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Abstract:
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Data in CDISC format will soon be required for all regulatory submissions. A transition period from historical processes to new processes accommodating CDISC is in progress. Internal processes and procedures need to be updated so results meet submission standards, and statisticians are playing a key role in the implementation process. Three common reasons are: (1) not all projects will result in submission, (2) submission standards are not meant to support day-to-day activities when conducting a clinical trial, and (3) implementation can be expensive. Implementing CDISC for use on day-to-day activities is inherently challenging as missing and incomplete data often result in complex programming rules. Some companies have been successful in the transition to CDISC, but many think significant efforts are required to adopt such standards when they are not always necessary. Furthermore, depending on the progress within a drug development process, the expense may not yet be justifiable. The focus of this roundtable discussion is to highlight some of the challenges and discuss potential solutions to these and other challenges associated with implementing CDISC standards.
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