As the COVID-19 pandemic continues, day after day we are inundated with information. For the CRO industry, the message is that measures are in place and everything is under control; remote meeting and monitoring capabilities are keeping trials ticking over. This is true, but it’s only part of the story. In reality, remote monitoring is limited, as CRAs do not have access to source documents.
This will leave a backlog in monitoring that will have a significant impact when we reach the ‘new normal’. Everyone should be prepared, not just for this inevitable backlog, but also for the studies you have planned for the future.
The COVID-19 pandemic: impact on clinical trials
The coronavirus pandemic has put enormous pressure on hospitals and frontline healthcare workers around the world, and, of course, COVID-19 patients have priority now. This is already having significant consequences for hospitals and the industry – including financial impacts.
Clinical trial screening activities and enrollment have dropped significantly, and companies have decided to stop or put ongoing trials on hold. When the pressure on hospitals is released and trials begin to restart, there will be a significant delay affecting them. And the already increased pressure on regulatory bodies due to COVID-19 will be exacerbated with a wave of trials restarting after the pandemic.
All this will ultimately affect when treatments will become available to patients. But there are measures you can take to minimize the delay and keep your plans on track as much as possible.
Measures to keep trials running
During the pandemic, some trials have continued with remote monitoring, including safety monitoring, and risk-based monitoring. Safety information and study compliance can be monitored too, enabling safety reporting to regulatory authorities to continue as needed.
In an effort to ensure continuity in ongoing clinical trials, solutions have also been found to interact with study participants, including through remote visits and by shipping study medication directly to patients. This has so far been successful, especially for trials in rare disease indications.
However, remote monitoring and interaction solutions are not foolproof. One of the challenges remote monitoring brings is performing true source data verification. And not all study assessments can be completed with remote visits.
Preparing for post-pandemic plans
Regardless of the situation in the countries in which your trials are – or were – operating, you can make sure you’re ready for when things change. Whatever the impact of COVID-19 has been on your clinical trials so far, you will need to re-evaluate them in the post-pandemic light and make changes accordingly, on a site-by-site and country-by-country basis. Here are some questions to guide you.
Is your trial still feasible?
What worked before the pandemic may not work now. Look at your clinical trial with a fresh perspective and flag any areas that may need to be revisited, adjusted or cancelled.
Have you evaluated risks?
COVID-19 will have consequences for the design, testing and implementation of clinical research: disruption of clinical trials will be included as a standard when evaluating possible risks, especially in light of possible future waves of the pandemic. Ensure your risk assessment and risk mitigation plans are updated and reflect the current situation.
Are your contingency plans sufficient?
If the pandemic has taught us one thing it’s that we can’t always predict the impact the external world will have on our plans. Do you have solutions in place to ensure continuity in unforeseen situations? For example, look at possible solutions for speeding up patient recruitment.
Have you organized your trial administration?
You can get ready for your trial to (re)start by preparing the study documents, regulatory submission work and so on.
Is your team ready to roll post pandemic?
If your team has been in a holding pattern, or working on the front line in healthcare, they may need a refresher or some retraining.
Can you design your new normal?
One positive result we can take from the pandemic is the potential to choose new, optimal ways of running trials. To start the thinking process, you can ask questions such as ‘how will eTechnology be implemented in future clinical trials?’ and ‘do we always need patient on-site visits for study related assessments?’
As you get prepared for what’s next, Siron Clinical can help make sure you don’t face any more delays. We can support you with:
- Regulatory submission preparations
- Prepare study specific documents
- eCRF testing
- Vendor selection
- Consultancy services