March 31, 2020
COVID-19 represents an unprecedented challenge to the health and research sectors.
ANZGOG has consulted widely with its Trial Investigators, hospital sites and operating centres to ensure it is taking the best possible approach to its care of patients participating in ANZGOG clinical trials. We are continuing to treat patients on ANZGOG clinical trials wherever this is feasible.
ANZGOG’s decision-making reflects the shared views of all state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC).
Our response to managing our clinical trials is in line with several key principles and considerations set out by the combined Clinical Trials Project Reference Group (CTRGP) statement. These are:
- The safety and well-being of patients, research participants and their families, and health care professionals, researchers and other staff involved in patient care and research are paramount.
- It is critical that public health systems remain able to respond to the needs of the community, both those impacted by COVID-19 and in terms of regular workloads.
- The conduct of research related to COVID-19 is a significant priority; however, the initiation and continuation of other ongoing and proposed research may also be critical for the well-being of patients, participants, communities and the research sector.
- Compliance with or adherence to regulations, guidelines, codes, policies and other standards remains necessary. However, interpretation of research responsibilities in the context of a crisis such as COVID-19 should be informed by flexibility, consultation and good sense so as to retain the focus on the safety and well-being of those most at risk in our institutions and communities.
With these principles informing ANZGOG’s actions, we are working closely with our sites to ensure the well-being of patients on our clinical trials. This includes encouraging sites to use tele-health as much as possible in managing patients on trials.
We understand that there will be anxiety and concerns amongst women who are participating in an ANZGOG clinical trial regarding the best approach to treatment. Patients are encouraged to speak with their oncologist regarding their concerns including the best ways for their continuance on a clinical trial.
ANZGOG will continue to provide updates as changes occur.
Release dated 31 March 2020.