Exploring the wider effects of participating in a clinical trial on clinical and research staff: a protocol for a qualitative study

Background

Participating in research is widely accepted to have benefits for participants, but there is less evidence about the impact on researchers, clinical staff and organisations involved in the research delivery.

Aim

To explore how participation in a randomised controlled clinical trial impacts on researcher development, professional development of clinical staff, organisational capacity and delivery of clinical services.

Design

Longitudinal qualitative study using interviews undertaken at three timepoints across the period of a clinical trial.

Participants and Setting

Three groups of participants involved in a clinical trial being undertaken at nine centres across India will be invited to participate. This includes: 1) Research staff involved in the design and delivery of the clinical trial; 2) Clinical staff involved in delivering the clinical aspects of the trial; 3) Organisational representatives from the hospital senior management teams at each site.

Materials and Methods

Ethical approval has been granted by University of Leeds Dental Research Ethics Committee and Bharath Institute of Higher Education and Research. Interviews will be undertaken virtually using communication platforms that are commonly used across India (Microsoft Teams and Zoom). Training and technical support will be offered to anyone who is not familiar with the platforms. Participants will be asked for consent for the interviews to be audio-recorded and auto-transcribed. Experienced qualitative researchers will facilitate interviews using a topic guide. Data will be collected at three time points: at the start of the clinical trial, 18 months and 3 years after recruitment commences. Analysis will follow an inductive reflexive thematic approach.