Human Interaction: Risk-Mitigation Recommendations When Using Technology In Clinical Trials

By Bill Barrasso, Clinical Ink

Recent advancements in technology have significantly expanded the reach of clinical studies, making them accessible to larger and more diverse populations. However, it's important to emphasize that technology alone cannot guarantee the successful completion of research studies. The human element, encompassing how sites, sponsors, and patients utilize technology while adhering to regulatory guidelines, remains paramount in upholding compliance, mitigating risks, and safeguarding patient well-being.

This article makes reference to the latest guidance documents issued by the FDA ("Decentralized Clinical Trials for Drugs, Biological Products, and Devices, Guidance for Industry, Investigators, and Other Stakeholders," May 2023) and the EMA ("Guideline on computerized systems and electronic data in clinical trials," March 2023). These publications underscore the critical role of human engagement when incorporating technology into clinical trials.

The FDA's draft guidance document offers a valuable compendium of evolving best practices for Decentralized Clinical Trials (DCT). Those new to this field will find it advantageous to delve into the specifics contained within this resource. Additionally, it includes crucial sections that delineate the responsibilities of both trial sites and sponsors, which are pivotal in ensuring the compliant execution of clinical trials.