Difference between revisions of "PHUSE Wiki"

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'''<big>Fridays @ 09:00 EDT, 14:00 BST. Check website for upcoming presentations</big>''' <br>
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'''<big>Click [https://www.phuse.eu/phuse-fda-data-science-innovation-challenge here] to listen back and view the presentations</big>''' <br>
 
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'''<big>Gone Virtual. Check website for updates </big>'''<br>
 
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'''<big>Registration to open shortly </big>'''<br>
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'''<big>[https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=332&ef_sel_menu=189&eventID=2&tempPersonID=1246 Registration] now open </big>'''<br>
 
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'''<big> Registration and Call for Papers Opens 1st June  </big>'''<br>
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'''<big> [https://www.phuse-events.org/attend/frontend/reg/tRegisterEmailNew.csp?pageID=968&ef_sel_menu=72&eventID=3&tempPersonID=1239 Registration] now open! Early Bird closes 31st July</big>'''<br>
 
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'''Deliverables out for public comment''': <br>
 
'''Deliverables out for public comment''': <br>
 
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Integration Strategies in Support of ISS/ISE Submissions Project has produced a White Paper and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''15th June'''.<br>
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The Analyses and Displays project has produced a White Paper and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''10th July'''. <br> <br>
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The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest). <br>
 
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This paper describes data integration strategy recommendations by the PHUSE SDTM/ADaM Implementation FAQ Project to support the Integrated Summary of Safety (ISS) and the Integrated Summary of Efficacy (ISE).<br>
 
 
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General Output Tips and Considerations project has produced a White Paper and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''10th July'''. <br> <br>
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This White Paper provides general advice on the display of data in tabular form.  The intent is educational and not prescriptive as an aid to considering how to present data in tables.
 
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Data De-Identification Standards project has produced a White Paper on Data Anonymisation and Risk Assessment Automation and is currently seeking [https://www.phuse.eu/cs-deliverables-under-review%20public%20feedback public feedback]. The closing date is '''5th June'''.
 
 
The objective of this paper is to draw a detailed dataset(s) anonymisation process map, identify 6 challenges and potential pitfalls of the process, suggest best practices and offer automation ideas and 7 examples
 
 
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'''Final Published Deliverables''' <br>
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The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click [https://phusewiki.org/docs/WorkingGroups/Deliverables/Data%20Anonymisation%20%26%20Risk%20Assessment%20Automation%20-%20Data%20Transparency.pdf here] to download. <br>
 
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The [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20DT%20Clinical%20Trial%20Landscape-%20Best%20Practices%20Guide.pdf Global View of the Clinical Transparency Landscape Best Practices Guide] builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms. <br>
 
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Real World Evidence Project are currently seeking [https://www.phuse.eu/cs-deliverables-under-review public feedback]. The closing date is '''5th June'''.<br>
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The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/PHUSE%20Clinical%20Trial%20Transparency%20and%20Disclosure%20White%20Paper.pdf here] to download the paper. <br>
 
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Usage of RWE in clinical trials for regulatory submissions is an area of research interest, due to the advantages in cost, cohort sizes and ethical considerations. This paper attempts to collate all related information such as sources of RWD privacy laws & use cases, in one document, which can act as a reference point for individuals or companies who wish to design, conduct, and submit studies using RWE. We begin with a summary of the RWE landscape before diving into some examples. The paper also lists FDA’s current thinking about the topic as of the date of this publication.
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'''Calling for Volunteers''' <br>
 
 
 
 
'''Final Published Deliverables''' <br>
 
 
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The Best Practices for Quality Control and Validation project have produced a White Paper which details the concepts, best practices and methods for quality control and validation of analysis programming used for clinical trials. Click [https://www.phusewiki.org/docs/WorkingGroups/Deliverables/Best%20Practices%20for%20Quality%20Control%20and%20Validation-%20White%20Paper%20.pdf here] to download the paper.  
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'''[[Harmonization_of_SEND_Implementation_to_Enable_Historical_Control_Data_Analysis|Harmonization of SEND Implementation to Enable Historical Control Data Analysis]]'''
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The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.<br>
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'''contact workinggroups@phuse.eu to get involved.'''
  
The Data Transparency team conducted a review of the Modernisation of ClinicalTrials.gov via the National Library of Medicine. The documented review can be found on the [https://www.phusewiki.org/docs/WorkingGroups/DataTransparency/PHUSE%20Response%20to%20ClinicalTrials.gov%20Modernization%20RFI%202020.pdf PHUSE website].
 
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'''The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project Blog'''<br>
 
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As the COVID-19 pandemic severely impacts many facets of human activity around the world, the pharmaceutical industry is being presented with significant challenges related to the manufacturing and shipping of existing marketed products and to treatment development activities. Regulatory authorities have released guidance documents focusing on the impacts to study start-up activities, changes to ongoing study procedures, and items considered urgent safety matters during this pandemic. This blog considers the impacts of COVID-19 on clinical study disclosure and transparency, offering guidance from industry experts on what may require immediate action, as well as consideration of future implications. To read the blog in full, click this [https://www.phuse.eu/blog/the-impacts-of-covid-19-on-clinical-trial-transparency-and-document-disclosure-phuse-ctt-project link].
 
 
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Latest revision as of 10:21, 3 July 2020

Welcome to the PHUSE Wiki


The PHUSE Wiki is an PHUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.


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Currently 6,861 users are helping to Connect, Share, Advance clinical informatics.


All content on this wiki is non-binding. All content expresses opinions of users and not necessarily that of their employer nor PHUSE. See our Disclaimers page

Need help with the Wiki? Ideas to Improve?

The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PHUSE Members. If you have a question, query or need help, please use this 'Discussion Forum'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact wendy@phuse.eu



PHUSE Events



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Click here to listen back and view the presentations

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Gone Virtual. Check website for updates

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Registration now open

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Registration now open! Early Bird closes 31st July


Become a PHUSE Member

There are many benefits to becoming a PHUSE member. Here's just a few reasons why you want to become part of something amazing

  • Free attendance to a range of Single Day Events held across US, EU and Asia
  • Access to PHUSE Blog
  • Full access to PHUSE Archives
  • Participation in our annual US & EU Connects and the US Computational Science Symposium


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Working Groups News


Deliverables out for public comment:


The Analyses and Displays project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

The White Paper is intended to provide recommendations on analyses and displays to sponsors who are planning analyses for Safety Topics of Interest for Phase 2-4 Clinical Trials and Integrated Summary documents (or other documents in which analyses of safety are of interest).


General Output Tips and Considerations project has produced a White Paper and is currently seeking public feedback. The closing date is 10th July.

This White Paper provides general advice on the display of data in tabular form. The intent is educational and not prescriptive as an aid to considering how to present data in tables.

Final Published Deliverables

The Data De-Identification Toolkit project has published a White Paper which draws a detailed dataset(s) anonymisation process map. The paper identifies challenges and potential pitfalls of the process, suggest best practices and offers automation ideas and examples. Click here to download.

The Global View of the Clinical Transparency Landscape Best Practices Guide builds upon the “Clinical Trial Transparency and Disclosure: A Global View” White Paper listed below. In this Best Practices Guide, subject matter experts share recommendations with the aim of fostering a holistic approach to clinical data transparency and disclosure that provides accurate and complete information across multiple disclosure platforms.

The Clinical Trial Transparency and Disclosure: A Global View White Paper was developed by industry experts with the goal of highlighting the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. Click here to download the paper.

Calling for Volunteers

Harmonization of SEND Implementation to Enable Historical Control Data Analysis The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data. Harmonizing the implementation and use of SEND is expected to benefit all involved stakeholders and to ultimately contribute to the goal of increased productivity in nonclinical research.
contact workinggroups@phuse.eu to get involved.



Industry News

GDPR has gone live. Please review PHUSE Privacy Policy

PHUSE Collaborations

Here's the link to the latest version of the Technical Conformance Guide (TCG) which was updated by the FDA March 2020




Last revision by WendyDobson, 07/3/2020