Difference between revisions of "WG5 Project 07"
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− | | Webinar 24.04.19 || [ | + | | Webinar 24.04.19 || [https://www.phusewiki.org/wiki/images/a/af/Safety_Analytics_Workshop.pptx Safety Analytics CSS Workshop] || Mary Nilsson & Nhi Beasley |
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| Webinar 23.01.19 || [https://www.phusewiki.org/wiki/images/c/cf/Script_Metadata_for_Sharing_Final_White_Paper_Webinar_23.01.19_.pptx Presentation on the Script for Metadata for Sharing Final White Paper] || Hanming Tu & Bob Friedman | | Webinar 23.01.19 || [https://www.phusewiki.org/wiki/images/c/cf/Script_Metadata_for_Sharing_Final_White_Paper_Webinar_23.01.19_.pptx Presentation on the Script for Metadata for Sharing Final White Paper] || Hanming Tu & Bob Friedman | ||
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| DIA 2019 || Abstract submitted for the Annual DIA Conference || [https://www.phusewiki.org/wiki/images/4/4c/DIA2018_ADWAbstract.docx Link] to abstract | | DIA 2019 || Abstract submitted for the Annual DIA Conference || [https://www.phusewiki.org/wiki/images/4/4c/DIA2018_ADWAbstract.docx Link] to abstract | ||
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− | | [https://www. | + | | DIA 2019 || [https://www.phusewiki.org/wiki/images/7/70/DIA2019_ClinicalSafetyAssessment_Nilsson_%281%29.pptx Presentation] || Mary Nilsson |
+ | |- | ||
+ | | Squarespace || Our new initiative on Education. Click [https://education.phuse.eu/overview here] to find out more about our Script Repository || Jared Slain | ||
|} | |} | ||
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| style="width:30%" | '''Topic''' || style="width:35%" | '''Presentation''' || style="width:20%" |'''Presenter''' | | style="width:30%" | '''Topic''' || style="width:35%" | '''Presentation''' || style="width:20%" |'''Presenter''' | ||
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− | | | + | | PHUSETube Publication || [https://www.youtube.com/watch?v=Ryyv-rKMsnI Script Metadata for Sharing] || Hanming Tu |
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− | | | + | |PHUSETube Publication Study-Size Adjusted Percentages. Why, What, When ||[https://www.youtube.com/watch?v=GGU6-Pmhq-g&t=45s Topics on Pooling Data from Multiple Studies] || Brenda Crowe |
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| White Paper Publication Version 2.0 || [https://www.phuse.eu/documents//working-groups/deliverables/analyses-displays-associated-with-demographics-disposition-medications-in-phase-2-4-clinical-trials-version-20-02-mar-18-11808.pdf Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents] || Mary Nilsson | | White Paper Publication Version 2.0 || [https://www.phuse.eu/documents//working-groups/deliverables/analyses-displays-associated-with-demographics-disposition-medications-in-phase-2-4-clinical-trials-version-20-02-mar-18-11808.pdf Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents] || Mary Nilsson | ||
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==== 2019 ==== | ==== 2019 ==== | ||
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|Sep 11-13 || [https://deming.org/events/47-deming-management-method-for-owners-executives-25-day-seminar-september-2019 W Edwards Deming] - Management Method for Owners & Executives || Registration Open || Tipp City, OH, USA | |Sep 11-13 || [https://deming.org/events/47-deming-management-method-for-owners-executives-25-day-seminar-september-2019 W Edwards Deming] - Management Method for Owners & Executives || Registration Open || Tipp City, OH, USA | ||
|- | |- | ||
− | |Sep | + | |Sep 11|| PHUSE Single Day Event || [https://www.phuse.eu/beerse-sde-2019 Registration opens August] || Beerse, Belguim |
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− | |Sep | + | |Sep 26 || PHUSE Single Day Event || [https://www.phuse.eu/north-wales-sde-2019 Registration opens August] || North Wales, Pennsylvania |
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|Sep TBC || CDISC Chinese Interchange || TBC || Beijing, China | |Sep TBC || CDISC Chinese Interchange || TBC || Beijing, China | ||
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− | |Oct 16-17 || CDISC USA Interchange || | + | |Oct 16-17 || [https://www.cdisc.org/2019-cdisc-us-interchange CDISC USA Interchange] || Posters / Abstracts Open || San Diego, California |
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− | |Oct TBC || PhUSE Single Day Event || | + | |Oct TBC || [https://www.phuse.eu/cincinnati-ohio-sde-2019 PhUSE Single Day Event] || Registration opens September || Cincinnati, Ohio |
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− | |Oct TBC || | + | |Oct TBC || PHUSE Single Day Event || Registration opens September || Chennai, India |
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− | |Nov 10-13 || [https://www.phuse.eu/eu-connect19 | + | |Nov 10-13 || [https://www.phuse.eu/eu-connect19 PHUSE EU Connect] || Early Bird Closes 26th July || Amsterdam, The Netherlands |
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− | |Nov TBC || | + | |Nov TBC || PHUSE Single Day Event || [https://www.phuse.eu/bloemfontein-sde-2019 Registration opens October] || Bloemfontein, South Africa |
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− | |Nov | + | |Nov 1 || PHUSE Single Day Event || [https://www.phuse.eu/shanghai-sde-2019 Registration opens October] || Shanghai, China |
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− | |Dec | + | |Dec 5 || [https://www.phuse.eu/durham-north-carolina-sde-2019 PhUSE Single Day Event] || Registration opens November || Durham, North Carolina |
|} | |} | ||
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* Implement Team (we need Writers, Networkers, Twitters) | * Implement Team (we need Writers, Networkers, Twitters) | ||
* "Something big" for 2017-2018 (and beyond)! | * "Something big" for 2017-2018 (and beyond)! | ||
− | * Increase visibility of White Papers and code repository on the | + | * Increase visibility of White Papers and code repository on the PHUSE website |
− | * Create a video on | + | * Create a video on PHUSE Tube how to work with the repository |
* Gain greater access to other interest groups | * Gain greater access to other interest groups | ||
* Inspire discussions & participation | * Inspire discussions & participation | ||
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***Safety is not that easy, and does require careful planning | ***Safety is not that easy, and does require careful planning | ||
***Need to raise the bar - Avoid confounding, avoid bias, include stratification by study where warranted, include indirect methodology where warranted, how to read certain displays and what to look for (box plot, spaghetti plot, etc), mean changes over time aren't the best for persistent/transient questions, leverage interactive capabilities | ***Need to raise the bar - Avoid confounding, avoid bias, include stratification by study where warranted, include indirect methodology where warranted, how to read certain displays and what to look for (box plot, spaghetti plot, etc), mean changes over time aren't the best for persistent/transient questions, leverage interactive capabilities | ||
− | ***To raise the bar, team members should take basic training specific to safety analyses prior to team participation (DIA training, | + | ***To raise the bar, team members should take basic training specific to safety analyses prior to team participation (DIA training, PHUSE white papers, PHUSEtube videos, etc.). We can provide a suggested list of reading/training in the manuscript with a link to a wiki page that allows for updating and discussion. |
***Common challenges/pitfalls and general ways to address the challenges | ***Common challenges/pitfalls and general ways to address the challenges | ||
**Signal detection, signal clarification, signal communication | **Signal detection, signal clarification, signal communication | ||
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|20April2018 || Upcoming Webinar and PhUSE Web Design|| [http://www.phusewiki.org/wiki/index.php?title=Upcoming_Webinar_and_PhUSE_Web_Design Minutes] | |20April2018 || Upcoming Webinar and PhUSE Web Design|| [http://www.phusewiki.org/wiki/index.php?title=Upcoming_Webinar_and_PhUSE_Web_Design Minutes] | ||
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− | |06April2018 || | + | |06April2018 || PHUSE Tube Video Creation and Misc Topics || [http://www.phusewiki.org/wiki/index.php?title=PhUSE_Tube_Video_Creation_and_Misc_Topics Minutes] |
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|28March2018 || 2018 CSS Discussion Continuation || [http://www.phusewiki.org/wiki/index.php?title=2018_CSS_Discussion_Continuation Minutes] | |28March2018 || 2018 CSS Discussion Continuation || [http://www.phusewiki.org/wiki/index.php?title=2018_CSS_Discussion_Continuation Minutes] |
Latest revision as of 09:38, 5 September 2019
Project Team
Project Lead:
Jared Slain and Wendy Dobson
Project Members:
We need your help! Please contact workinggroups@phuse.eu if you would like to volunteer for this project.
Project Description
- Project Name
- Communication, Promotion and Education
- Description
- The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation.
Project Progress
2019 Accomplishments
Webinar 24.04.19 | Safety Analytics CSS Workshop | Mary Nilsson & Nhi Beasley |
Webinar 23.01.19 | Presentation on the Script for Metadata for Sharing Final White Paper | Hanming Tu & Bob Friedman |
DIA 2019 | Abstract submitted for the Annual DIA Conference | Link to abstract |
DIA 2019 | Presentation | Mary Nilsson |
Squarespace | Our new initiative on Education. Click here to find out more about our Script Repository | Jared Slain |
Project Progress
- 2018 Milestones
Topic | Presentation | Presenter |
PHUSETube Publication | Script Metadata for Sharing | Hanming Tu |
PHUSETube Publication Study-Size Adjusted Percentages. Why, What, When | Topics on Pooling Data from Multiple Studies | Brenda Crowe |
White Paper Publication Version 2.0 | Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents | Mary Nilsson |
Standard Analyses & Code Sharing Presentation to FDA | Working Group Overview | Mary Nilsson & Hanming Tu |
Introduction to Poster for Frankfurt EU Connect - Streamline the Collaboration | From White Paper Targets (TFLs) to Shareable Scripts | Hanming Tu |
Webinar | GitHub Environment | Hanming Tu |
Webinar | CSS 2018 Working Group Output | Mary Nilsson & Hanming Tu |
CSS 2018 Presentations | Project Leads Slide Decks | All Project Leads |
Working Group | All Hands Meeting 29th Nov | Mary Nilsson & Hanming Tu |
ADW & Data Visualisation Meeting | Submissions Sub Team Project | Mary Nilsson |
2018 Posters/Abstracts
Topic | Presentation | Presenter |
Frankfurt EU Connect | Working Group Overview | Mary Nilsson & Hanming Tu |
MWSUG | Working Group Overview | Nancy Brucken and Jared Slain |
Abstract on Standard Analyses & Displays for Common Clinical Trial Data - An Industry-wide Initiative | JSM 30Jul2018 | Hanming Tu |
Spotfire User Group Meeting | Japan Spotfire User Group | Rebeka Revis |
WHODrug User Group Meeting | Recommended Summaries of Medication Data | Hanming Tu & Mary Nilsson |
Upcoming Opportunities
2019
Sep 11-13 | W Edwards Deming - Management Method for Owners & Executives | Registration Open | Tipp City, OH, USA |
Sep 11 | PHUSE Single Day Event | Registration opens August | Beerse, Belguim |
Sep 26 | PHUSE Single Day Event | Registration opens August | North Wales, Pennsylvania |
Sep TBC | CDISC Chinese Interchange | TBC | Beijing, China |
Oct 16-17 | CDISC USA Interchange | Posters / Abstracts Open | San Diego, California |
Oct TBC | PhUSE Single Day Event | Registration opens September | Cincinnati, Ohio |
Oct TBC | PHUSE Single Day Event | Registration opens September | Chennai, India |
Nov 10-13 | PHUSE EU Connect | Early Bird Closes 26th July | Amsterdam, The Netherlands |
Nov TBC | PHUSE Single Day Event | Registration opens October | Bloemfontein, South Africa |
Nov 1 | PHUSE Single Day Event | Registration opens October | Shanghai, China |
Dec 5 | PhUSE Single Day Event | Registration opens November | Durham, North Carolina |
Archived Events & Publications
Previous conferences and presentations
Action Items
- Implement Team (we need Writers, Networkers, Twitters)
- "Something big" for 2017-2018 (and beyond)!
- Increase visibility of White Papers and code repository on the PHUSE website
- Create a video on PHUSE Tube how to work with the repository
- Gain greater access to other interest groups
- Inspire discussions & participation
- Present progress at conferences
- Formal publication of White Papers
Journal Article Outline
- Journal pertaining to analyses and displays
- Key Messages or issues we're trying to address with the paper
- There are basic safety analytical principles that are not well understood - those involved with safety should obtain a base knowledge
- Certain behaviors within current practice need to stop (analyses with confounding, analyses with bias, lack of stratification, etc). We might need to provide examples of issues in current practice (eg, from briefing documents and/or labels). We might want a separate manuscript just on pooling issues with the example, the problem, and what could have been done instead.
- Current practice can be improved (especially with integrated analyses, but individual study analyses as well)
- While there are existing recommendations for analyses/displays, the rationale behind them and how to read them, and where they fit in the overall interpretation is not well understood
- Safety is not that easy, and does require careful planning
- Need to raise the bar - Avoid confounding, avoid bias, include stratification by study where warranted, include indirect methodology where warranted, how to read certain displays and what to look for (box plot, spaghetti plot, etc), mean changes over time aren't the best for persistent/transient questions, leverage interactive capabilities
- To raise the bar, team members should take basic training specific to safety analyses prior to team participation (DIA training, PHUSE white papers, PHUSEtube videos, etc.). We can provide a suggested list of reading/training in the manuscript with a link to a wiki page that allows for updating and discussion.
- Common challenges/pitfalls and general ways to address the challenges
- Signal detection, signal clarification, signal communication
- Get clarity on different needs
- Be a little provacative
- Point out mistakes that are being made
- Big signals aren't being missed, but we could be doing better: exposure times calculated incorrectly, data pooling
- Wasted energy creating and reviewing data that aren't helpful
- Allowing some interactive capabilities
- Draft Titles
- Raising the Bar in Premarketing Clinical Trial Safety Assessment
- Clinical Trial Safety Analyses - Why isn't it easy?
- Notes - Can we get access to the DIA Training "Premarketing Clinical Trial Safety" so we don't duplicate information?
- Key Messages or issues we're trying to address with the paper
Group Meetings
Date | Topic | Minutes |
14Dec2018 | Repository Front End Requirements | Minutes |
30Nov2018 | Organization of Past Presentation Materials | Minutes |
16Nov2018 | Repository and Safety Analytics Front Ends | Minutes |
02Nov2018 | Teamworks Demo | Minutes |
19Oct2018 | Review Priorities | Minutes |
04Oct2018 | Early October Meeting | Minutes |
07Sep2018 | Focus on Repository Front Door | Minutes |
24Aug2018 | WG Presentation to FDA | Minutes |
13July2018 | Friday the 13th of July Meeting | Minutes |
29June2018 | June Meeting | Minutes |
18May2018 | General Discussion and More PhUSE Web Design Work | Minutes |
04May2018 | Continuing Discussions | Minutes |
20April2018 | Upcoming Webinar and PhUSE Web Design | Minutes |
06April2018 | PHUSE Tube Video Creation and Misc Topics | Minutes |
28March2018 | 2018 CSS Discussion Continuation | Minutes |
4-6March2018 | Notes captured during CSS Breakout Sessions | |
28Feb2018 | Preparation for CSS 2018 | Minutes |
24Jan2018 | Early 2018, Something Big Deliverables | Minutes |
22Nov2017 | November Meeting (Potpourri of items) | Minutes |
26June2017 | Something Big - June Meeting | Minutes |
10May2017 | Kickoff for Something Big | Minutes |
Last revised by WendyDobson,09/5/2019