A protocol on ‘clinicians’ perspectives on the barriers and enablers to activity in clinical trials.

Abstract

Background/aim: Based on the recent Clinical Trials Sector Report (2021), clinical trials contributed $1.4 billion to the Australian economy in 2019, facilitating job creation and sector skills development, and had a positive impact on both direct and indirect health outcomes. Capacity and capability of clinicians to take on the role of Principal Investigator (PI) and Sub-Investigator (Sub-I) in clinical trials is a limiting factor in clinical trials activity. This project aims to identify clinicians' perspectives on the barriers and enablers for clinicians’ activity in clinical trials within the role of PI/Sub-I. Population/setting: Grampians Health clinicians currently holding patient-facing roles, taking lead in medical care decisions or treatment plans for patients, including medical doctors, nurse practitioners, and allied health staff. Methods: This mixed-methods project is comprised of two parts: Part 1 adopts a qualitative approach via a focus group discussion exploring the barriers and enablers to clinical trial participation as PI/Sub-I. This will include a sample of clinicians who are currently active members of the Clinical Trials Initiative (CTI) at Grampians Health. Thematic analysis will be undertaken using the framework proposed by Braun and Clarke (2018). Themes identified from the focus-group will be utilised to inform survey development for Part 2. Part 2 entails collection of quantitative survey data consisting of questions around barriers and enablers to clinical trials activity. This survey will be extended to all Grampians Health clinicians, to help ensure collection of a broad perspective and accurate representation of clinicians’ experiences hospital wide. Descriptive statistics will be utilized to provide an overall reflection on the perceived barriers and enablers to engaging in clinical trials activity. Results: Not completed. Conclusion: Not completed. Translational impact/implications for future practice: The findings from this research will inform strategies aimed to enhance clinician capability and capacity in clinical trials in PI/Sub-I roles. Supporting clinicians to be more active in clinical trials will facilitate increased clinical trial opportunities for regional health service patients.