Autumn 2006
Senior CDM Forum – A Standardised Future for CDM
27th September 2006, Novartis Foundation, London
On Wednesday, 27th September, 20 delegates assembled at the Novartis Foundation in Portland Place for the latest ACDM Senior Forum – A Standardised Future for CDM.
The first presentation, "Why, What and How to Standardise" was given by Jen Rowell from Roche. Jen quickly explained the logical reasons for "Why" – to promote data integration, increase efficiency, reduce costs, facilitate data interchange (e.g. between CRO<->Pharma; Pharma<->regulatory authority; etc), allow aggregation of common data to allow further exploitation of our data assets and, perhaps less often appreciated, to allow us to focus on the "truly novel" aspects of the clinical trial. Additionally, standards can often act as a stimulus for innovation and continuous improvement by reviewing metrics associated with the use of standards. The use of standards also facilitates a more distributed work pattern, so allowing better use of limited in-house Pharma resources and/or the use of CROs.
Moving on to "What" to standardise, of course there are the usual standard CRF modules, leading to a more standardised database build, standard data validation checks/programming, standard analysis and reporting. Also, there will be standard processes, for example standard coding conventions, data entry conventions, etc. Jen noted that standards are usually implemented at four different levels – generic, e.g. CDISC standards; therapeutic; project; study.
"How" to standardise is the more troublesome part. One method used by Roche is the implementation of study "de-briefs" at key study milestones which allow identification of areas for improvement and/or areas which need better standardisation. Individuals are also encouraged to submit their own suggestions for improvement.
Jen described two main processes used to determine standards needed:
Reactive – reacting to process and deliverables
Proactive – knowledge sharing from external sources and/or study de-briefs.
She went on to highlight particular difficulties with establishing standards as being getting buy-in from stakeholders for the resources needed, developing a governance model to encompass the whole lifecycle of the standards and also ensuring that standards developed are actually used within the organisation. However, the pressure from regulatory agencies is increasing, so the use of standards will be increasingly important for us all.
The next presentation was given by Linda Talley from Lilly. As Linda is based in the US, we were all delighted that she had offered to come and speak at the Forum. Linda's presentation gave us all a very enlightening insight into all the current standards under development that may affect our CDM work.
Not surprisingly, CDISC was the main standard under discussion. Linda noted that the FDA draft guideline on Study Data Specifications notes that the CDISC Standard Data Tabulation Model (SDTM) can be used for clinical trial submission data and that the FDA is currently exploring regulatory approaches to require the use of the STDM standard for regulatory submissions. In fact, Lester M. Crawford, Acting FDA Commissioner was quoted as having stated "...Having the data presented in a standard structure will improve FDA's ability to evaluate the data and help speed new discoveries to the public."
Lilly has gone to great lengths to implement data standards and has been very closely involved with the development of CDISC standards.
Linda explained the definition of standard data variables within Lilly which includes attributes such as:
Naming conventions
Coding/de-coding lists
Data collection format
Definitions of words/terms
Business rules
Standardised scoring information
Safety and common data standards have been developed, as well as therapeutic area standards. It was emphasised that this process has taken a long time and considerable resource to achieve.
Finally, Linda reiterated the need for advocacy to communicate, educate and promote the use of standards.
After these initial two presentations, we embarked on two workshops which encouraged us to look at the challenges CROs face when working with numerous Pharma "standards" and emphasised to us all that the implementation of CDISC will not see us all immediately using one common standard. It was commented that there are currently as many different CDISC "standards" as there are Pharmaceutical companies trying to implement CDISC!
In the final presentation of the day, Jen Rowell described the implementation of a change control process for standards. Jen emphasised the need to consider the whole life cycle of a standard through ownership, governance, evaluation and change control. A Governance Board for standards is often multi-functional and change control needs to involve all members of such a board. Clear guidance is needed for the use of standards, including when they become effective, when they should be used and by whom, what flexibility is allowable (and some flexibility is essential to ensure standards actually will be used) and how the standards should be used. A process for monitoring use of and requests for deviations from the standards is essential, as also is a described mechanism for providing feedback. Formal feedback should be solicited from users on a regular basis with a formal review process in place to detail who reviews and when. A process should also be in place to request changes as required; although it was recommended that implementation of changes should be limited to specific time points to ensure a more controlled changeover process. Before any changes can be implemented, it is essential that the potential impact of the changes on resource, schedule, cost, quality and performance is assessed. If the Governance Board is in agreement to effect the change, then a formal acceptance process should be in place with full version control. Finally, of course, a retirement process should also be implemented.
The afternoon concluded with a review of our objectives to ensure all had been covered. I think we all agreed that they had been and that the afternoon had been both enjoyable and informative. We then all retired to the dining room for a standard-sized glass of wine before the evening meal that was up to the usual delicious standard at the Novartis Foundation!
Some feedback from delegates
It was useful to hear others perspectives on all aspects of standardisation.
I found the session very useful as I work with CROs from a Pharma perspective at the present so it was useful to hear the CRO perspective.
Very useful, the two presenters were excellent.
Very useful source of information.
Good open discussion which was encouraged by speakers.
Very informative, I never actually knew some of this stuff!
The ACDM Senior Forum
The ACDM Senior Forum is open to all ACDM members who have at least 5 years experience in Clinical Data Management, plus some line and/or project management experience.
If you are interested in joining the mailing list for the Senior Forum, please email enclosing a copy of your curriculum vitae or details of your experience/role within CDM.
Gill Lawrence,