The clinical research sector is moving from the traditional site-based model of research delivery to a more participant centered approach. This project looks at how we can promote flexibility in clinical research, including trial activities in the home, at local clinics, on the cloud, and through wearables. Through a suite of practical tools, the project promotes flexible trial delivery methods without sacrificing the collection of high-quality evidence or participant safety.
Introduction to Flexible Trial Delivery: Increasing access to clinical research by offering flexibility
This short document introduces strategies for making clinical research more flexible for participants. It outlines why flexibility is important for participants, and how this can be designed into trial protocols and delivery plans. It also gives examples of what flexibility might look like in different situations.
This document has been developed by the project team and reviewed by our participant subcommittee. It is designed for people who may be new to flexible trial delivery methods – including research staff, local healthcare providers, and consumer representatives.
Design Checklist: How clinical trials can be designed to be more flexible in Australia
This checklist is for clinical trial sponsors, researchers, decision-makers and reviewers. It details high-level considerations for ensuring that flexible options in clinical trials comply with Australian and international regulations and standards. It focuses on areas where trial design and implementation are likely to differ when trials are delivered flexibly. Sponsors and researchers will need to discuss the details of their trial design with the relevant regulators and reviewers, following the usual processes.
The checklist was developed after extensive review of national and international guidance by the project team, which includes members who are experienced with adapting international protocols to Australian requirements.
Under development
This project is ongoing, with additional resources under development. We will add these resources to this page as they are completed. At this stage we anticipant this will include:
- A library of case studies
- A tool for conversations between site staff and participants
Contributions to the Toolkit
CT:IQ would like to thank everyone who shared their lived experiences of participating in clinical research with us. This includes consumers who were part of the project team, and those who took part in the participant subcommittee. We would also like to thank those who shared their professional experiences of designing and running clinical research projects as part of the project team, or in many other discussions of these topics.
Use of this material
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. © CT:IQ 2025
While CT:IQ endeavours to ensure the quality of this publication, it does not accept any responsibility for the accuracy, completeness or currency of the material included in this publication and will not be liable for any loss or damage arising out of any use of, or reliance on, this publication.