Clinical Data Interchange Standards For Medical Devices — Lessons Learned From Pharma/Biotech

The healthcare industry, as well as regulatory bodies, has been hard at work in the standardization of clinical trial data. The need for data transparency, traceability, and auditability has continued to increase, in line with the cost of studies and the amount of data submitted to the FDA. As a result, much progress has been made in the past decade in creating standards to ease data exchange and interoperability as well as speed up the regulatory review process.

Pharmaceutical companies started adopting CDISC (Clinical Data Interchange Standards Consortium) standards, such as SDTM, in 2004. Although medical device companies may have until the next MDUFA to comply with CDISC requirements, several companies are already implementing the medical device standards. A pilot project is underway by CDRH to evaluate CDISC standards for medical devices.

Thus, it is only a matter of time before medical device companies reach the goal of submitting data in CDISC standards to the FDA. Which best practices can pharmaceutical companies share when implementing CDISC standards? What are the vast differences between pharma/biotech and medical device companies when it comes to adopting and converting clinical data to CDISC standards? These are some of the questions addressed in this roundtable Q&A involving both medical device and pharmaceutical experts.