Adoption of data standards in clinical trials is not only required for regulatory submissions but also useful for maximizing the impact of clinical studies. The Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that creates and communicates standards supporting the acquisition, exchange, submission, and archive of data for biopharmaceutical product development. Developed in collaboration with global experts, the CDISC standards seek to make clinical data easier to understand and interpret, even for those who are not directly involved in the clinical study.
While CDISC standards can be applied to all phases of clinical development, compliance with the standards is only mandatory for submissions to the U.S. Food and Drug Administration (FDA) and other regulatory agencies that require it. In this article, we discuss CDISC standards, explore their benefits and provide a framework for determining when to apply them in early-phase clinical studies.
The main CDISC standards for clinical studies are Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). With limited exceptions, regulatory submissions to the U.S. Food and Drug Administration (FDA) for studies started after December 17, 2016, require data to be submitted in CDISC format. Any data collected during the study, including both Electronic Case Report Form (eCRF) and external data, must be converted using CDISC standards and provided in SDTM datasets.
These datasets are used as the source data for ADaM datasets which are, in turn, the source data for analyses documented in the Clinical Study Report (CSR), Integrated Summaries of Safety (ISS), and Integrated Summaries of Efficacy (ISE). The FDA requires that these datasets and their corresponding Define-XMLs are submitted with reviewer’s guides that summarize the study protocol, statistical analysis plan, and metadata captured in the Define-XMLs. Ultimately, the objective of this data mapping process is to provide transparency and traceability of the analysis that was performed in a standard format.
Sponsors commonly wonder whether CDISC standards should be implemented from the beginning of clinical development, or whether it is more practical to hold off on conversion until it is known that the drug will be submitted for approval. Adoption of CDISC standards in early phase studies requires additional planning but leads to numerous downstream benefits.
Potential advantages of being CDISC compliant early in clinical development include:
When weighing whether to use CDISC standards, sponsors should consider what their clinical trial objectives are, how study data will be used, and which resources are available to support implementation. CDISC standards are complex, and implementation may require training or external support. In certain circumstances, it may make sense not to adopt CDISC standards, for instance:
If a sponsor opts to forego CDISC in early phase trials but needs those data for submission to the FDA, the data will require conversion to CDISC format. The cost of conversion at a later stage of clinical development is often higher than implementing CDISC in early phase studies due to:
Adoption of data standards supports the collection of high-quality evidence during clinical development. While the use of CDISC standards is associated with a variety of benefits, implementation presents both a technical challenge and a cost. Thus, determining when and how to implement CDISC standards in a clinical development program can be challenging. At Precision for Medicine, we have extensive experience helping sponsors identify the optimal time and approach for adopting CDISC standards.
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Ryan Kurz is a Director of Statistical Programming with more than 20 years of experience supporting clinical trials.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
