Getting the most out of “new” clinical data sources: Clinical Study Reports (CSRs) and Patient Level Datasets (PLD)
Posted on 28 November 2016
Date: Wednesday 7th December 2016
Time: 2-4pm
Venue: Room ATB/035, Seebohm Rowntree Building, University of York
Presenters
Sally Hollis (Head of Statistical Consulting, Phastar and Honorary Professor of Clinical Trials, University of Manchester) and Rebecca Sudlow (Global Lead Patient Level Sharing, Roche UK) are experienced drug development statisticians. They are members of the EFSPI (European Federation of Statisticians in the Pharmaceutical Industry) Data Sharing Working Group. This is a group of experienced clinical trial statisticians (from both industry and academia) who have first-hand knowledge of generating clinical study reports and patient level datasets that are used in regulatory submissions. All have a specific interest in the opportunities and challenges generated by sharing with external researchers.
Abstract
The continuing evolution in clinical trial data transparency is opening up new information sources for use in systematic reviews and researchers will need to gain an understanding of these.
The intent of this session is to provide an overview of these new data sources and how they can be accessed. As the presenters are from industry and have themselves contributed to the writing of clinical study reports and the generation of patient level datasets, they will be able to provide some insights into the “behind the scenes” processes involved. This will include how clinical study reports are prepared and the challenges around patient protection when documents and datasets are shared widely. This context will be useful when working with this type of information.
The following topics will be addressed:
- Should I be using the Clinical Study Report (CSR) or Patient Level Datasets (PLD)?
- How do I know what’s available?
- How do I get hold of CSRs or PLD?
The session will be a mixture of presentations and question and answer opportunities.
Please contact susan.sutton@york.ac.uk to book a place.