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What Should be the Next Great CDISC Standard?

I was listening to an Adam Carolla podcast this morning, and he was talking about coffee. His discussion about coffee prompted me to start a comparison to CDISC standards. Adam thought that the federal government should mandate coffee makers to all have the feature that stops the drip process when the pot is removed, allowing us all that first cup without making a mess. This line of thought prompted Adam to wish for a mandate on beer bottle caps. Shouldn’t they all be twist off? Why do we have both twist off and pry off tops? Or, if there are two kinds of tops, shouldn’t they be identified by color or something to let us easily know how they work?

Although Adam never once mentioned the word ‘standards’ in his tirade, this is exactly what he is wishing for. This made me thankful for CDISC for giving us standards for submission data. I also think the government has enough to do, and the CDISC standards approach of pulling together industry experts to come to consensus is the right thing to do. Can’t the beer makers all get together and come up with something? Isn’t it amazing to think that we, in the highly competitive pharmaceutical industry have pulled this off?

The data that CDISC has standardized is a small piece in the clinical research process, and are many other areas where we could benefit from standards in our industry. I polled some partners and industry experts, and here are some thoughts:

  • Jennifer Price, Director of Clinical Solutions at BioClinica
    Edit Checks – I would like to see standard checks for every protocol such as ‘visit date out of window’, or CDISC standard ranges for temperature, height and weight that can be used as a starting point, requiring the data manager to come up with only protocol specific checks. We could start with all of the fields in the standard CDASH domains. We could give each check a unique edit check code that any vendor could use making it possible to pool edit check information to provide overall metric comparisons.
  • Christie Wolf, Project Director at Axio Research
    I’d like to see us expand the CDISC SDTM standards for lab data. The SDTM domains designed for laboratory results do not contain all the information that are contained in a good lab transfer. For instance, many lab range values are dependent on gender and age, so it is important to include this in the lab transfer so we can be certain there were no transcription errors on the lab labels. Ideally, lab transfer standards would use the CDISC SDTM standards as a starting point, and provide the option of adding additional variables as needed.

    Also, it would be really useful if we could find a way to standardize an indicator of whether data cleaning steps have been performed on the data. If I look up an AE record in my database, I can quickly tell if it’s been coded, but I have no idea if this is the final coding, or if it is still undergoing medical review. In our case we write a lot of data monitoring committee reports, and we receive data from many different sources. If we were able to tell at the report generation level whether, say, an outlying data point has been confirmed by the site as correct, or has been questioned as a likely typo awaiting correction, we could pass that information along to the DMC committee.
  • Doug Bain, Partner at Soltex Consulting
    Over and above the critical improvement in the standardization of coffee machines and beer bottling…

    I would like to see edit check standards in CDISC ODM. Currently, support for Ranges exist, but they are far too limited. The CDISC implementation of a clinical study in EDC typically consists of 25% eCRF design/development/test work and 75% edit check development/test work. CDISC standards currently help in tackling the 25%, but it is only proprietary standards that help address the 75% - bulk of the development effort.

    Related to this, and potentially more critically, I would like to see a simple mechanism for the CDISC ODM metadata to be linked and representable in CDISC SDTM. When building up a clinical data repository (CDR), the value of the data held in this repository is conditional on the awareness of the context in which the original data was captured. For example, If you were to look at a 1,000 QT intervals in a CDR , can any value really be gained without also considering the criteria applied to the subjects that exist in the CDR. The edit checking needs to be codified together with the inclusion/exclusion criteria. This will allow full mining of information that takes into account the circumstances of the repository population.

    I fully concur with Christie with regards to the status of data. Today – many EDC systems have the means to offer continuous feeds of data to a repository. Ideally that feed would be standards based, but, no standard exists for data status. Many systems have pending review, pending lock, locked etc. These states should be manifested in the data that is output. This probably mandates the need for a 3rd dimension in the current CDISC SDTM structure. This can be represented well in XML.
  • Colin G. Miller PhD FICR CSci, Senior Vice President, Medical Affairs, BioClinica
    It is sad when we are griping about beer bottles not being screw top. Mainly these are from outside the USA where a beer is well crafted and drunk out of a glass and not the bottle. While standards are vital, we also have to allow different uses and expectations. On the one hand we want standardization but this is taking standardization and government control too far – if this is a problem, just stick to the domestic light beers and all will have screw tops. Getting more serious in clinical trials, where we have need for ensuring standards, the CDISC standards are an excellent combination to allow for the flavors while providing and excellent framework for standardization. In imaging, the so called DICOM standard has about 60 different flavors and many imaging equipment manufacturers still have their own proprietary format. Therefore a CDISC imaging standard would be really helpful.

And there you have it… several industry experts thoughts on areas where we could benefit from additional ‘standards.’ What do you think? Have any additional ideas on the next great CDISC standard? Please share them with us in the comments section below.

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