BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20231002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20230301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:This webinar aims to take a practical approach to some of the t rials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical analyses may not have gone as expected! As well as covering some of the errors often seen by the MHRA whilst reviewing submissions. \; Trials and Errors in Submission s: A Regulatory Perspective \;\nYolanda Barbachano (MHRA) Working in a regulatory agency means seeing dossiers from a variety of companies and d isease areas. There are some statistical issues that keep appearing again and again\, such as the choice of analysis population\, whilst other probl ems are more unusual but often more important. \; This talk will descr ibe some of the statistical issues regulators come across when assessing d ossiers for marketing authorisation applications and how some of these pro blems could be avoided. Topics covered will include the choice of analysis populations\, missing data\, sensitivity analyses and the use of long ter m extension studies to establish efficacy. An example of Issues with Multi plicity Adjustments\nSophie Dimonaco (Roche) There are many well-documente d methods to control for multiplicity in clinical trials\, all with their own set of pros and cons. This presentation will go through a real life ex ample of a Phase III trial investigating three active treatment arms versu s a control\, where the chosen multiplicity method was Hierarchical Testin g\, with a chain of >\;40 endpoints. The aim of the presentation is to e xplain the rationale of why this multiplicity methodology was chosen\, wha t happened when the chain broke early and the many discussions within the team post database lock about whether we had used the right adjustment met hod and what that meant for data with very important clinical significance that was statistically significant after the chain break.  \;\nSubmis sion Challenges: A real life example (Working Title)\nDavid Lawrence (Nova rits) David will be speaking regarding his experience of a recent phase 2/ 3 adaptive design trial which received a licence in the EU but not from th e FDA. (Further details TBC) Registration fee: None This webinar is free o f charge. However\, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link. \nWe do encourage your p articipation. If you have questions relating to the Trials &\; Errors i n Clinical Trials webinar\, or any of the listed talks\, ahead of the webi nar\, please email them to \;Lucy.rowell@roche.com \;and \;Chr is.Saville@iconplc.com \nWe will do our best to discuss them at the webina r.\n- See more at: http://www.psiweb.org/events/past-events/2014/trials-an d-errors-in-clinical-trials#sthash.rFHr9q9j.dpuf DTEND:20140311T150000Z DTSTAMP:20240329T060600Z DTSTART:20140311T130000Z LOCATION: SEQUENCE:0 SUMMARY:Trials and Errors in Clinical Trials UID:RFCALITEM638472891601811981 X-ALT-DESC;FMTTYPE=text/html:
This webinar aims to take a practical appro ach to some of the trials and errors seen in Clinical Trials. The webinar will go through some real life examples of where trials and statistical an alyses may not have gone as expected! As well as covering some of the erro rs often seen by the MHRA whilst reviewing submissions. \;
Tria
ls and Errors in Submissions: A Regulatory Perspective \;
\nYolan
da Barbachano (MHRA)
Working in a regulatory agency means seeing do ssiers from a variety of companies and disease areas. There are some stati stical issues that keep appearing again and again\, such as the choice of analysis population\, whilst other problems are more unusual but often mor e important. \; This talk will describe some of the statistical issues regulators come across when assessing dossiers for marketing authorisatio n applications and how some of these problems could be avoided. Topics cov ered will include the choice of analysis populations\, missing data\, sens itivity analyses and the use of long term extension studies to establish e fficacy.
An example of Issues with Multiplicity Adjustments
\n
Sophie Dimonaco (Roche)
There are many well-documented methods to c ontrol for multiplicity in clinical trials\, all with their own set of pro s and cons. This presentation will go through a real life example of a Pha se III trial investigating three active treatment arms versus a control\, where the chosen multiplicity method was Hierarchical Testing\, with a cha in of >\;40 endpoints. The aim of the presentation is to explain the rat ionale of why this multiplicity methodology was chosen\, what happened whe n the chain broke early and the many discussions within the team post data base lock about whether we had used the right adjustment method and what t hat meant for data with very important clinical significance that was stat istically significant after the chain break.
 \;
\nSubmiss
ion Challenges: A real life example (Working Title)
\nDavid Lawrence
(Novarits)
David will be speaking regarding his experience of a rec ent phase 2/3 adaptive design trial which received a licence in the EU but not from the FDA. (Further details TBC)
Registration fee: None
This webinar is free of charge. However\, attendees m
ust register on the PSI website in order to obtain the dial-in details and
the webinar link.
\nWe do encourage your participation. If yo
u have questions relating to the Trials &\; Errors in Clinical Trials w
ebinar\, or any of the listed talks\, ahead of the webinar\, please email
them to \;Lucy.rowell@roche.com
 \;and \;Chris.Savi
lle@iconplc.com
\nWe will do our best to discuss them at t
he webinar.