Progressing in the Complex but Critical World of Standardization

In theory, standardization sounds simple: CDISC develops the data standards, and companies follow the rules and the format for submitting their data sets. In reality, however, standardization means a lot more than simply datasets.

By Mark Tumelty, Manager Biometrics and CDISC, Life Sciences Business Process Services

Companies need to be thinking from study design about standardizing how they collect patient data, what the case report forms looks like, and how data gets entered, processed and moved into the standard format. And they need to be considering how those standardized datasets get rolled into reporting and summarizing data to enable time savings and cost efficiencies.

The biggest challenge companies usually run into is at the front end with data collection. Very often, companies don’t have the luxury of being able to simply change how the data looks if there is an entrenched case report form system or electronic data capture system in place. While there are systems that collect and store data as a Study Data Tabulation Model (SDTM) file, changing to those systems can be costly, time-consuming and resource-intensive in terms of retraining staff.

Another hurdle is having broader and deeper SDTM knowledge. It’s not just about making a dataset, it’s about following rules, parameters and guidelines to make the data presentable. It’s about making the data inside the datasets acceptable, which goes far beyond simple concepts such as variable names.

So how do you overcome these hurdles, given that SDTM is set to become mandatory – never mind the long-term benefits of having standardized data?

At the front end you can overcome the issue of not being able to collect data in an SDTM format by changing the values of your data when you collect it. It could be as simple as changing the date format in the stored database. This might sound insignificant but think about the number of times sites enter dates and how often those dates are reviewed. Changing the format to adhere to SDTM can eliminate a lot of work later on. At a more complex level, controlled terminology [e.g., answers to adverse event (AE) severity], needs to be presented in a particular way. Storing data in the way CDISC requires will be easier for companies in the long run than having to convert or map later on.

These seemingly simple changes not only help to streamline the SDTM process but ultimately improve traceability, since the SDTM data that has to be submitted to the regulators can now be linked back to the raw data. From the point of view of one record, that’s probably not terribly meaningful, but consider that there are tens of thousands of AE and lab records, and the value of changing the format at the start becomes clear.

As I said at the outset, the problem is that standardization is far from simple. Standardizing the data format during collection to be CDISC-compliant requires knowing and understanding the CDISC and SDTM guidelines. The trouble with that is CDISC is not a static environment. CDISC works continually with agencies globally to develop new ways to standardize data.

Recently, for example, the focus has been on standardizing questionnaires, such as those for quality of life. Today, regardless of the therapeutic area, patients are asked questions such as “how are you feeling today” and “are you able to get around.” The way the data from those questionnaires is collected and reported has changed, but how do companies keep up with those changes?

As my colleague Jeanna Radick explained in her recent blog, there are many grey areas around how the data is presented, and dealing with those requires experience.

Life sciences companies have a lot to deal with when managing clinical trial data; having to continually check CDISC, follow meeting notes, and stay on top of CDISC announcements is time consuming and adds to an already busy work schedule. Working with CDISC experts who not only follow developments but are involved with these developments through membership on advisory councils and frontline expertise relieves the challenge of CDISC compliance. As a result, companies will not only be in a better position to meet mandatory standardization, but realize the broader benefits of greater efficiency and cost savings.

For more information, please contact us.


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