The Value Of Data Standards In Clinical Trials: The Time Is Now

By Terek Peterson, Vice President, Clinical Analytics and Data Strategies

Adoption of data standards are necessary to underpin higher data quality, efficiencies and integrated applications across increasingly complex clinical research processes. Global regulatory agencies have clearly embraced data standards for the submission of data, laying the groundwork for expanded adoption, to data collection, tabulation and analysis.  Collecting data in a standardized way is the next step to reduce messy, time-wasting efforts that can negatively impact patient safety, development timelines and resource utilization.

On an organizational level, failure to establish standards upfront makes it difficult – and in some cases, impossible to connect data across disparate systems for efficient study execution.

Standards enable efficiency gains related to time-intensive processes involving acquisition, aggregation, analysis and report preparation through re-use of standard formats for protocols, case report forms (CRFs) and other data-related formats. Standards eliminate the expense and time of reformatting data for transfer to or from third party vendors, and converting proprietary data into standard formats.

Effective standards also drive access to data across trials, providing insight into trial design and operations based on past research experience.  With appropriate standards in place, data can be linked moving backward in time, much the way a genealogy traces ancestor lives. Standards make it possible to connect and trace previous research intelligence to mine historic trial data from the “genealogy” of a drug development program or therapeutic indication.