I am not an expert on the matter but ever since my sister could not take part in a clinical trial due to it being too far away, I’ve been closely observing the space.
I’m glad to see it accelerating steadily since the COVID-19 outreach. Yet, there is great disbelief that DCTs can happen in Europe. This is what one of the Top CROs told me a few weeks ago, and it was for a reason.
Traditionally, the USA has been a different market and system for clinical research. Europe is the second largest of course. Throughout the USA there has been a well-developed network of private sites completely dedicated to conducting clinical trials, the professional sites.
Where in Europe they heavily rely on the government-funded hospitals where the majority of patients go. My research, however, shows that no matter how funded, investigators are open to providing remote support to patients. So this is not the key thing preventing DCTs.
Let’s look from another perspective.
In the USA for a long time, there’s been talk about the Walgreen’s and CVS’s and the likes becoming mini health/lab centers for supporting patients as people usually live away from the big centers.
They naturally also become hubs for supporting patients that would visit the shopping centers anyway and find it more convenient than a site visit to the nearest big city. This is a great solution, especially in distanced and underserved communities.
I believe this is possible throughout Europe as well. Besides the hospitals, in almost every country there is a network of private labs much like the local shop, where at least part of the examinations can happen. These private labs are usually part of a big pan-European private organization so conducting clinical trials across multiple countries will be just a matter of negotiations.
So, where does the disbelief come from?
Regulations?
Regulations are another thing. The FDA is leading the way to new methodologies for conducting clinical trials and similar to what happened during the first months of COVID-19, EMA followed.
While EMA is THE European institution, different countries still have the freedom to translate regulations in their own country in another way, so regulatory freedom is still there. But isn’t it the same across states? Yes, it is.
My 50 cents here is that regulations are not much different between the USA and Europe (or soon won’t be), it’s a matter of fact for them to sync and find the best solution. Especially when we speak about DCTs, the main challenge is things like:
– e-Consent: is an e-signature accepted and what does e-signature in the country mean;
– let’s say my general authority approves my remote nursing solution (for example) but what about the ethics committee (NB! EC is an IRB in the USA. And this is what could be a difference as there is a good institutionalized IRB system in the USA, where in Europe this is fragmented and so you can hardly generalize what to expect in different countries and sometimes cities).
These are not closely related to standards like GCP or anything related to site organization, rather connected to other governmental laws and culture.
Since Europe has not just multiple states but whole countries with different languages and backgrounds, it’s harder to look at it like one big market where you can implement DCT across the board. This is similar to every other business, so maybe the answer is going country by country?
If you ask me the biggest challenge that comes with DCTs in Europe is the lack of vendors. It’s true that the USA is the land of entrepreneurs. The big private market has made people think of ways to support clinical research through technologies and services way before COVID-19. And as we saw in Europe, this was not the case.
Yet, this is again a matter of time as US companies providing remote nursing, platforms for DCTs and patient recruitment are steadily entering the market. On top of that, there are European players too you can rely on to help you navigate the local ecosystem. If you are interested in lists of vendors for DCT, ping me here and I will send a catalog with virtual trials providers, and here is also a brilliant article by Kunal Sampat that you can use to see alternatives and ways to reduce your cost.
In summary, DCTs in Europe is “Mission possible!” but it will take time and experiments which sponsors should be open to in order to improve the patient journey.
I believe here’s where CROs play a role, to be the experts and lead the way to new and more efficient clinical trials. Not only CROs but pan-European projects like Trials@Home also aim to make DCTs happen and create standards for conducting DCT trials in a more structured and predictable way.
We need to roll our sleeves, be patient and continue innovating so that Disbelief becomes Confidence.
P.S. About GDPR: Many companies are concerned about GDPR compliance. But GDPR is not much different than other regulations like the Californian Data Privacy Act. The real difficulty with GDPR is that it made a lot of noise and people are scared, where what they need to do is understand how GDPR works and ensure the user experience is compliant.
This usually comes down to: open Terms and Conditions and being able to manage people’s data (delete for example when being asked) which is something that most companies should be able to do or at least they can rely on software like Pryv to help them have the compliance level they need in every single country.
Are you planning to incorporate virtual modalities in your trial? Finding vendors can be a real challenge. Check out The Ultimate Guide to Virtual Trial Vendors to find the best partners for your virtual/hybrid clinical trial.