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DTSTART:20251002T030000
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BEGIN:VEVENT
DESCRIPTION:Time: 16:00 - 17:30 (UK Time)\n\n\nOur next journal club\, held
  jointly with the DIA\, features two papers on the topic of Statistical Co
 nsiderations for Innovative Designs in Clinical Trials. Please join us to 
 hear Jason Yuan and Xiangmin Zhang present their recent work:\n\nSPEAKER: 
 Jason Yuan (Allergan)\nClinical Study Design to Assess Both Short- and Lon
 g-term Efficacy in Addition to Group Sequential Test on Safety\nClick here
  to view the presentation slides\nAuthors: Jiacheng Yuan\, Peter Mesenbrin
 k\, Jihao Zhou\, Jeen Liu\, Ray Zhu\, and Gary Koch. \nTherapeutic Innovat
 ion &amp\; Regulatory Science 2018\, Vol. 52(6) 690-695\nSPEAKER: Xiangmin
  Zhang (FDA)&nbsp\;\nThe plan of enrichment designs for dealing with high 
 placebo response\nClick here to view the presentation slides\nAuthors: Xia
 ngmin Zhang\, Yeh‐Fong Chen\, Roy Tamura. \nPharmaceutical Statistics\, Vo
 lume 17\, Issue1\, January/February 2018 Pages 25-37\n\nDiscussants: Dr. J
 im Hung (FDA) and Peter Zhang (Otsuka)\n\nREGISTER HERE: \nhttps://attende
 e.gotowebinar.com/register/8012010784519787779\n&nbsp\;\nIn preparation an
 d prior to the day of the webinar\, please follow the link above to obtain
  your personal dial in details and register with the webinar software. Aft
 er registering via this link\, you will receive a confirmation email conta
 ining information about joining the webinar\, including details on how to 
 dial-in via the telephone. Please allow enough time before joining to down
 load the correct software.\nPapers available to view prior to the meeting 
 on http://www.psiweb.org/events/journal-club and presentation slides will 
 be available a week before the JC.&nbsp\; Journal subscribers can access p
 apers at any time.&nbsp\; Audio recordings will be available shortly after
  the JC to download from the PSI website. The meetings are open to PSI and
  non-PSI members. \nWe encourage you to read these papers in advance so yo
 u get the most from this event. For further info/feedback\, or to submit a
  question to the authors in advance of the meeting please contact journalc
 lub@psiweb.org \n
DTEND:20181211T163000Z
DTSTAMP:20261009T103930Z
DTSTART:20181211T150000Z
LOCATION:
SEQUENCE:0
SUMMARY:PSI and DIA Journal Club: Statistical Considerations for Innovative
  Designs in Clinical Trials
UID:RFCALITEM639271391703565855
X-ALT-DESC;FMTTYPE=text/html:<strong>Time: </strong>16:00 - 17:30 (UK Time)
 <strong><br />\n<br />\n</strong>\n<p>Our next journal club\, held jointly
  with the DIA\, features two papers on the topic of Statistical Considerat
 ions for Innovative Designs in Clinical Trials. Please join us to hear Jas
 on Yuan and Xiangmin Zhang present their recent work:</p>\n<br />\n<p><str
 ong>SPEAKER: </strong><strong>Jason Yuan (Allergan)<br />\n</strong><stron
 g><a href="https://journals.sagepub.com/doi/pdf/10.1177/2168479018759660">
 Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addi
 tion to Group Sequential Test on Safety</a><br />\n</strong><a href="https
 ://www.psiweb.org/docs/default-source/default-document-library/design-to-a
 ssess-short-and-long-term-efficacy-in-addition-to-safety.pdf?sfvrsn=6fdcd8
 db_0&sf_site_temp=true&sf_site=00000000-0000-0000-0000-000000000000" title
 ="Click here to view the presentation slides">Click here to view the prese
 ntation slides</a><strong><br />\n</strong>Authors: Jiacheng Yuan\, Peter 
 Mesenbrink\, Jihao Zhou\, Jeen Liu\, Ray Zhu\, and Gary Koch. <br />\nTher
 apeutic Innovation &amp\; Regulatory Science 2018\, Vol. 52(6) 690-695</p>
 \n<strong>SPEAKER: Xiangmin Zhang (FDA)&nbsp\;<br />\n</strong><strong><a 
 href="https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Furl
 defense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__onlinelibrary.wiley.com_
 doi_full_10.1002_pst.1833%26d%3DDwMFaQ%26c%3DSexio4usKrYWFsrnxgjbcQ%26r%3D
 wriB2Y0sK4q8yBO4xa4tFK0gjjOVgdcrySv-flUGdPM%26m%3DM5U_5FGMaDNTyy5XXGC42Dw8
 rSs0QfMw3CX2TwsNZvw%26s%3D1HYIbfre23q-oIY60UPQmg8azu9mJ4XPvRxF2lhIj9g%26e%
 3D&amp\;data=02%7C01%7CJack.Elkes%40quintiles.com%7C862b84e4cd38479a609808
 d640a5fab4%7C5989ece0f90e40bf9c791a7beccdb861%7C1%7C0%7C636767479105833807
 &amp\;sdata=CVZIniGaKjWhYlwWp43%2FnWBNERj7%2BgBTrMm6X5P0DiU%3D&amp\;reserv
 ed=0">The plan of enrichment designs for dealing with high placebo respons
 e</a><br />\n</strong><a href="https://www.psiweb.org/docs/default-source/
 default-document-library/psi-dia-journal-club-dec-2018-xiangmin-zhang.pdf?
 sfvrsn=7fdcd8db_0&sf_site_temp=true&sf_site=00000000-0000-0000-0000-000000
 000000" title="Click here to view the presentation slides">Click here to v
 iew the presentation slides</a><br />\nAuthors: Xiangmin Zhang\, Yeh‐Fong 
 Chen\, Roy Tamura. <br />\nPharmaceutical Statistics\, Volume 17\, Issue1\
 , January/February 2018 Pages 25-37<br />\n<br />\nDiscussants: Dr. Jim Hu
 ng (FDA) and Peter Zhang (Otsuka)<br />\n<br />\n<h4>REGISTER HERE: </h4>\
 n<a href="https://attendee.gotowebinar.com/register/8012010784519787779">h
 ttps://attendee.gotowebinar.com/register/8012010784519787779</a><br />\n&n
 bsp\;<br />\n<p>In preparation and prior to the day of the webinar\, pleas
 e follow the link above to obtain your personal dial in details and regist
 er with the webinar software. After registering via this link\, you will r
 eceive a confirmation email containing information about joining the webin
 ar\, including details on how to dial-in via the telephone. Please allow e
 nough time before joining to download the correct software.</p>\n<p>Papers
  available to view prior to the meeting on <a href="http://www.psiweb.org/
 events/journal-club">http://www.psiweb.org/events/journal-club</a> and pre
 sentation slides will be available a week before the JC.&nbsp\; Journal su
 bscribers can access papers at any time.&nbsp\; Audio recordings will be a
 vailable shortly after the JC to download from the PSI website. The meetin
 gs are open to PSI and non-PSI members. </p>\n<p>We encourage you to read 
 these papers in advance so you get the most from this event. For further i
 nfo/feedback\, or to submit a question to the authors in advance of the me
 eting please contact <a href="mailto:journalclub@psiweb.org">journalclub@p
 siweb.org</a> </p>\n<p><strong></strong></p>
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