Data standards are routinely discussed within the life sciences industries today, and many research companies have been piloting the use of CDISC standards within their organization. CDISC (Clinical Data Interchange Standards Consortium) is composed of more than 250 companies that pay for the privilege to develop and establish industry standards for clinical data.
1 In addition to financial support, companies contribute their domain experts’ time to develop and support these data models.
The business case for standards is well-documented,2 but most biopharmaceutical companies have failed to push standardization beyond the pilot stage. These projects generally rely on several key individuals at each company, and ultimately depend on various manual processes for implementing the prescribed standards. That approach is not sustainable. And there are not enough well-trained experts to go around.
The successful operationalized implementation of standards requires the development of repeatable, scalable, and automated technical processes, and should apply technology specifically designed for the task at hand. While companies frequently try to configure a generic tool for this task, there is far more value in applying a fit-for-purpose data integration software solution. Such a solution will come predefined with the requisite CDISC data models and processes, and will be designed to readily handle the natural evolution of those models. This fit-for-purpose approach, almost by definition, implies a much more sustainable, operationalized approach. Rather than constantly tweak and administer customized CDISC approaches, research companies can instead focus on applying the CDISC standards in their daily business processes.
From a business process perspective, the CDISC standards have been difficult to operationalize because of the perceived “uniqueness” of each clinical trial. In many cases, standards fail to gain traction because individual projects are exempted. For some projects, exemptions make sense, but for a standards-based initiative, exemptions clearly run counter to the spirit of the program. In order to realize the well-established value of industry standards, companies have to fully embrace their use.
In early 2010, the FDA publicly suggested that “use of the CDISC standards, refined and developed as needed, will result in high-quality submissions that will be reviewed more quickly; as such, the likelihood of an approval on the first review cycle will increase.”3 In spite of such clear direction, exemptions remain commonplace and are fundamentally misaligned with the desire of biopharmaceutical companies to see their products quickly approved.
In many ways, a perfect storm is brewing with regard to the implementation of the CDISC standards. Pilot projects have shown success. Targeted solutions have been developed. Regulatory agencies are embracing their use. It is now up to researchers to take the next step in order to reap the benefits within their organizations.
References
1. Membership List. CDISC. Available at: http://www.cdisc.org/stuff/contentmgr/files/0/eb675f2d0e860fe53d5fb0d0a9d9a079/member_list/20100609_cdiscmembershiplist.pdf. Retrieved on July 13, 2010.
2. Business Case for Standards. CDISC. Available at: http://www.cdisc.org/business-case. Retrieved on July 13, 2010
3. Clear Messages from FDA CDER and CBER. CDISC. Available at: http://www.cdisc.org/fda-cber-cder. Retrieved on July 13, 2010.
About the Author
As a senior manager for SAS, David Handelsman is responsible for identifying and supporting those market opportunities where advanced analytics brings dramatic innovations and improvements to the business and science of the health and life sciences industries.
This news was published in Drug Discovery & Development magazine: Vol. 13, No. 6, July/August, 2010, p. 13.
