A systematic review of methods used to conduct decentralised clinical trials

Aims To evaluate, using quantitative and qualitative approaches, published data on the design and conduct of decentralised clinical trials (DCTs). Methods We searched MEDLINE, EMBASE, CENTRAL, PsycINFO, ProQuest Dissertations and Theses, , OpenGrey and Google Scholar for publications reporting, discussing, or evaluating decentralised clinical research methods. Reports of randomised clinical trials using decentralised methods were included in a focused quantitative analysis with a primary outcome of number of randomised participants. All publications discussing or evaluating DCTs were included in a wider qualitative analysis to identify advantages, disadvantages, facilitators, barriers and stakeholder opinions of decentralised clinical trials. Quantitative data were summarised using descriptive statistics, and qualitative data analysed using a thematic approach. Results Initial searches identified 19 704 articles. After removal of duplicates, 18 553 were screened, resulting in 237 eligible for full-text assessment. Forty-five trials were included in the quantitative analysis; 117 documents were included in the qualitative analysis. Trials were widely heterogeneous in design and reporting, precluding meta-analysis of the effect of DCT methods on the primary recruitment outcome. Qualitative analysis formulated 4 broad themes: value, burden, safety and equity. Participant and stakeholder experiences of DCTs were incompletely represented. Conclusion DCTs are developing rapidly. However, there is insufficient evidence to confirm which methods are most effective in trial recruitment, retention, or overall cost. The identified advantages, disadvantages, facilitators and barriers should inform the development of DCT methods. We recommend further research on how DCTs are experienced and perceived by participants and stakeholders to maximise potential benefits.

Automated summary

This study aims to evaluate the design and conduct of decentralised clinical trials using quantitative and qualitative approaches. The quantitative analysis included 45 randomised clinical trials, with the primary outcome being the number of randomised participants. The qualitative analysis included 117 documents discussing or evaluating decentralised clinical trials. The results showed heterogeneity in the design and reporting of trials, and insufficient evidence to support the effectiveness of DCT methods in trial recruitment. The qualitative analysis identified four themes: value, burden, safety and equity. Further research on participant and stakeholder experiences of DCTs is recommended to maximize potential benefits.