Clinical trials stall as COVID-19 deters clinician-patient contact


medical research labAs attention is focussed on urgent research to find a vaccine or treatments for SARS-CoV-2, other medical research is likely to suffer due to the general disruption caused by the COVID-19 pandemic.

Institutions, researchers, ethics committees and sponsors are receiving guidance on contingency planning and how they might manage the potential impacts of COVID-19 on research, particularly clinical trials.

A joint statement from state and territory Departments of Health, the TGA, NHMRC and the Clinical Trials Project Reference Group (CTPRG) emphasises that “the safety and well-being of trial participants, other patients, family members, researchers and other clinical and support staff is paramount.”

Importantly, any new recruitment to ongoing trials should reflect the most current public health advice on social distancing and consider the likely burden on the health system.

“In a situation where a trial participant is unable to attend a visit or otherwise fulfil a condition of participation due to public health directives or government policy (such as restricted travel between states and territories), sponsors and researchers are encouraged to facilitate the participant being able to continue to participate in the trial at a site that is within the limits of any such restrictions.”

Use of telehealth for visits and electronic consenting, and extended protocol timeframes were some of the suggested modifications to trials.

In trials that proceed, with or without modification, patients should always be given the options to continue, suspend or withdraw their participation.

The statement also said that researchers and sponsors should educate themselves about novel approaches such as decentralised trials (i.e. teletrials) and hybrid models in which participants can be recruited and participate remotely and data can be captured remotely via available technology.

And, “PIs, pharmacies and sponsors, where relevant, should develop plans to manage the continuation of clinically essential trial medication delivery to participants affected by self-isolation quarantine periods or as a result of testing positive for COVID-19.”

The FDA has offered similar guidance to US researchers.

New focus on COVID-19 research

Meanwhile there is a pivot to fast track and coordinate COVID-19 research.

Locally, the NHMRC has advised that a number of grant schemes have been delayed, cancelled or had deadlines extended, due to uncertainty around staffing and resources and the need for “all hands on deck”.

On the other hand, a Respiratory Medicine Clinical Trials Research on COVID-19 program has opened through the Medical Research Future Fund. A streamlined application process closes 6 April 2020 and the NHMRC is actively recruiting experts to act as assessors.

Globally, Lilly has announced a pause on new studies and enrolment into ongoing studies unrelated to COVID-19. More drug companies may follow.

In the UK, the NIHR Clinical Research Network is “pausing the site set up of any new or ongoing studies at NHS and social care sites that are not nationally prioritised COVID-19 studies.”

“This will enable our research workforce to focus on delivering the nationally prioritised COVID-19 studies or enabling redeployment to frontline care where necessary.”

Protect research assets

Professor David Whiteman

Professor David Whiteman

Professor David Whiteman, acting director of QIMR Berghofer, told the limbic that all their research had been affected to some degree.

“A lot of clinical trials have really slowed down recruitment or pretty much stopped because it is not deemed essential and puts staff and potentially patients who may be vulnerable at risk.”

“Medical research has lots of critical assets and trained staff looking after them that you can’t abandon. All of those assets need to be protected for their own sake and for the future. We plan to bounce back.”

He said the Institute was ahead of the federal government in cancelling overseas and domestic travel, conferences, seminars and learning programs in order to protect its staff and assets.

“We will be resurrecting those through Zoom but we just have to get a bit more bandwidth and capacity, but that is the plan.”

People who can work from home were doing so – temporarily kept busy analysing data, preparing grant applications, reading the literature or writing manuscripts and PhD theses.

“There is work you can do but the bench based work is also getting harder.”

“If we lose a member of a team because they have got COVID, then the whole team goes into quarantine and you’ve got a massive problem because you can’t staff this facility.”

He said other strategies were also in place to reduce interactions such separating research teams into smaller teams and using different shifts and rosters.

“There is a capacity constraint on what they can do in any day so a lot of the work has to scale back … we can’t keep going at full capacity …”

“We’ve got other things like PC3 laboratories that are special, highly contained virus laboratories, where we’re actually doing COVID research as it turns out.”

“We have to keep that completely locked down so that means you have to have engineers there, certified staff there, you have to ensure the power supply continues for freezers stocked full of viruses.”

He said that adding to the crisis was the fact that supply chains for reagents and basics like ethanol were not secure.

“We have pretty good procedures in place. They’re not always fit for purpose because a pandemic is something we haven’t seen since the Spanish flu but the thinking behind it is there, and the planning, and the roles & responsibilities are clearly argued.”

“We’ve also formed a cabinet to simplify and speed up our decision making processes. It’s much less about governance now and much more about scientific assets, safety and people.”

He added that the ethics committee was working over time now to fast-track COVID-19 applications without compromise on issues such as safety.

“While a lot of our research is scaling down, COVID-19 is scaling up and so we have to make sure we have got the scientific facilities that these guys need to do their work. This is one area where we are busier than ever and quickly working with our hospital partners so we can get blood samples and nasopharyngeal swabs etc. from hospital colleagues so we can do our viral work on those and give data back.”

He added the generosity of supporters during the crisis had been fantastic such as $1 million for COVID-19 research from the Institute’s major donor Clive Berghofer.

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