In an article published online ahead of print, leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the importance of independent oversight by a safety office or data and safety monitoring board in pragmatic clinical trials, even for trials deemed to have minimal risk.

Challenges specific to pragmatic trials include:

• complexity, quality, and timing of a real-world data pipeline, especially in trials with many heterogeneous sites
• embedding of interventions in clinical workflows, so investigators have less control over treatments or interventions
• potential for incidental and collateral findings

“We recommend regular, rigorous data quality checks, ongoing monitoring of adherence to interventions, and including someone who is knowledgeable about pragmatic clinical trials and novel research designs in the development of Data and Safety Monitoring Plans and Data and Safety Monitoring Boards,” the authors wrote.

By attempting to reflect real-world conditions, pragmatic trials are conducted in settings that cannot be closely controlled. Therefore, close monitoring is critical for a successful study that produces meaningful results, whether it be by independent monitors or data and safety monitoring boards.

The authors drew on experiences from 7 of the NIH Collaboratory Trials and the expertise of the Coordinating Center, the Ethics and Regulatory Core, the Biostatistics and Study Design Core, and the Health Care Systems Interactions Core.

The article was published in Contemporary Clinical Trials.