Over the past 15 years, FDA and industry have aligned to make significant progress in promoting, adopting, and developing data standards to align with FDA’s goal of accelerating the regulatory review process. Data standards enable all scientific disciplines to understand the safety & efficacy of a product more efficiently in making a regulatory determination for approval. The emergence of standards technology has become prevalent as well as the enforcement of data exchange standards in submitting clinical and non-clinical data. While data standards efforts continue, limitations involving traceability, interoperability, and linkage of data from collection through analysis remain.
Standards organizations such as CDISC, HL7, and other key standards organizations have realized the legacy paradigm of data standards cannot support the future operational needs of the industry and regulatory review process which inhibits major steps forward. HL7 has engaged in a new approach to exchange standards over the last 3 years implementing FHIR, an innovative exchange framework focused on flexibility and rapid implementation. Similarly, CDISC has initiated an ambitious pilot project, namely CDISC360 to reinvent standards implementation from beginning to end with the goal of providing standards that are linked to enable automation.
FDA and industry must work together to understand and support the need to move to a new approach for implementing and consuming data standards in order to fully realize their potential. This approach must also be balanced with the need to execute, operationalize, and iterate as necessary.
d-wise is uniquely positioned to support your organizations diverse data standards needs based on its pedigree in combining extensive standards implementation experience and deep clinical data technology expertise to optimize the use of standards processes and tools. Let us know if we can help!