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Quantifying Site Burden to Optimize Protocol Performance.

Maria Florez1, Zachary Smith2, Zachary Olah3

  • 1Tufts Center for the Study of Drug Development, Tufts School of Medicine, Boston, USA. maria.florez@tufts.edu.

Therapeutic Innovation & Regulatory Science
|January 9, 2024
PubMed
Summary
This summary is machine-generated.

Decentralized Clinical Trials (DCTs) may increase site burden, with half of surveyed sites finding them more burdensome than traditional trials. Remote operational tasks are less burdensome, but patient-facing clinical procedures are more burdensome in DCTs.

Keywords:
Clinical research protocolsClinical study designClinical trial costClinical trial cycle timeClinical trial designDecentralized clinical trials (DCTs)Protocol complexityProtocol designSite burden

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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.