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Background <p>Decentralized clinical trials (DCTs) are increasingly being used to enable greater participation of patients in clinical research and improve the patient experience. In 2021, the Chiesi research and development team established the Digital innovAtion for patieNt Centric hEalth (DANCE) initiative with the aim to enhance the clinical trial journey for participants by merging patient perspectives with modern technology. As part of this project, the concept of DCTs was explored with patients affected by respiratory or rare diseases and with healthcare professionals (HCPs) treating these patients in the USA and Europe.</p> Methods <p>The concept of the clinical trial journey and DCTs were initially explored through semi-structured interviews with 37 patients and HCPs. A follow-on web survey of 390 patients and HCP participants was then performed to gather opinions on the different components of DCTs and to identify elements to be incorporated in future DCTs. A final web survey with 135 patients and caregivers expanded on the DCT concept focusing on direct-to-patient delivery of investigational medications.</p> Results <p>Overall, both patients and HCPs liked and were open to the concept of DCTs. They believed this approach in clinical trials would avoid patients having to travel long distances for screening or study visits, and increase participation of diverse populations in trials. The main concerns for both patients and HCP participants were the reduction of face-to-face interactions and whether the technology would be easy to use.</p> Conclusions <p>This work highlights the benefits of DCTs and identifies potential challenges to be addressed to make DCTs more appealing to all participants. Responses also demonstrate the significance of integrating face-to-face contact with remote contact through user-friendly tools.</p>

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Opportunities in Development of Patient-Centric and Decentralized Clinical Trials: Insights from Patients and Healthcare Professionals in Respiratory and Rare Diseases

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月20日

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  • Marisa Minetti,
  • Eva Topole,
  • Ilaria Rondinone,
  • Marta Lombardini,
  • Paola Kruger,
  • Mario Picozza,
  • Simona Barbaglia,
  • Andrea Terenzi,
  • Ian Culverhouse,
  • Lisa Forde,
  • Isabella Montagna,
  • Ylenia Paleari

摘要

Background

Decentralized clinical trials (DCTs) are increasingly being used to enable greater participation of patients in clinical research and improve the patient experience. In 2021, the Chiesi research and development team established the Digital innovAtion for patieNt Centric hEalth (DANCE) initiative with the aim to enhance the clinical trial journey for participants by merging patient perspectives with modern technology. As part of this project, the concept of DCTs was explored with patients affected by respiratory or rare diseases and with healthcare professionals (HCPs) treating these patients in the USA and Europe.

Methods

The concept of the clinical trial journey and DCTs were initially explored through semi-structured interviews with 37 patients and HCPs. A follow-on web survey of 390 patients and HCP participants was then performed to gather opinions on the different components of DCTs and to identify elements to be incorporated in future DCTs. A final web survey with 135 patients and caregivers expanded on the DCT concept focusing on direct-to-patient delivery of investigational medications.

Results

Overall, both patients and HCPs liked and were open to the concept of DCTs. They believed this approach in clinical trials would avoid patients having to travel long distances for screening or study visits, and increase participation of diverse populations in trials. The main concerns for both patients and HCP participants were the reduction of face-to-face interactions and whether the technology would be easy to use.

Conclusions

This work highlights the benefits of DCTs and identifies potential challenges to be addressed to make DCTs more appealing to all participants. Responses also demonstrate the significance of integrating face-to-face contact with remote contact through user-friendly tools.