Since our last article about choosing partners for virtual clinical trials, the data has revealed a shift in interest. What I mean by that is while in March of this year ‘virtual clinical trials’ was the most popular keyword in Google, in recent weeks ‘decentralized clinical trials’ has gained more volume.
Now, I am not one to draw conclusions based on a single indicator. Yet, I can’t help but feel that this is reflective of a different kind of change I’ve been observing – the shift from contingency planning thinking to a proactive embrace of change.
Let me tell you what I mean by that.
“Virtual” clinical trials
Virtual clinical trials are trials that are fully virtualized, siteless and fully remote (otherwise they would be called ‘hybrid’) – from the patient recruitment and administering of the investigational drug to the process of monitoring and data collection. According to the FDA, a virtual clinical trial is one where technology facilitates all human interaction.
A lot of ink has been spilled online about virtual trials as a contingency strategy – the 2020 lockdowns made this a necessary conversation to have. After all, with no other option, patients had to be supported remotely in order for research to continue. And technology was fully prepared to help in that endeavour.
Still as Maya Zlatanova points out, we can be tempted to see virtualization of trial components as a one-off thing for the sake of trial continuity and lose sight of the long-term vision – making clinical trials accessible to a wider population of patients.
‘Virtual clinical trials’ has a very hip vibe to it. To this day, our Guide to Virtual Clinical Trial Vendors is our most downloaded resource. People want to join the trend because it holds the promise of more efficient trials and overcoming barriers to participation – especially of the ‘convenience’ kind.
However, we cannot afford to think of virtual clinical trials as a trend if we want to bring about a lasting change in the way trials are designed and conducted.
“Decentralized” clinical trials
‘Decentralized clinical trials’ probably best captures the spirit of patient-centricity underlying the need for change in the industry.
While fully virtual trials can also be called decentralized, not every decentralized trial is fully virtual, and sometimes hybrid clinical trials can fall under the definition of decentralized. A panel at the 2019 CNS Summit reached the consensus that they all prefer the term ‘decentralized clinical trials’. An FDA representative at the 2019 DIA expressed that the FDA supports the adoption of ‘decentralized’ trials and insists on the correct use of the term.
This is part of the reason why I generally feel that the term decentralized clinical trials does more to articulate the underlying intention behind the adoption of remote patient support technologies.
Adoption of virtual trial elements is not just a plan B in the face of obstacles and further, decentralization does not necessitate virtualization. The decentralized model is a more flexible one that can still preserve physician-to-patient connection while enabling remote support when needed.
Decentralization is also a ‘from-the-get-go’ strategy. It is more difficult to decentralize an ongoing study than to go DCT from the start. And if the main goal is relieving the burden on patients and reaching more diverse patient populations then planning a decentralized trial up front makes more sense.
I may have left the wrong impression – I don’t actually mind people jumping on the virtual components trend. Covid-19 made it necessary to include virtual elements and this is what brought life to the conversation about decentralizing clinical trials.
Sooner or later, however, professionals involved on all levels of the trial process realise that what might have begun as a mitigation strategy is much, much bigger, requires a more dramatic shift on industry level and also has the potential to change trials forever.
DCTs can make clinical research more efficient, help reach more patients, get richer data, and eventually put new, better treatments on the market sooner. And this is something we all ultimately benefit from.
So, in other words, what might have started as a trend is sure going to lead to a mindset shift within the industry that’s been a long time coming.
At TrialHub we are aware that there are some cultural specifics that need to be considered when planning DCTs. This is why our country advisors can contribute insights about the local patient landscape and patient attitudes towards remote support. Older patient populations, especially in certain regions, can be more skeptical of technology and prefer face-to-face contact. If the ultimate goal is patient-centricity, knowing these specifics up front is crucial. This is why I maintain that DCTs are about flexibility and centering patients’ needs, rather than a race to virtualize every possible trial component.