Guidance and support for clinical trials


In support of the clinical trials sector and in recognition of the challenges the health system faces during the COVID-19 pandemic, a position statement has been developed by the Research and Development TaskForce (RDTF), sponsored by AusBiotech, Medicines Australia, and the Medical Technology Association of Australia, together with respective memberships.

This position statement details specific guidance on how and why clinical trial sites should remain open during the COVID-19 healthy emergency. As the COVID-19 pandemic unfolds in Australia, additional strategies will need to be implemented to ensure that the safety, well-being and ongoing conduct of clinical trials are maintained, with as little interruption and inconvenience to the participant as possible.

A flexible and supportive clinical trials environment should ensure that Australian patients are best placed to receive early access to experimental vaccines and treatments for COVID-19, and other innovative treatments, that they would otherwise not have access to.

The RDTF has formed a COVID-19 Working Group to support the clinical trials sector as the effects of the COVID -19 pandemic are felt around the nation. It is acknowledged that a strong collaborative sector-wide effort will be required, as there are many stakeholders involved in the delivery of clinical trials. The Working Group will look at all aspects of clinical trial delivery with the intent of ensuring that trial participants and trial sites are supported and where possible, that patients continue to receive treatment and all safety activities are completed.

Download the joint media release here, and the position statement here.

The NSW Office for Health and Medical Research (OHMR) has drafted guidance for NSW sponsors, researchers, HRECs and RGOs for conducting clinical trials affected by the COVID-19 situation. The guidance is designed to assist operational requirements and will be continually updated as the situation evolves. OHMR would like to continue to receive feedback on this guidance to ensure it covers appropriate areas of need. From this, a set of FAQs will be developed which will be added to progressively.

For more information, and to download the guidance, visit its website.

The Commonwealth Department of Health, with input from state and territory jurisdictions has produced a set of principles that are intended to have application nationally.

This guidance provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic. It is directed towards those involved in clinical trial research and other relevant clinical research, but also may be of use to institutions, HRECs and researchers in other fields. Read the guidance here.