Home nursing in clinical trials: Result from semi-structured qualitative interviews

Area of Science:

• Clinical Research
• Healthcare Innovation
• Patient-Centric Care

Background:

• Conventional clinical trials (CTs) face challenges in patient recruitment, retention, and adherence.
• Decentralized CTs (decentralized CTs) offer a patient-centric approach, utilizing remote monitoring and telemedicine.
• Home nursing in CTs (HNCTs) is a key component for advancing decentralized trial models.

Purpose of the Study:

• To explore the understanding, perspectives, and ground realities of implementing HNCTs in India.
• To identify key areas and recommendations for facilitating the establishment of HNCTs in the Indian context.
• To address potential limitations and challenges associated with HNCT implementation.

Main Methods:

• Semi-structured qualitative interviews were conducted with diverse experts involved in CT conduct.
• Participants included researchers, clinicians, nursing staff, patient advocates, ethics committee members, legal experts, and trial participants.
• Qualitative data was collected to understand the practical aspects and expert opinions on HNCTs.

Main Results:

• Expert insights highlight the potential benefits of HNCTs for improving trial efficiency and patient experience.
• Key facilitators for HNCT implementation in India were identified, alongside potential barriers.
• Recommendations were formulated based on expert feedback to guide the establishment of HNCTs.

Conclusions:

• HNCTs represent a significant opportunity to enhance decentralized clinical trials in India.
• Addressing identified facilitators and implementing expert recommendations is crucial for successful HNCT adoption.
• This research provides a roadmap for integrating home nursing into clinical trial conduct in India.