Quantifying Site Burden to Optimize Protocol Performance.

ABSTRACT

BACKGROUND: The increase in protocol complexity and the resulting rise in the effort required by investigative sites to implement protocols have been well documented, but existing measures of site burden only offer an incomplete view of the burden experienced by site personnel. The introduction of Decentralized Clinical Trials-trials supported by remote and virtual technologies and services-is expected to impact the burden imposed on sites, but this impact has not yet been systematically measured. METHODS: The Tufts Center for the Study of Drug Development conducted an online survey among clinical research sites worldwide and gathered 355 responses assessing the burden associated with distinct activities and procedures related to the implementation of clinical trial protocols using traditional and decentralized approaches. RESULTS: A high percentage of investigative sites (50.5%) have had no experience with DCT solutions and only a small percentage (6.6%) have participated in fully decentralized clinical trials. Overall, half of respondents view DCT solutions as more burdensome than traditional clinical trials. In general, activities related to operational and managerial aspects of trial implementation were viewed as less burdensome when done remotely, while clinical procedures or elements that require study team-patient interactions were viewed as more burdensome when using DCT approaches versus in-person or traditional methods.