If you follow Siron Clinical on social media, you may have noticed that we have been sharing news, opinions and information about the Coronavirus pandemic in relation to clinical research, particularly in terms of how it’s affecting trials.
The pandemic was unexpected, but now we have an idea of its trajectory and the impact it might have in the long term. As a CRO, it’s important that we not only stay abreast of developments, but also think about the future.
Here we look at what has happened, the situation now, and where we’re likely to be headed.
COVID-19: the pandemic that changed clinical research
When the WHO declared COVID-19 a pandemic, various mitigation measures spread globally with the virus: physical distancing, closure of non-essential establishments, shutdown of hospitality premises, cancelation of non-emergent medical procedures, closure of schools, self-isolation for those who are vulnerable or showing symptoms. Many countries locked down completely.
These measures have taken their toll on the clinical trials industry. ClinicalTrials.gov listed 262,366 ongoing randomized clinical trials early on in the pandemic, and there has been widespread concern for their integrity. The impact on clinical trials has come mainly from two directions: the mitigation efforts and the ramp-up of the development of treatments and vaccines for COVID-19.
Social distancing has made many aspects of clinical trial management challenging. For some patients, home healthcare is the new reality. In the main, patient recruitment, monitoring, data collection, appointments and focus groups – all things that happened in person – have shifted online, wherever possible.
While digital approaches potentially has implications for relationship management and patient engagement, the move to online trial management has revealed a potential for technology that had not been recognized.
Then there is the very real threat to clinical trials that were already in progress or at the early stages of funding and approval. The demand for treatments for COVID-19 and an effective Coronavirus vaccine are dwarfing efforts toward other health challenges: at the time of writing, the Global Coronavirus COVID-19 Clinical Trial Tracker lists 1,570 clinical trials for COVID-19.
Resources are being redirected to manage the immediate threat, but that is putting pressure on trials for other pressing medical conditions.
The post-pandemic future of clinical trials
Countries are beginning to reopen, and an end is in sight. But we may not see life as we knew it for a while, if modeling predictions are correct that we should expect another wave of infections later in the year. Things have changed, including our approaches to clinical trials.
This isn’t all bad news. In fact, it has provided the industry with an opportunity to rethink approaches, improve efficiency and look at processes from a new perspective. There are a few things we predict we will be doing in 2021 and beyond, which add up to a transformation of clinical trials.
Embrace new technology
For millions of people, the workplace has become a Zoom window over the last few months. It might be getting frustrating, but technologies like Zoom have proven that business continuity is possible in many cases without human contact.
In the clinical trials business, the pressure has been on to find digital solutions to the road blocks that have halted many trials. As Donald Deieso, Ph.D., chairman and CEO of WCG, was quoted in Clinical Leader, “in this emergency situation there is not enough time for them to explore implementing remote enterprise solutions. That would take too long to install, integrate, and implement. This is a moment in which doing what works must become the priority.”
This has highlighted a surprising resistance to technology that was prevalent in the pharma industry. “Historically, I’ve always seen that our industry tends to be a more conservative industry,” said Baljit Samra, Castor Advisory Board member and former COO of the Duke Clinical Research Institute, in an article by Castor founder Derk Arts, MD, PhD.
“As long as we are conscious of the regulatory requirement around privacy and security, at this point in time, it’s going to be a blank sheet of paper as far as how we address research needs in both a technological and virtual manner.”
We may have passed the point of no return here – and with many technologies in development and already available to offer alternative approaches to different aspects of clinical trial management, we’re likely to see big changes here.
“The good news is the industry will not be able to put this genie back in the bottle,” Deieso said.
Follow new regulations and protocols
The very fabric of the clinical trials process has already shifted, with emergency measures put in place by the FDA, EMA and MHRA to accelerate development for COVID-19 treatments and vaccines.
“The regulatory guidance, from my perspective, offers a lot more flexibility than we’ve seen before,” Samra said.
This flexibility in regulation exists to speed up the mitigation efforts for COVID-19, but their success could mean some of the changes stick across the board in the future. That will be up to the individual agencies, of course, but it’s something to monitor.
Trial protocols have already changed, and some of the new approaches will stay the course. During the pandemic, attention has been paid to protecting employees as well as patients, limiting personal contact to only what is necessary and providing personal protective equipment.
With new technologies in place, it is easier to maintain this to some extent; patient monitoring and site visits could continue to occur online in the future. Fewer in-person meetings save time and resources, making the whole process run more efficiently. Why invite patients to the office for simple tests they could do at home and return in the mail?
Engage with patients in new ways
As noted earlier, this does have implications for patient engagement, and communication efforts will become even more essential in the future. Two-way communication channels, frequent opportunities for feedback and engagement and, where necessary, physical visits at home or in a healthcare setting will need to be balanced carefully in future trials.
During the pandemic, we have adjusted to new methods of communication, and our expectations have grown along with that. Patients may expect (near) real-time interaction online as well as different formats of information, such as videos and audio.
We are still working through the challenge of the pandemic itself now, but thinking about what is on the horizon for clinical trials – the things that are likely to take up permanent residence in our work – will help us prepare for what comes next.
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