\n Ch rissie Fletcher is the Global Therapeutic Head of Biostatistics for Cardio vascular\, Metabolic\, Neuroscience\, Bone\, Inflammation and Nephrology\, the European Regional Biostatistics Head and leads an HTA Biostatistics g roup at Amgen.\n Frank Bretz is Global Head of the Statistical Methodol ogy and Consulting group at Novartis. He has supported the methodological development in various areas of drug development\, including dose-finding\ , multiple comparisons\, and adaptive designs.\n\nAll of the speakers are members of the ICH Expert Working Group on this topic.\nAbout the course:& nbsp\;\nDefining the primary objective of a clinical trial in a precise wa y to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design\, the choice of statistical analysis a nd the interpretation of the results. This raises the need for a structure d framework to specify the primary estimand (i.e. "what is to be estimated "). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. All stakeholders are gaining t he necessary experience and familiarity with estimands along with the asso ciated challenges and methodologies. In this course we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the implementation of this framewor k in clinical trials.\n \;\nThe following topics will be covered:\n\n Introduction and motivation for the ICH E9 addendum\n - Understandin g treatment effects \;\n - Scope of the addendum to ICH E9\n - M otivating examples\n - Introduce a generic example to be a thread along the training course\n A framework to align planning\, design\, conduct \, analysis and interpretation\n - A new framework for clinical trials\ n - Alignment between trial objective\, design\, planning\, conduct\, a nalysis and interpretation\n - Implications on design and conduct of cl inical trials and in the performance of statistical analyses\n - How th is framework can improve discussions between sponsors and regulators on th e suitability of designs and the interpretation of results\n Descriptio n\, strategies and construction of estimands\n - Attributes that togeth er describe an estimand\n - Strategies for addressing intercurrent even ts\n - General considerations for the construction of estimands\n - Therapeutic and experimental considerations for the construction of estima nds\n Generic example and case studies (Part 1)\n - Generic example to illustrate the thinking process that aligns estimands and sensitivity a nalyses with trial objectives \;\n - Case studies in specific disea se settings: envisage a variety of options at the end of Day 1 and reconve ne in the morning of Day 2 to select the preferred option(s)\n Impact o n trial design and conduct\n - Implications on design and conduct of cl inical trials and in the performance of statistical analyses\n - Identi fication of estimand(s) at the design stage requires informed discussion w ith all stakeholders\n - Certain estimands may require or benefit from non-standard designs and/or endpoints\n Impact on trial analysis with f ocus on sensitivity analysis\n - Role and choice of sensitivity analysi s and supplementary analysis in light of the estimand framework\n - Mai n estimation\, sensitivity analysis\, role and choice of sensitivity analy sis\, supplementary analysis\n Documenting estimands and sensitivity an alysis\n - Impact of the addendum on protocol writing\, study design\, data analysis and interpretation\n - Incorporating estimands in the wri ting of a trial protocol and statistical analysis plan\n - Potential im pact of the ICH E9 addendum on study conduct\, data analysis and interpret ation\n Generic example and case studies (Part 2)\n - Use examples t o review the impact of using the estimand framework on study design and da ta collection\; on the choice of estimation methods and sensitivity analys is \;\n\n \;Course runs from: 10:00 &ndash\; 17:30 (registration f rom 9:30) on Day 1 \;\n \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \;  \; & nbsp\;  \; 09:00 &ndash\; 16:30 on Day 2.\n \;\n\nRegistration\n\n \n \n  \;\n \n Early Bird (Up To &\; Including 24th April) \;\n After 24th April\n \n \n \n PSI Member\n &pou nd\;495 + VAT\n £\;595 + VAT\n \n \n Non-Member\n £\;570 + VAT (This includes PSI membershi p for 2019)\n £\;670 + VAT \;(This includes PSI member ship for 2019)\n \n \n\n\nPlease click here \;to register.\n \nRegistration costs include lunch and refreshments. PSI are holding a lim ited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact \;psi@mci-group.com&n bsp\;to reserve a room. Rooms are charged at £\;109.00 inc VAT per ro om including breakfast. DTEND;VALUE=DATE:20190524 DTSTAMP:20260721T172124Z DTSTART;VALUE=DATE:20190522 LOCATION: SEQUENCE:0 SUMMARY:Estimands and Sensitivity Analysis in Clinical Trials UID:RFCALITEM639202512848691708 X-ALT-DESC;FMTTYPE=text/html:

Presented by Rob Hemmings\, Frank Petavy\, Christine Fletcher\, Frank Bretz

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All of the speakers are members of the ICH Expert Working Group on this topic.
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About the course: \;

\nDefining the primary objective of a cl inical trial in a precise way to reflect the presence of non-compliance or non-adherence to treatment is crucial for the choice of design\, the choi ce of statistical analysis and the interpretation of the results. This rai ses the need for a structured framework to specify the primary estimand (i .e. "what is to be estimated"). This is also reflected by the decision of the International Council on Harmonization (ICH) to amend its E9 guidance by discussing estimands and their role in clinical trials. The draft ICH E 9 addendum on estimands and sensitivity analysis was released back in July 2017 and is being finalised while considering more than 1000 comments. Al l stakeholders are gaining the necessary experience and familiarity with e stimands along with the associated challenges and methodologies. In this c ourse we provide an in-depth review of the estimand framework as laid out by the draft ICH E9 addendum and present case studies illustrating the imp lementation of this framework in clinical trials.\n
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The following topics will be covered:

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 \;Course runs from: 10:00 &ndash\; 17:30 (registration from 9:30) on Day 1 \;
\n \;  \;  \;  \;  \;  \;  \; & nbsp\;  \;  \;  \;  \;  \;  \;  \;  \; &nb sp\; 09:00 &ndash\; 16:30 on Day 2.
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Registration

\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n
 \;\n Early Bird (Up To &\; Including 24th April) \;After 24th April\n
PSI Member£\ ;495 + VAT&po und\;595 + VAT
Non-Me mber£\;57 0 + VAT (This includes PSI membership for 2019)£\;670 + VAT \;(Th is includes PSI membership for 2019)
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\nPlease click here \;to reg ister.
\n
\nRegistration costs include lunch and refreshments. P SI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact \ ;psi@mci-group.com \;to reserve a room. Rooms are charged at £\;109.00 inc VAT per room including br eakfast. END:VEVENT END:VCALENDAR