Of course, the big clinical trial news topic of the year is COVID-19 – particularly trials to test vaccines and treatments. But there has also been a lot of news on the impact of the pandemic on trials related to other diseases and conditions, and how to mitigate that impact. While the industry has slowed down, trials are still running, and changes in technology are bringing new opportunities
The Big Headline: Covid-19 Trials
Much of the world’s research and development resources have been directed to solving our most immediate problem: the Coronavirus pandemic. In August, the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health announced the Coronavirus Prevention Network, “to conduct Phase 3 vaccine and monoclonal antibody efficacy studies for the prevention of COVID-19.”
This is just one of many initiatives to prevent and treat COVID-19, including hundreds of clinical trials. To help people keep up with what’s happening, Impaq created a dashboard that displays all ongoing trials. It’s publicly available and lets you filter by intervention type, drug category and location.
One of the issues of COVID-19 drug development is the time it usually takes; we need vaccines and treatments as soon as possible. Computational approaches can help here, and a team at the University of Chicago has used them to identify an existing drug that might be effective against SARS-Coronavirus-2. Ebselen is a drug that has been investigated as a treatment for stroke, bipolar disorder and Clostridium difficile infection.
This time crunch also means it’s best to work within existing infrastructure, as much as possible. For example, by repurposing infrastructure, Nicole Mather and her colleagues made changes that “allowed the NHS to run the biggest randomized COVID-19 clinical trial in the world.”
While the focus of most trials is on looking for effective treatments for COVID-19, there are mental health effects we shouldn’t forget. In a revised version of the ENHANCE well-being program, a new study involving more than 2,000 participants is designed to address the challenges of COVID-19.
The Impact Of The Pandemic On Other Trials
This focus on COVID-19, coupled with mitigation efforts to prevent its spread, has had a significant impact on the thousands of clinical trials that are active for other diseases and conditions. According to a recent study by researchers at the University of Southampton, “more than 1,500 clinical trials of new drugs and treatments had been permanently closed, while a further 9,000 had been suspended.”
GlobalData reported that there may be an end in sight to the disruption already. Since March, they have been tracking 1,000 organizations involved in clinical trials; they noted that in June, reports of disruption to trials – including delayed start and slow or suspended enrolment – started decreasing.
One of the impacts on clinical trials has been the increase in costs involved in running a trial: experts estimate that clinical trial sites have seen a 30% increase in costs, mostly due to the crucial switch to remote monitoring. Enrolment has suffered too, and while it seems to be rebounding in the US, it is still only at 38% of pre-pandemic levels.
An article in The Lancet reports that despite this gradual reduction in disruption, the pandemic may have changed the face of the clinical trials industry permanently. As Aaron van Dorn writes, with a shift in focus and changes in the way clinical trials are approved and run, “the effects of the COVID-19 pandemic will be felt in clinical trials research long after the initial effects have faded.”
Industry Insights: How To Manage Clinical Trials
The industry certainly isn’t going anywhere, and as we return to running trials, we should be focused on doing it well. There have been recent reports showing the disparities in the enrolment of different demographic groups in trials. For example, in one study, researchers found that while two-thirds of black participants had been identified through their electronic medical record, they did not have an active patient portal and instead found out about the trial by mail.
While we need to solve issues of access and usability, technology can be an important component of a clinical trial, and it can also be applied in the intervention itself. AI in particular has great potential for things like diagnosis, decision support and treatment recommendation. But it’s still relatively new, and guidance is needed to ensure its proper use in trials. The Lancet recently reported new guidelines for clinical trial protocols – the SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence).
There’s also room for creativity when it comes to the type of trial you run, especially if there are restrictions. A randomized controlled trial might be the gold standard, but if that’s not possible, either because of ethics or feasibility, historical data could be one option. A paper in Nature Reviews Drug Discovery explores the option of using historical clinical trial data and collecting new control data – and the challenges this approach brings.
Whatever trial you run, accurate reporting is critical – but it’s not always done well. According to a paper in Trials, in 74% of cases, there was a discrepancy between the results reported in ClinicalTrials.gov and the corresponding publication of the clinical trial. The researchers suggest that “a checklist may provide a systemized procedure for investigators and editors to monitor accurate reporting.”
And while accurate reporting is a challenge, the even bigger problem is those not reporting at all. There will now be sanctions for this, in the US at least: the FDA has warned that fines will be issued for trials that do not report data to ClinicalTrials.gov.