Quantifying Site Burden to Optimize Protocol Performance.

Area of Science:

• Clinical Research
• Health Informatics
• Drug Development

Background:

• Protocol complexity increases investigative site workload.
• Current measures of site burden are incomplete.
• The impact of Decentralized Clinical Trials (DCTs) on site burden is not systematically measured.

Purpose of the Study:

• To assess the burden of Decentralized Clinical Trials (DCTs) compared to traditional clinical trials.
• To evaluate the impact of DCTs on clinical research site personnel.

Main Methods:

• An online survey was conducted among global clinical research sites.
• 355 responses were collected assessing site burden for distinct trial activities.
• Both traditional and decentralized approaches were evaluated.

Main Results:

• Over 50% of sites have no experience with DCT solutions; only 6.6% have conducted fully decentralized trials.
• Half of respondents perceive DCT solutions as more burdensome than traditional trials.
• Remote operational/managerial tasks are less burdensome, while patient-facing clinical procedures are more burdensome in DCTs.

Conclusions:

• DCTs present a mixed impact on site burden.
• Remote execution benefits operational aspects, but challenges arise in patient-interaction procedures.
• Further research is needed to optimize DCT implementation and mitigate site burden.