We all know that COVID-19 has had a significant effect on Australia’s healthcare system, however, how does COVID-19 impact clinical trials in Australia?
Medical research institutes are carrying out various research initiatives to find solutions that will protect the health and safety of the public and fight the spread of COVID-19. The Association of Australian Medical Research Institutes (AAMRI) has recorded over 100 research projects relating to COVID-19, where medical research institutes are taking steps to develop treatments, vaccines, drug screening, testing and diagnostic tools, data modelling, resources for the management of mental health, indigenous health and other areas of key concern.
Despite the high demand and influx of additional research projects relating to COVID-19, it is important for the existing research projects and clinical trials to progress.
The National Health and Medical Research Council (NHMRC) is a national body whose objects are to, inter alia, support activities created for the purposes of promoting both medical and public health research and training in Australia. During these unprecedented times, the NHMRC considers that the health and safety of communities, health consumers, researchers and support staff are paramount. The NHMRC has expressed that flexibility will need to be exercised, especially in circumstances where COVID-19 has delayed a research activity, and that grants may need to be varied as a result.
The NHMRC, together with the state and territory Departments of Health, the Therapeutic Goods Administration (TGA) and the Clinical Trials Project Reference Group (CTPRG) published a joint statement to provide guidance to institutions, Human Research Ethics Committees (HRECs), researchers and sponsors with respect to the conduct of clinical trial research during these challenging times (the Guidance).
The Guidance aims to “assist those overseeing, conducting and reviewing clinical trial research to maximise the safety of research participants and to minimise risks to participants and the community, to researchers and other institutional staff and to trial integrity, and to address prioritisation of clinical trial research.”
The Guidance recognises the importance of conducting COVID-19 related research, however, stresses the need to continue conducting other proposed and ongoing clinical trials.
The Guidance makes recommendations with respect to aspects of current clinical trials that may be impacted by COVID-19 and proposes the following steps should be taken by researchers, sponsors and other relevant stakeholders:
- Address the possible impact of and responses to COVID-19 by undertaking contingency planning.
- Ensure participants’, researchers’ and other stakeholders’ safety and well-being are paramount – should a clinical trial proceed in either its original or modified form, the participants should be asked whether they would like to continue, suspend and/or withdraw from participating in the clinical trial.
- If participants have COVID-19 symptoms, prior to attending any trial visits, they should notify the research team of their symptoms and the principal investigators of the clinical trial will need to arrange appropriate follow-up by assessing and testing such participants at an alternate site.
- Consider alternative models for conducting clinical trials, such as tele-trials.
- Ensure ongoing compliance with any guidelines, policies and procedures published by the NHMRC and the TGA with respect to safety monitoring and reporting – if a participant with COVID-19 symptoms attends a site, then this should be reported as an adverse event or safety issue.
- Particular variations to clinical trials will need to be notified to the TGA, such as changes to therapeutic goods and sites.
- Arrangements are made to ensure participants in self-isolation and/or quarantine as a result of COVID-19 continue to receive trial medication.
- Carry out remote monitoring visits where possible.
- Meetings with respect to the management of clinical trials should take place via video/teleconference.
- Consider suspending or ceasing clinical trial research, noting some studies may need to be reviewed by the HREC prior to cessation.
With respect to the management of new clinical trials, we understand that an expedited review process is available for research projects relating to COVID-19 and the researchers should liaise with their institutions and relevant Departments of Health in this regard. This may result in delays to new clinical trials proceeding that are un-related to COVID-19 issues.
It is clear that COVID-19 has impacted Australia’s health system as well as the management of current clinical trials in Australia. It is important that everyone involved in clinical trials take steps to comply with any advice, guidance, policies and/or legislation from the Australian Government or bodies such as the NHMRC to maintain the health and safety of all stakeholders involved in the clinical trial research as well as the public generally.