Antoine Regnault, Modus Outcomes’ Global Lead – Statistics, was a panel member of the SPIRIT-PRO consensus meeting that was held in Birmingham, UK on May 11-12, 2017.
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol.
The SPIRIT-PRO extension will provide guidance on the Patient-Reported Outcome content of clinical trial protocols. It is informed by different data sources (systematic review of published guidance, evaluations of over 200 clinical trial protocols, 2-round Delphi process and a stakeholder survey).
The consensus meeting involved about 30 experts from academia, regulatory agencies, industry, institutional agencies, and scientific journals and will lead to the publication of a checklist of specific PRO protocol items to be included in trial protocols and ethical reviews.
Modus Outcomes is proud to be part of this initiative and contribute to raising the quality standards for the demonstration of treatment benefits in terms of PRO in clinical trials.
More information on SPIRIT-PRO: http://www.birmingham.ac.uk/research/activity/mds/centres/cpror/research/spirit-pro.aspx
And on twitter: @CPROR_UoB #SPIRITPRO