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English Speaking User Group Face to Face Meeting

Implementing CDISC Standards from Protocol to P-Value

10 December 2009

Hosted by Medidata Solutions at Brunel University Conference Centre, Uxbridge

The day saw 53 delegates attend from across UK, Germany, Switzerland and Ireland.  There was variety amongst those in attendance in their working disciplines, from Data Managers, Statistical Programmers and Medical Writers.  There were also Software Vendors in attendance and also presenting.

In comfortable facilities, attendees were greeted by Donald Paterson (Amgen) who had co-ordinated the day’s programme, and outlined the agenda.

The first talk was presented by Mark LeBlanc (Eisai) and Michael Auld (Eisai), “Fast Tracking multiple studies using SDTM and ADaM”, which was an honest assessment of the practicalities involved in delivering multiple studies and the benefits and disadvantages of preparing submission-ready data at an early stage of development.  This encouraged a lot of questions from the floor which carried over into tea/coffee and into the afternoon.

Second to speak was Lauren Shinaberry (PRA International), who expanded the issues raised in the first talk, “A CRO perspective on implementation of SDTM across multiple sponsors”.  She talked about the difficulties in understanding the needs of the client, explaining that they could be grouped into 3 types: CDISC-naive, CDISC-expert, and those that were somewhere in between these two groups (the majority).  Also there were often subtle differences between clients’ interpretations of the CDISC standards – which could present confusion internally when repeating the same tasks to different clients.

Next was Darren Weston (Novartis) who presented, “CDISC – Mapping new pathways for Novartis”.  The challenges of organising data for a submission using Oracle Life Sciences Hub and a suite of existing SAS macros was detailed but also it was shown that understanding and clarifying what is required from regulatory authorities was the most revealing.

Following lunch was a live demonstration from our hosts Medidata - and the theme of the day, “From protocol to p-value: ODM along the critical path”, presented by Vaishali Patel (Medidata), Doug Bain (Medidata) and David Smith (SAS Institute).  They demonstrated an integrated end-to-end system incorporating Medidata Rave, Medidata Designer and SAS Data Integration Studio.  They showed that by entering protocol design information into the system (e.g. schedule of assessments, CDASH terminology) this could create metadata and help automate the setup for data capture and constraint checking, and that the heart of the exchange was data in the CDISC ODM format.  A strategy of integrating standards at all stages of the process was promoted, and the idea of multi-skilling across disciplines using the various software packages also emerged.

The final part of the day was an informal round-table “Birds of a Feather” session, in which delegates could discuss further the presentations with the authors.

Presentations can be found in the CDISC Portal under the English Speaking User Group.