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Journal Club

Sponsored by Wiley


How does the Journal webinar work?

Journal webinars are held every few months and last about an hour. Journal papers are carefully selected from recent issues of the Royal Statistical Society's journals by editorial board for their importance, relevance and/or use of cutting-edge methodology; and authors are invited to present their work and take questions from an audience who 'dial in' to access the webinar.

Two papers are selected from our journals and authors will be invited to present their papers (20 minutes) followed by discussion (25 minutes) for each paper. Attendees will dial into a teleconference call. Papers and slides will be available to download two weeks in advance or you can log into the conference system and follow the presentation live online. These sessions are open to members and non-members. No need to pre-register. Audio recordings will be available for download shortly after the session.

It’s simple and free to join the webinar.

Questions on the paper or general queries can be emailed in advance of the session to journalwebinar@rss.org.uk.

Dial-in details

Go to following web page: http://mci-group.globalmeet.com/psijournalclub

Choose “Enter as a guest”, and enter your name and email address

A pop up box will appear called ‘CONNECT AUDIO’.  You may choose ‘CALL MY PHONE’ or ‘CALL MY COMPUTER’ or you can close the pop up box and dial in using your telephone on +44 (0) 330 336 6011 and Passcode: 497 034 0644 # (please see here for local phone numbers for outside the UK).  You can dial in using your telephone without joining the online webinar, and follow the presentations using slidedecks downloaded in advance.

Next event

Wednesday 12 July 2017, 2.30pm BST

Once a year, the RSS and PSI hold a joint webinar and this year’s joint event will follow the theme of 'adaptive signature design'.

Joint webinars focus on one key paper from the PSI, one from the RSS Journal. One or more discussants are also invited to join.

RSS author & paper 

zhiwei-zhang
Zhiwei Zhang, 'Subgroup Selection in Adaptive Signature Designs of Confirmatory Clinical Trials', published February 2017 in JRSS Series C, Volume 2.
Co-authored by Meijuan Li, Min Lin, Guoxing Soon, Tom Greene and Changyu Shen.

Abstract: The increasing awareness of treatment effect heterogeneity has motivated flexible designs of confirmatory clinical trials that prospectively allow investigators to test for treatment efficacy for a subpopulation of patients in addition to the entire population. If a target subpopulation is not well characterized in the design stage, it can be developed at the end of a broad eligibility trial under an adaptive signature design. The paper proposes new procedures for subgroup selection and treatment effect estimation (for the selected subgroup) under an adaptive signature design. We first provide a simple and general characterization of the optimal subgroup that maximizes the power for demonstrating treatment efficacy or the expected gain based on a specified utility function. This characterization motivates a procedure for subgroup selection that involves prediction modelling, augmented inverse probability weighting and low dimensional maximization. A cross-validation procedure can be used to remove or reduce any resubstitution bias that may result from subgroup selection, and a bootstrap procedure can be used to make inference about the treatment effect in the subgroup selected. The approach proposed is evaluated in simulation studies and illustrated with real examples.

Dr Zhiwei Zhang is Associate Professor of Biostatistics at the University of California, Riverside. He received his PhD in Biostatistics from the University of Pittsburgh in 2004. Prior to his current position, he has worked at the US Food and Drug Administration (as Mathematical Statistician) and the US National Institutes of Health (as Investigator of Biostatistics). Dr. Zhang has done methodological research in many areas of biostatistics, including causal inference, precision medicine, and clinical trial design and analysis.

 

PSI author & paper

Gu-Mi
Gu Mi, 'Enhancement of the adaptive signature design for learning and confirming in a single pivotal trial' published May 2017 in Pharmaceutical Statistics.

Abstract: Because of the complexity of cancer biology, often the target pathway is not well understood at the time that phase III trials are initiated. A 2-stage trial design was previously proposed for identifying a subgroup of interest in a learn stage, on the basis of 1 or more baseline biomarkers, and then subsequently confirming it in a confirmation stage. In this article, we discuss some practical aspects of this type of design and describe an enhancement to this approach that can be built into the study randomization to increase the robustness of the evaluation. Furthermore, we show via simulation studies how the proportion of patients allocated to the learn stage versus the confirm stage impacts the power and provide recommendations.

Dr Gu Mi is a Research Scientist at Eli Lilly and Company in Indianapolis, Indiana, USA. He received his PhD in statistics from Oregon State University in June 2014. He has been a clinical and biomarker statistician at Lilly Oncology with hands-on experience of oncology trials. He has been actively involved in trial designs, statistical methodology development in oncology, biomarker data analyses, and regulatory activities. He has been serving as an expert reviewer for eight peer-reviewed journals covering topics such as biopharmaceutical statistics, clinical trials, and bioinformatics.

RSS author & paper: 

 


What is PSI's Pharmaceutical Statistics Journal Club?

PSI's Pharmaceutical Statistics Journal Club is a free-to-attend virtual meeting which takes place quarterly. PSI members and non-members alike are welcome to join the meetings. Journal Club meetings feature papers from PSI's official journal Pharmaceutical Statistics which is published by John Wiley & Sons, Ltd. The authors of two papers are invited to present their work and each presentation is followed by a discussion.

The full version of the papers being presented at each meeting are freely available to all for a period around the Journal Club meeting date. The details of upcoming meetings will always be available on this page.


 
Past Journal Club Meetings

Journal Club meetings are recorded and made available via psiweb.org. Individual presentations and the audio recordings can be accessed from psiweb.org shortly after the event. 

Click here for details of all previous meetings.

How does PSI's Pharmaceutical Statistics Journal Club work?

  • Journal Club meetings are held quarterly and last 1½ hours.
  • Two papers will be selected from Pharmaceutical Statistics and authors will be invited to present their papers (20 mins) followed by discussion (25 mins) for each paper.
  • Attendees dial into an interactive web facility or through a TC, to follow along with the speaker.
  • Papers and slides will be available to download beforehand from this page. 
  • These TCs are open to both PSI & non-PSI members. There's no need to pre-register, so just block out the date and time in your calendar.
  • Audio recordings will be available shortly after the TCs to download should you wish to catch up on the event or just listen again.

Further information

For further information or to provide feedback on PSI's Pharmaceutical Statistics Journal Club, please contact journalclub@psiweb.org.

Further details on Wiley, sponsor of PSI's PST Journal Clubs can be found at www.wiley.com. For details of other PSI Events please visit the events page, or for information on joining PSI please click here.

 
 
 
 

 

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