BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD DTSTART;VALUE=DATE:20250101 TZNAME:UTC TZOFFSETFROM:+0000 TZOFFSETTO:+0000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Dates: \;Session 1 - Tuesday 20th October 2026Session 2 - W ednesday 21st October 2026Time: \;13:00 - 16:00 BST | 14:00 - 17:00 CE T | 08:00 - 11:00 EETLocation: \;Online via ZoomWho is this event inte nded for?Fully open. Statisticians in clinical research\, all stages of ca reerWhat is the benefit of attending?Gain a practical understanding of ada ptive clinical trial designs and the principles of ICH E20\, enabling you to make more informed contributions to the planning\, conduct\, and evalua tion of adaptive clinical studies within modern drug development.OverviewT his two-afternoon virtual course provides a practical introduction to adap tive clinical trials\, focusing on the concepts\, applications\, and regul atory principles outlined in ICH E20 through real-world examples and case studies.AbstractAdaptive clinical trials have moved from being viewed as s pecialized methodological innovations to becoming an increasingly importan t component of modern drug development. When appropriately planned\, condu cted\, and interpreted\, adaptive designs can improve the efficiency of cl inical drug development\, make better use of accumulating information\, an d support more informed decision-making. At the same time\, they raise imp ortant statistical\, operational\, and regulatory considerations\, particu larly in confirmatory settings where control of error rates\, trial integr ity\, and interpretability remain paramount. This virtual course\, deliver ed over two afternoons\, provides a structured introduction to adaptive cl inical trials for participants seeking a scientifically grounded and pract ice-oriented overview of the field. Rather than focusing on technical deri vations\, the course will emphasize conceptual understanding\, practical d esign considerations\, and learning through examples.A central component o f the course will be an introduction to ICH E20 and its implications for t he design\, conduct\, analysis\, and interpretation of adaptive clinical t rials. The course will explain the underlying rationale of the guideline a nd discuss how it frames adaptive design principles within a broader regul atory and scientific context. Particular attention will be given to princi ples such as adequacy within the development program\, adequacy of trial p lanning\, limiting the chances of erroneous conclusions\, reliability of e stimation\, and maintenance of trial integrity. The aim is not to summariz e the main themes of the guidance\, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-function al decision-making.The course will discuss common types of adaptations\, w ith a focus on specific considerations relevant to the principles. The met hodological component is intentionally selective and accessible rather tha n exhaustive. It will cover early\, among others\, trial stopping\, sample size adaptations\, population selection\, and treatment selection. Applic ations and case studies will form an important part of the training. Reali stic examples will be used to illustrate when adaptive approaches can add value\, when they may be less useful\, and how design choices should be al igned with the scientific question\, the stage of development\, and the pr actical realities of trial conduct. These examples will also show how adap tive designs are evaluated by different stakeholders\, including statistic ians\, clinicians\, regulators\, and development teams.Finally\, the cours e will address the broader strategic value of adaptive designs in drug dev elopment. Adaptive methods should not be viewed merely as technical tools\ , but as part of a broader framework for managing uncertainty\, improving development efficiency\, and aligning evidence generation with decision-ma king needs. Participants will come away with a clearer understanding of th e opportunities\, limitations\, and implementation requirements of adaptiv e clinical trials\, as well as a more informed perspective on when their u se is scientifically and strategically justified.CostEarly Bird PSI Member s: \;£\;180 +VATPSI Members: \;£\;210 +VATEarly Bird Non -PSI Members: \;£\;290 +VATNon-PSI Members: \;£\;320 +VA T*Please note: Non-Member rates include PSI membership until 31 Dec. 2027. RegistrationEarly Bird registration closes on Friday 28th August.To regist er for this event\, please \;click here.Speaker details\n .table img { \n width: 150px\;\n height: 225px\;\n object-fit: cover\;\n }\n \nSpeakerBiographyFrank Bretz\, NovartisFrank Bretz is a Distingu ished Quantitative Research Scientist at Novartis. He has contributed to m ethodological advancements in several areas of drug development\, includin g adaptive designs\, dose finding\, estimands\, and multiple testing. He w as a member of the ICH E9(R1) Expert Working Group on &ldquo\;Estimands an d sensitivity analysis in clinical trials&rdquo\;\, a subject matter exper t for the ICH M11 Expert Working Group on &ldquo\;Clinical electronic stru ctured harmonised protocol&rdquo\;\, and currently serves on the ICH E20 E xpert Working Group on &ldquo\;Adaptive designs for clinical trials&rdquo\ ;.Speaker 2 details coming soon \; DTEND:20261021T160000Z DTSTAMP:20260708T184605Z DTSTART:20261020T130000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Training Course: Adaptive Designs UID:RFCALITEM639191331651824786 X-ALT-DESC;FMTTYPE=text/html:

Dates: \;
Session 1 - Tuesday 20th October 2026
Session 2 - Wednesday 21st October 202 6
Time: \;13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET
Location: \;Online via Zoom< br />

Who is this event intended for?

Fully open. Statisticians in clinical research\, all stages of c areer

What is the benefit of attending?

Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20\, enabling you to make more informed contributions to the planning\, conduct\, and evaluation of adaptive clinical studies wi thin modern drug development.

Overview

This two-afternoon vi rtual course provides a practical introduction to adaptive clinical trials \, focusing on the concepts\, applications\, and regulatory principles out lined in ICH E20 through real-world examples and case studies.

Abst ract

Adaptive clinical trials have moved from being viewed as speci alized methodological innovations to becoming an increasingly important co mponent of modern drug development. When appropriately planned\, conducted \, and interpreted\, adaptive designs can improve the efficiency of clinic al drug development\, make better use of accumulating information\, and su pport more informed decision-making. At the same time\, they raise importa nt statistical\, operational\, and regulatory considerations\, particularl y in confirmatory settings where control of error rates\, trial integrity\ , and interpretability remain paramount. This virtual course\, delivered o ver two afternoons\, provides a structured introduction to adaptive clinic al trials for participants seeking a scientifically grounded and practice- oriented overview of the field. Rather than focusing on technical derivati ons\, the course will emphasize conceptual understanding\, practical desig n considerations\, and learning through examples.

A central co mponent of the course will be an introduction to ICH E20 and its implicati ons for the design\, conduct\, analysis\, and interpretation of adaptive c linical trials. The course will explain the underlying rationale of the gu ideline and discuss how it frames adaptive design principles within a broa der regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program\, adequacy o f trial planning\, limiting the chances of erroneous conclusions\, reliabi lity of estimation\, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance\, but how to place adaptive des igns into the wider landscape of a clinical development strategy and cross -functional decision-making.

The course will discuss common ty pes of adaptations\, with a focus on specific considerations relevant to t he principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early\, among others\, t rial stopping\, sample size adaptations\, population selection\, and treat ment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adapti ve approaches can add value\, when they may be less useful\, and how desig n choices should be aligned with the scientific question\, the stage of de velopment\, and the practical realities of trial conduct. These examples w ill also show how adaptive designs are evaluated by different stakeholders \, including statisticians\, clinicians\, regulators\, and development tea ms.

Finally\, the course will address the broader strategic va lue of adaptive designs in drug development. Adaptive methods should not b e viewed merely as technical tools\, but as part of a broader framework fo r managing uncertainty\, improving development efficiency\, and aligning e vidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities\, limitations\, and imp lementation requirements of adaptive clinical trials\, as well as a more i nformed perspective on when their use is scientifically and strategically justified.

Cost

Early Bird PSI Members: \;£\;180 +VAT
PSI Members: \;£\;210 + VAT

Early Bird Non-PSI Members: \;£\; 290 +VAT
Non-PSI Members: \;£\;320 +VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2027.

Registration

Early Bird registration closes on Friday 28th August.
To register for this event\, pleas e \;click here.

Speaker details

\n \n

SpeakerBiography

Frank Bretz\, Novartis

Frank Bretz is a Dis tinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development\, inc luding adaptive designs\, dose finding\, estimands\, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on &ldquo\;Estiman ds and sensitivity analysis in clinical trials&rdquo\;\, a subject matter expert for the ICH M11 Expert Working Group on &ldquo\;Clinical electronic structured harmonised protocol&rdquo\;\, and currently serves on the ICH E20 Expert Working Group on &ldquo\;Adaptive designs for clinical trials&r dquo\;.

Speaker 2 details coming soon

 \;

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