7 July 2020
This article is the second in a series of articles that look at how COVID-19 is affecting the healthcare and life sciences sectors in Australia.
To read our earlier article on how COVID-19 is affecting the aged care sector, please click here.
The Australian Government has recently committed an additional AUD66 million towards clinical research and investment for development of a vaccine, treatments and responses to future pandemics in response to COVID-19. The funding is available through the Australian Government’s Medical Research Future Fund (MRFF), extending the AUD30 million already allocated to the Coronavirus Research Response.
There are four main areas the research aims to target: developing a vaccine for COVID-19; investment in antiviral therapies for COVID-19; clinical trials of potential treatments for COVID-19; and improving the health system’s response to COVID-19 and future pandemics.
While there has been an uptake of the additional funding by many Australian research facilities, including universities, existing clinical trials both locally and globally are being adversely affected by the COVID-19 pandemic.
With medical research ethics committees for clinical trials focused on the safety of their medical staff, deviations from existing protocols and administration of investigational drugs are impacting on the ability for existing clinical trials to continue. The delay has also been associated with site activation, enrolment, patient visits and/or data collection and cleaning. In addition to the ability for patients to mobilise to research treatment, COVID-19 lock downs have also impacted on the ability to transport medical and related diagnostic equipment for use in clinical trials.
Clinical research platform Medidata has been monitoring the enrolment data from nearly 4,600 current clinical trials and more than 182,000 study sites worldwide. The recent reports for this data show significant decreases in the number of new patients entering clinical trials for actively recruiting studies. The impact of COVID-19, however, varies across therapeutic areas. For example, enrolment in studies for respiratory diseases has decreased by 34%, while there has been an 80% decline for studies of endocrine diseases, 47% in infectious disease studies, and 70% for cardiovascular diseases. Data from ClinicalTrials.gov also indicates that over 200 interventional oncology studies were suspended in March and April 2020 owing to COVID-19.
Locally, the Australian Government has recognised that COVID-19 may also be affecting research involving animals, including delays to existing research projects, or new research relating to the pandemic that proposes to use animals.
From a claims perspective, management of staff, patient and volunteer safety is paramount for those persons involved in both COVID-19 clinical trials, as well as other research programs. Infection control measures require strict enforcement in order to ensure the management of disease and health of both patients and staff. This is particularly relevant to the categories of persons most at risk of health impacts from SARS-CoV-2 exposure, including the immunocompromised and those with various co-morbidities.
In addition to managing the exposure to SARS-CoV-2 in persons participating in clinical trials from a medical malpractice and personal injury claim perspective, insurers should also be cognisant of the potential impact of delays in existing clinical trials. For example, while the commercial impact of delays in clinical research and drug development is not yet known, the subsequent impact on contractual obligations and supply chains is likely to have a bearing on business interruption policies and overall industry profit margins.
For further information, please contact:
Lucinda Lyons, Partner, Clyde & Co
Lucinda.Lyons@clydeco.com
