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How Can We Accelerate Innovation with Standardization? Thoughts from the CDISC European Interchange

At Medidata, we pride ourselves on loving things that some may not consider cool—or maybe it’s just me!—and we love standards. Standards allow us to build software in a way that is instantly interoperable and allows us to create low maintenance integrations, both within our platform and externally. And so when some of my colleagues and I spent the last two days in the company of many people who think standards are cool, it was exceptionally thought-provoking.

The Clinical Data Interchange Standards Consortium (CDISC) Interchange in Stockholm, Sweden this week was packed with great presentations on the potential, importance and progress of standardization within our industry. It was fantastic to see the real difference CDISC has made over the years and to see that they are building relationships with other organizations that will help further drive progress. There were presentations on the application of existing standards and the value they have brought, including reminders that ultimately all this is for the good of real patients. For example, standardization allows the aggregation of data that can lead to discovery of new endpoints that truly impact the quality of life for real patients. There were also thought leadership presentations on the future of standards; I learned new words (“ontologies,” anyone?!) and was constantly reminded that as members of the standards community, we have an important part to play in their advances and developments. The other consistent message was that consensus-driven standardization is the right thing to do. This was the idea that really got me thinking.

It seems that the need for a new standard is partly driven by desperation—a realization that we are in a bit of a mess. The process of development of a consensus-based standard is then, by necessity, a long and slow process. And so we find ourselves in a bit of a bigger mess and with a mammoth task of implementing the standard and unraveling the already created mess.

As someone who works on software that aims to do things in a way that is “new, different and better,” this means often there isn’t a standard available for what I want to do. Thus, we are unlikely to gain consensus, as the process is unfamiliar to most.

This raises the following question: Is there a way organizations like CDISC could be on the cutting edge? What can we do better to ensure they are as innovative as possible?

I’d love to hear your thoughts and comments, especially if you were at the interchange!

More about Michelle Marlborough

For more on the CDISC European Interchange, check out this video from guest blogger Sonia Araujo following her presentation at the Clinical Data Acquisition Standards Harmonization (CDASH) track, along with Rhonda Facile from CDISC and Gary Walker from Quintiles. Sonia, Rhonda and Gary talk about the CDASH E2B project and share their impressions of the first day.

At Medidata, we pride ourselves on loving things that some may not consider cool—or maybe it’s just me!—and we love standards. Standards allow us to build software in a way that is instantly interoperable and allows us to create low maintenance integrations, both within our platform and externally. And so when some of my colleagues and I spent the last two days in the company of many people who think standards are cool, it was exceptionally thought-provoking.

The Clinical Data Interchange Standards Consortium (CDISC) Interchange in Stockholm, Sweden this week was packed with great presentations on the potential, importance and progress of standardization within our industry. It was fantastic to see the real difference CDISC has made over the years and to see that they are building relationships with other organizations that will help further drive progress. There were presentations on the application of existing standards and the value they have brought, including reminders that ultimately all this is for the good of real patients. For example, standardization allows the aggregation of data that can lead to discovery of new endpoints that truly impact the quality of life for real patients. There were also thought leadership presentations on the future of standards; I learned new words (“ontologies,” anyone?!) and was constantly reminded that as members of the standards community, we have an important part to play in their advances and developments. The other consistent message was that consensus-driven standardization is the right thing to do. This was the idea that really got me thinking.

It seems that the need for a new standard is partly driven by desperation—a realization that we are in a bit of a mess. The process of development of a consensus-based standard is then, by necessity, a long and slow process. And so we find ourselves in a bit of a bigger mess and with a mammoth task of implementing the standard and unraveling the already created mess.

As someone who works on software that aims to do things in a way that is “new, different and better,” this means often there isn’t a standard available for what I want to do. Thus, we are unlikely to gain consensus, as the process is unfamiliar to most.

This raises the following question: Is there a way organizations like CDISC could be on the cutting edge? What can we do better to ensure they are as innovative as possible?

I’d love to hear your thoughts and comments, especially if you were at the interchange!

More about Michelle Marlborough

For more on the CDISC European Interchange, check out this video from guest blogger Sonia Araujo following her presentation at the Clinical Data Acquisition Standards Harmonization (CDASH) track, along with Rhonda Facile from CDISC and Gary Walker from Quintiles. Sonia, Rhonda and Gary talk about the CDASH E2B project and share their impressions of the first day.