Monday, June 13, 2011

CDISC - Is there an alternative?

In the past few years, on several occasions, I have been asked the question on whether there's an alternative to CDISC?

The question comes from people from different backgrounds and affiliations: Large companies with their own well-established data standards, small companies with no internal standards and do not have the resource, knowledge or motivation to adopt such standards, companies who recognise the need of standards but feel that the CDISC standard is still changing constantly and prefer to wait, and companies which have been on the journey of CDISC adoption but have found that it was a rather bumpy ride. It seems that the majority who asked the question prefer to maintain the status quo - after all, we have managed to submit clinical data to FDA and obtain regulatory approvals without any data standards up to now, why should we go through the major upheaval and invest the money and time on adopting a standard that is still evolving?

The FDA Critical Path Opportunities List report has already mentioned CDISC SDTM (see item 44 in the report) as a data standard to streamline drug development and for exchange of healthcare information. In addition, the CDASH initiative in CDISC will help to promote the consensus on standards for case report forms (item 45 in the report). Development and implementation of such standards cannot be achieved overnight, but not embracing it means the risk of falling behind your competitors and greater difficulty in the path to regulatory submission and approval.

With the pressure on healthcare costs, outsourcing and offshoring seem to be the way forward to reduce costs. However, I believe that efficiency gain by the implementation of standards at various stages of the clinical trial process will drive the cost down also. For a sponsor, while you can create your own "alternative" standards and insist on all CROs to follow it, you need the resource to maintain such standards anyway and you would lose out on the leverage you can get from CROs that are familiar with the CDISC standards. There is a cost associated with the implementation of CDISC standards initially, and this investment is only worthwhile if you have a long-term vision and commitment to the implementation and adoption of standards. Of course when and how you implement CDISC will be dependent on your own circumstances, and you will have to decide the choices of CDISC standards at various stages e.g. you would probably not want to convert everything to CDISC from your legacy company-specific standard if you are just about to submit your drug to the FDA in the next few months (unless the FDA has asked you to provide the data in CDISC SDTM format).

When there are multiple standards, one always comes up trump - remember the good old days of VHS vs Betamax video tapes (for those old enough to even remember video tapes), or more recently blu-ray vs HD-DVD discs? As far as I am aware, there is not another standard that competes with CDISC currently, and even if there is, it will have a pretty high hurdle if it is to come out on top of CDISC, as it does not only have to demonstrate that it has a distinct advantage over CDISC, but it will have to compete with the large number of CDISC followers to gain acceptance.

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