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.
To find out more about the development of these tools visit About the FTD project.
1. 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. It is designed for people who may be new to flexible trial delivery methods – including research staff, local healthcare providers, and consumer representatives.
Recommended for: those who are new to these ways of working.
2. 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.
Recommended for: those who are developing or adapting trial protocols.
3. A Site Guide to Participant Flexibility
This guide is aimed to help site staff respond to participants needs for flexibility. It guides sites through the process of deciding which types of flexibility they can support at their site, and how to prepare for conversations with participants to choose the right
Recommended for: sites and those conducting consent discussions.
4. Flexible Trial Delivery Case Studies
The FTD project team have developed a suite of case studies that illustrate some of the diversity in how flexibility could be incorporated into a clinical trial. These provide examples for how Australian researchers have used a variety of tools to make an aspect of their trial more flexible.
Recommended for: those developing and delivering clinical trials.
Additional materials
Vision Accessible versions of the main FTD materials: