CDISC: Increasing Connectivity, Interoperability and Communication

Rebecca Daniels Kush, Ph.D. is a Founder and the current President and CEO of CDISC, speaks to  Pharma IQ, about how eSource guidance is generating a lot of discussion and opportunity, improving e-submissions, making standards more accessible and how to better link healthcare and research.

Pharma IQ: What do you think are the top 3 new guidelines/regulations that are likely to impact/ be key areas for discussion amongst pharma/bio companies in 2011/2012?

R Kush: So key guidances and regulations that will impact our industry from my perspective—one of them would be the source guidance that was issued in draft form the end of last year, and comments were due in early April, and I think this is bringing a lot of discussion around the industry on how to use electronic source such as e-diaries or ehr’s for research purposes.  And that’s already generating a lot of discussion and a lot of opportunity.  There’s also, I wouldn’t call it a guidance, but it’s a set of issues that FDA Seider and Seiber have identified with people maybe not understanding how to provide their submissions in terms of the data.  So they came out with an issues list and also the resolution of those issues and how they would like to see data in the future.  So that is, I guess, an addendum on to the specifications of their final guidance around e-submissions and how they want to see data specifications so they can review the submissions faster and better and with higher quality.  And, of course, I’d like to see a regulation around the use of standards, but I’m not sure when that’s coming.

Pharma IQ: What are CDISC’s top priorities in the next 12 months?

R Kush: The top priorities for CDISC were discussed, actually, at the board meeting that we had in April in Europe in Brussels, and the three top items that the board of directors would like to see CDISC work on in terms of strategic themes would be first to be around the development of therapeutic-area standards.  So, now that we have the core set of CDISC standards, we’re trying to augment those with new domains around therapeutic areas.  And we’re looking at how to improve that process so that we can do that faster; and yet, end up with a robust set of standards that has a lot of input and consensus-based standards and input from around the globe.  So, developing therapeutic-area standards and improving the process around those is really a key one.  We are also proceeding with something we call SHARE, which is the Shared Health And Research Electronic Library, and it’s a way to allow the standards to be more accessible, and to really refine the standards in a way that everyone can use them.  And as a repository where all the standards will be found, an electronic repository.

And the other one would be proceeding with our healthcare-link initiative, which is to better link healthcare and research.  And what we’re trying to do is get a learning healthcare system so that if you provide research data, that we can more rapidly go back and inform healthcare.  And that’s a goal of the people in [unclear] national coordinator and some of the initiatives in Europe and around the globe.  So, we actually were excited to do the Interoperability Showcase here to show what can be done today in terms of using ehr’s for research, or electronic medical records, whatever you want to call them.  But we can use them for research today.

Pharma IQ: Any developments that have happened in the last year that you are keen to share?

R Kush: You wanted to know some things about a new development that I might want to share that CDISC has been working on.  And, from my perspective, one of the exciting things that we can offer now is that I’ve been working since 2002, when we started the protocol team, to develop a protocol standard.  And we have a protocol standard; it was launched as part of the bridge model, a UML model last, early last year.  But a lot of medical writers and people who need to use a protocol standard can’t work with a UML model.  That’s for IT people to work with and it helps develop tools.  So, we’re working on trying to come out with a way to bring medical writers into being able to use a protocol standard to help them develop protocols efficiently, and yet, to allow them to do whatever they want with the protocol design.  We’re not trying to inhibit any kind of creativity.  So, we’ve come out, this just next week, we’ll launch an extension of our operational data model that will support study design and the protocol team is working on this template or an implementation aid for people to use that standard.

Pharma IQ:
What are the benefits of CDISC standards in promoting and improving data quality and efficiency in data review?

R Kush: The FDA reviewers would like to see data in a standard format because if it comes in a non-standard format, they spend precious hours trying to understand what they received, how to work with the data, how they can review it; and if they get the data in a standard format, they can use very sophisticated tools to assist them in their reviews, they can start the review faster, and they can do a more efficient, higher-quality review.  And so, that’s why they’re working with us to make sure people implement the standards when they provide the data in their submissions and also to make sure that they follow the standard in a way that people intended it to be followed.

Pharma IQ: How do you think the clinical data manager’s role will be defined in an automated e-future?          

R Kush: The data manager’s role in the future in terms of what I do and standards—data managers understand data standards and the value, there’s no question there, so do statisticians--but to me, in this environment, they have the opportunity to influence the way that they’re implemented up front; to help people understand how to implement them in the beginning, because that’s where the efficiencies for those who do clinical studies come in, as if you implement the standards up front and so that’s an opportunity for them.  And to me, it allows them to do more science and more meaningful tasks rather than feel like their role is just cleaning up dirty data.

Interview conducted by Andrea Charles.


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