Difference between revisions of "Policy, Guidance and Material Reviews"

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* [https://www.ema.europa.eu/documents/comments/overview-comments-received-publication-access-clinical-trial-data-ema/240810/2013-stakeholder-89-108_en.pdf PhUSE Comments to EMA 'Publication and access to clinical-trial data', 2013 - Stakeholder 107, pages 87-92]
 
* [https://www.ema.europa.eu/documents/comments/overview-comments-received-publication-access-clinical-trial-data-ema/240810/2013-stakeholder-89-108_en.pdf PhUSE Comments to EMA 'Publication and access to clinical-trial data', 2013 - Stakeholder 107, pages 87-92]
 
*[https://www.phuse.eu/documents//working-groups/data-transparency/phuse-comments-to-gazette-09dec2017-part-i-v10-19896.pdf PhUSE Data Transparency Working Group’s Comments on Canada’s Gazette, Part 1 of 9. December 2017]
 
*[https://www.phuse.eu/documents//working-groups/data-transparency/phuse-comments-to-gazette-09dec2017-part-i-v10-19896.pdf PhUSE Data Transparency Working Group’s Comments on Canada’s Gazette, Part 1 of 9. December 2017]
 
* [https://www.phuse.eu/documents//working-groups/data-transparency/phuse-comments-to-health-canada-guidance-of-10apr2018-v10-19895.pdf PhUSE Data Transparency Working Group’s Comments on Health Canada’s DraftGuidance for the Implementation of the Public Release of Clinical Information of 10 April 2018.]
 
* [https://www.phuse.eu/documents//working-groups/data-transparency/phuse-comments-to-health-canada-guidance-of-10apr2018-v10-19895.pdf PhUSE Data Transparency Working Group’s Comments on Health Canada’s DraftGuidance for the Implementation of the Public Release of Clinical Information of 10 April 2018.]
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*[https://www.phusewiki.org/wiki/images/d/d9/PhUSE_DT_WG_-_FDA_Pilot_Review_Comments_-_v1.0.pdf PhUSE DT WG - FDA Pilot Review Comments - v1.0.pdf: “PhUSE Data Transparency Working Group’s Comments on FDA’s Clinical Data Summary Report Pilot Program - Federal Register / Vol. 84, No. 124 of Thursday, June 27, 2019”]
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*[https://www.phusewiki.org/docs/WorkingGroups/DataTransparency/PHUSE%20re-start%20of%20EMA%20Policy%200070%20Suggestions.pdf PHUSE re-start of EMA Policy 0070 Suggestions_20200117.pdf – “PHUSE Data Transparency Working Group’s Suggestions to EMA Policy 0070 Re-start – 17 January 2020]”
  
 
=Papers=
 
=Papers=
  
 
*[https://ebm.bmj.com/content/23/6/210 When to include clinical study reports and regulatory documents in systematic reviews]
 
*[https://ebm.bmj.com/content/23/6/210 When to include clinical study reports and regulatory documents in systematic reviews]

Latest revision as of 05:45, 14 February 2020


Project Overview

The PHUSE Data Transparency Working Group, as an active player in the field, reviews on regular basis a number of deliverables produced by other key stakeholders in the form of guidances, policies or articles. In particular, the PHUSE Data Transparency Working Group was invited to the EMA Policy 0070 Stakeholders meetings to comment on earlier version of the External Guidance.

In addition, the Working Group has had a collaboration with TransCelerate on the topic and the 2 organisations provided each other comments on respective deliverables.

The Working Group also provided comments to Health Canada on their respective policy and guidance that were available for public review. The Working Group had an opportunity to provide feedback to the Cochrane organisation on their paper 'Interim guidance on how to decide whether to include clinical study reports and other regulatory documents into Cochrane reviews'.

Project Leads & Members

For each deliverable to be reviewed, different working group members volunteer based on their interest. We do not try to align all the comments although all comments are discussed within the group of reviewers and we provide all comments that are received from different experts so that the authors can receive and assess different opinions.
Name Role Organization Email
Jean-Marc Ferran Project Lead PHUSE jean-marc.ferran@phuse.eu

Project Updates

The PHUSE Data Transparency Working Group is always interested to review other organisations' deliverables. Please get in touch with Project Lead if you would like us to review or give input to your work.


Project Activities

There are no current reviews taking place at the moment.

Deliverables

Papers