The fourth annual CDISC international interchange conference took place in the North Bethesda hotel and conference center starting on Monday October 1st 2007. Monday included a work shop on “Implementation of C
DISC Standards End-to-End” and also a course on the ADaM data model which specifically deals with analysis files. However, the actual conference really started on Tuesday morning when the opening session started at 8:30am.
Overview
Opening Session
During the opening sessions, members of the board of directors were introduced. They then proceeded to give updates on the status of the various standards. David Hardison presented the "State of the CDISC Union". Some of the team members included people su
ch as David Hardison (Chair) and Rebecca Kish (CEO CDISC).
The discussion detailed the adoption of CDISC standards and how this was gaining global acceptance. CDISC was founded by Rebecca ten years ago and now it has grown to over 200 members. This ranged from biop
harmaceutical, academic research and technology vendors. The community is very active including members in Europe and Japan.
The members touted the adoption through the numbers of downloads of the open standard which has now reached 10,290 downloads. This is a 10 fold increase this year as compared to previous years. The education courses have expanded to over 50 courses and CDI
SC has started a "vLearning" program which you can attend virtually on the computer.
Standards Update
After giving a status to CDISC as a whole, the session switched over to individual team leaders who gave an update on each CDISC sub-team. CDISC is organized by its various initiatives. Some of these correl
ate to the CDISC standard models while other efforts are in attempts to "harmonize" or synchronize with other standard groups such as HL7. Team members then came up one at a time to describe the mission of each volunteer group and then describe the status
of their projects.
>- Who has access to the clinical trials data?
- What access control of firewall is put into place?
- What is source data? This was later answered as the first instance when the data is captured.
- Who is responsible? In many ins
tances, it is the clinical investigator. - Data Audit issues. This covers who has control of the data and responsible to keep its integrity.
It was explained that the regulations on CFR Part 1
1 is showing it age since it was established in 2003. It is currently going through review and is being "retooled". There will be additional ruling coming out soon relating to this regulation.
SDTM Presentations
There were several presentations from managers from different companies which provided lessons learned. I attended a presented by Gail Stoner from Centocor Research and Development entitled "Potholes and Detours on the Road to SDTM". She emphasizes the imp
ortance of defining a clear process which included training. The analogy used was a road trip so the training provides for a smooth route since it provided "local experts". She was able to establish a functional work flow in her group by writing down all m
ethodologies or conventions that was established. For example, she establishes the proper sequence variables and key variables. The process includes everything from defining the specification, developing the SAS programs according to these specifications w
hich then create the SDTM datasets. From this, she documents the define.xml file.
>
Some of the lessons learned from the entire process included:
- Allow time for developing a process
- Write things down when you decided upon a process
- Establish quality control process
- Discuss and resolve issues among groups
>
The presentation in which I thought had the most useful information in terms of sharing with users experiences on considerations of converting legacy data to SDTM was a presentation by Sandra Minjoe from Genentech entitled "Technical Considerations for End
-to-End Conversion of Legacy Data to SDTM and ADaM".
Sandra explained how her group had explored various different approaches before concluded on a recommended method. The conversion process to SDTM included all the domains along with controlled terminology. In this case, she started out with the raw oper
ational data. If the data was "raw" and not manipulated, that would be the most optimal.
SDTM was more standardized relative to ADaM. The development of the scripts l
ed to an automated way of generating the transformation to SDTM. However, the conversion to ADaM had to be done manually.
>
There were two approaches that were explored. The first approach was to have the source data used to create both the SDTM and ADaM. The second approach is to transform the source data to SDTM and then use S
DTM to create ADaM data. There is no strict guidelines specifying which is the best way. Sandra concluded that the second method was better since there would be less reconciliation between SDTM and ADaM in the event that they have different derivation algo
rithms from the same source. The validation efforts used included using PROC FREQ and PROC MEANS of the data to see the data in aggregate form. The end resulting SDTM and ADaM data were compared against the legacy data to ensure that the transformation did
not alter the values.
Some of the considerations that Sandra concluded after her experience were to use external expert help where it is needed. Even though internal team members may not have the expertise yet, it is useful to develop CDISC expertise as part of the process.
Rather than performing the task manually, she recommended to use automated SDTM conversion tools. The conversion starts from source -> SDTM -> ADaM.
I also attended a presentation by Robert Stemplinger of ICON Clinical Research entitled "Case Study: Preparation of Submission Data Sets Using SDTM, ADaM, and Define.xml for Study in Generalized Anxiety Dis
order". In Robert's implementation, he used SDTM 3.1.1 including producing the ADaM and define.xml. One of the interesting points which he pointed out was the amount of time it took to develop the transformation specifications for his conversion project. T
his took over 120 hours. This was much more than he had expected. He did this on a spreadsheet as one of the first steps in his planned approach.
> The process which Robert defined was not very much different from that of Sandra's. He started out by defining the transformation specification from the source data coming from the operational database containing the case report collected data. This
was then transformed to the standard structure of SDTM. The SDTM data would then be converted to ADaM. The case report forms would be re-annotated to reflect the newly transformed data. This would also match the data being documented in the define.xml. Fol
lowing the similar theme, Robert also recommended the use of tools to automate the process when possible. In his case, his team developed an internal tool which automated the creation of the define.xml. Robert said it did not generate 100% of the define.xm
l but it did automate many aspects which would otherwise take a lot of time. Other automation included things like the creation of a macro to convert dates to the standard ISO date format recommended from the guidelines.
Summary
This is the fourth year that the conference has taken place. The history of CDISC is still relatively young but I feel that things are beginning to mature. There are many attendees who are still learning about the models such as SDTM and ADaM but there are
beginning to be more people who have applied implementations and they are beginning to share their experiences. The lessons learned from these folks will provide insights and pave the way for the rest. There is more of a sense of inevitability as to when
the guidelines will become a regulation. The question seems no longer to be if but when. I was talking to Patty Gerend when she compared it to the Y2K. In Y2K, we knew exactly when it was going to happen. There was some technical substance to the date chan
ges but it was relatively small. In the CDISC case, we are still anticipating and not sure when it will be a regulation. We are aware however that the impact will be much more widely felt in the industry. In either case, CDISC standards appear to be more inevitable so the attendees of the conference were all learning how to best handle it when the day comes.
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