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Strength Through Collaboration

In this information age, every industry is discovering the best ways to deploy technology to improve its functions. CDISC is no different, and is busy working with partners to find new ways to access and leverage clinical data more efficiently.

For many of us, it may be hard to believe that the European CDISC Coordinating Committee (E3C) has been in place for 10 years now, and that CDISC has been around even longer. Although CDISC began in 1997, focusing primarily on standards to meet the needs of the US Food and Drug Administration (FDA), it has gained a much wider scope than that over the past decade.The European CDISC Interchanges seem to have a broader interest in the entire suite of CDISC standards and the potential for end-to-end solutions that will streamline the collection and transfer of clinical data, leaving the industry better able to focus on the research, discovery and safety of new treatments. In other words, CDISC is not just about the FDA, and their latest activities and strategies for the future reflect this. In the past year we’ve seen a growth in the interest of shared metadata repositories and common semantics for data elements that will pave the way for better interoperability between computer systems.The capabilities that today’s technologies offer have yet to be fully realised in our industry. Are we finally poised to catch up to the possibilities that technology offers us? That’s the vision CDISC is working towards.

The Changing Role of Technology in Society

We’ve become accustomed to having data readily available even for the most mundane things – whether through an application on our phone that tells us what restaurants are near by; to using social online communities to find out what our friends are doing today; or laptops or tablet computers becoming commonplace features in doctors’ examination rooms.The way we collect and use data for our research (academics as well as in clinical settings) seems rather archaic by comparison.We can access trends as to what people are putting into internet search engines, or the online news stories that are getting the most interest, yet our clinical data is nowhere near being this accessible or being leveraged to the same degree as these everyday tasks.The public are growing used to having a huge amount of data at their fingertips, without needing to understand the intricacies behind the scenes that allow all these data from different sources to be shared.As the realisation of technological possibilities has come to the forefront in our daily lives,we grow more comfortable with the idea of applying these same technologies to the pharmaceutical industry.

Content Versus Exchange

CDISC standards have historically been divided into content standards, such as SEND, SDTM, ADaM and Controlled Terminology to exchange standards, such as ODM and Define.xml. In the early years, CDISC Interchanges were heavily attended by the community of clinical programmers, data managers and biostatisticians, whose work were most directly linked to the CDISC content standards. Recent years have seen the balance shift and the exchange standards are now receiving an equal, if not greater, amount of attention at Interchanges.

The content community is looking for CDISC to provide more guidance around mapping data to SDTM, practical examples of ADaM implementation, clearer definition of the rules for ensuring CDASH forms, SDTM datasets and ADaM datasets comply with the standard, and would like more therapeutic area standards.

The exchange community is more likely to include software vendors, clinical informatics and IT.This group is asking for more support from CDISC on the integration of various data systems, such as linking electronic health records (EHRs) to clinical data management or EDC systems.They are interested in complex data types, transfer protocols, and the Integrating Healthcare Enterprise (IHE) initiative’s retrieve form for data capture (RFD).

These two groups are not mutually exclusive, and as both types of standards mature, they are becoming more intricately linked.Using the example of having a phone app to help you choose a restaurant, the content community are equivalent to the users of the restaurant app.They may not necessarily be concerned with how the phone gets the information it uses to make the recommendation, or how it knows which ones are closest to your current location, but they do understand what they want to do with that information and how they would like to see it work in future versions.The exchange community are equivalent to the developers of the phone app.They are the ones concerned with how information is getting into the software and what needs to be going on behind the scenes for the user to get what they need out of it.

Strength through Collaboration

Never has the CDISC motto of “strength through collaboration”been more appropriate than now.This applies to the work CDISC is doing with other Standards Development Organizations (SDOs), as well as bridging the worlds of clinical research and clinical care. For any group effort to be successful, there must be a common vocabulary to allow agreement on what you’re talking about. This becomes even more important when the vocabulary each party is using seems to have the same definitions in it.

You need to be careful not to make assumptions about what at first glance looks to be the same thing. For example, is a blood pressure measurement in a patient’s electronic health record the same as what an EDC system will expect it to be for a specific study? Does one system limit the definition of a blood pressure measurement to only one taken while the subject was seated? What other pieces of information are implicit in one system or community, that need to be explicitly stated in another?

Once everyone agrees on the definitions used, how do you make sure you can communicate all these common semantic elements to others? Like a dictionary people use to look up what a word or phrase means, common metadata repositories can be used to store all these agreed-upon definitions.This is where the CDISC Shared Health and Clinical Research Electronic library (SHARE) project comes into the picture.This is one of the newer CDISC activities, which in the simplest terms, gets us away from using spreadsheets to list definitions and instead introduces a wiki-like interface that is far more flexible and scalable, while being both human user-friendly and machine-readable.This is where we can start storing and referencing the language for our collaborations.

These common metadata elements can then be used to create clinical trial repositories (CTRs).The CTRs in turn will allow the clinical user community access to the information they need in order to analyse their data and run their trials effectively. For these efforts to be successful, input required is from therapeutic area experts to explain their needs and definitions, combined with the technical input to translate those definitions and requirements into a flexible, machine-readable metadata definition.

What’s Next for CDISC?

CDISC as an organisation is facing an unprecedented number of global opportunities to play a part in realising the vision of accessing and leveraging clinical data in powerful ways.There is no shortage of prospects, including several key partnerships and alliances with professional organisations, regulatory authorities, healthcare IT groups and academia. Interest in CDISC from North America and Europe is being joined by a growing presence in Asia.

A look at the CDISC website is the best way to get the latest update on how the clinical content experts are working with their IT counterparts.No doubt in the time between writing this article and its publishing, there will be a whole new list of accomplishments on the site. Some recent examples are:

  • CDISC is part of the Joint Initiative Council (JIC) on SDO Global Health Informatics that is focused on trying to coordinate all the different activities in progress by various groups working on health informatics to avoid diverging standards and counterproductive efforts between these initiatives
  • At the DIA Annual Meeting in June 2011, the Healthcare Information and Management Systems Society (HIMSS) Interoperability Showcase gave us a peek at the possibilities for linking EHRs and clinical research data systems. Part of its success was due to the alliance between CDISC IHE initiative
  • The Innovative Medicines Initiative has been working on a Memorandum of Understanding with CDISC to use CDISC standards for their Knowledge Management.There exists the opportunity to develop new CDISC standards to help support the vision of both
  • CDISC and the Critical Path Initiative are looking to build upon the success of the Alzheimer’s disease clinical trial database by turning their attention to other diseases such as Huntington’s disease, multiple sclerosis, diabetes and other diseases that the FDA has identified as priorities with respect to their impact on public health

Is This the Right Direction for CDISC to Take?

So what is the point of working towards the integration of EHRs and research? Why do we need to spend time defining every item of data in excruciating detail? What will these clinical trial repositories do for research? It’s important not to lose sight of the purpose for all this work. Translational medicine is a big factor in the direction our industry is taking, and with it comes the need for removing barriers between multiple disciplines. The more robust the data available to them, the better-equipped researchers and clinicians can be in making important decisions that directly impact the lives of their patients. Simply combining data in clinical trial repositories and having it in a consistent format and accessible location isn’t enough. As an industry, we need to be changing the way we think about our clinical trial data.We need to be smarter about using the vast amount of information available in order to make more efficient decisions without compromising quality or patient safety.

Increasingly the work that is being done by CDISC is integral with computer systems design concepts, and may be very different from what the traditional data management and biostatistics community are familiar with. Ultimately, the efforts of CDISC and its many partnerships will mean that the users interested in the content will not need to have the IT data exchange expertise to link all their data together.The unique position of CDISC allows it to provide content to collaborative efforts with groups representing the more technical content expertise.However, this also means that finding volunteers to participate in these activities is a different pool to data managers and statisticians. CDISC needs to support effective innovation and needs to do this in a way that makes sense to the clinical research community – not just the IT community.No organisation can extend itself to an unlimited number of activities, and an organisation dependent upon volunteers to provide the resources to move projects forward has its own unique set of limitations. The ability of CDISC to meet the needs of its membership is directly linked to the willingness of subject matter experts to donate their time and effort to developing and reviewing standards that support their goals.

Conclusion

At the core of the most important discussions being held by CDISC leadership is the question “Where can CDISC meet the needs of our global members most effectively and responsibly?” It’s critical for CDISC leadership to be clear on the areas where CDISC can provide the most useful contributions since the requests and opportunities for alliances can be overwhelming.

It is a testament to the success of CDISC that there is such demand for more standards and more guidance on implementation of existing standards. I also believe that CDISC should surely continue to lead the way on representing the needs of the clinical research community in each of their collaborations with other groups so that we can realise the goal of integrated healthcare and research. When subjects agree to participate in our research, we have an obligation not to waste the data they have generously allowed us to collect. In this information age, clinical trial repositories are the keys to ensuring we are making the most informed decisions possible with respect to patient safety and can allow us to identify when a study is not of benefit to the participants. If we aren’t leveraging all the information available to us, we are falling short of our responsibility to our trial participants.


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Lauren Shinaberry is Director of Global Standards & Libraries for PRA. Lauren holds a degree in Mechanical Engineering with a specialisation in Biomechanics. She has over 14 years of experience in clinical research and is the 2011 Chair-elect of the CDISC Advisory Board. Lauren is also part of the CDASH leadership team and is on contract by CDISC to provide public training on CDASH and SDTM on their behalf. Email: endpoints@praintl.com
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Lauren Shinaberry
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