Two weeks ago I was invited to speak at the Festival of Biologics in Basel, Switzerland. As a part of their Clinical Trials Conference, I was speaking about the ways we can measure whether patients find your clinical trial attractive. I also hosted a round table about “Remote Clinical Trials”.
A lot of people joined me to discuss this topic- representatives of sponsors, regulators, sites, and CROs, and I was surprised that the first question that almost everyone asked was:
What are actually remote clinical trials?
And the second one:
What is the difference between virtual, decentralised and remote clinical trials?
I am following the remote clinical trial landscape in the last 3 years and decided it’s about time to start talking about it. Thanks to the round table two weeks ago I realised that one of the reason we are not moving that much in the direction of remote trials is because of the many uncertainties we are not discussing openly.
So today this article should reveal some of the mysteries around remote clinical trials and I am happy to learn if you have more questions or maybe information about the same topic:
1. What is a remote clinical trial?
The name speaks for itself. Remote comes from the fact patients are monitored remotely and not only at the site.
2. If patients are monitored remotely, how would you get the data and ensure safety?
Patients’ data and security are being monitored thanks to medical devices and smart algorithms that read the data and translate it into actionable information for the investigators.
3. Are there already medical devices approved to be used in such trials?
Many and not only medical devices but also mobile applications. Yet, the challenge is how do we unify the data we get from all these different devices and what do we do with all the data that we are getting now.
4. Is there a difference between remote vs decentralised vs virtual clinical trials?
Yes, and No 🙂 It depends whom you ask. In general, they should all mean that a patient is somewhere away from the site while being monitored or supported. Here are some differences to consider:
- Remote as mentioned above is any clinical trial that supports a remote type of patient monitoring.
- A virtual clinical trial might mean the same, however, in most cases, these trials just have a technology that allows virtual support and maybe even site visits.
- Decentralised is maybe the most used term by regulators. At the last DIA in San Diego an FDA representative was very passionate when explaining that they accept only decentralised and the rest are just variations. If we speak about details here: Again we have a patient that is monitored remotely. In this case, though we know that there is one central site that supports patients miles away and these patients have a local office/team to do the more routine check-up or in case of emergency (the so-called satellite site)
5. What about regulators?
Regulatory agencies like FDA and EMA went publicly by saying they are open to “experiment” with new types of clinical trials. The main issue is that the regulators do not guarantee that they will accept the data and results at the end of the day. This makes a lot of people and companies wonder if they should go ahead or just wait.
6. How can you experiment with remote trials and still be safe with regulators?
There are a few brave pharma companies (and I would say brave managers) who are experimenting in this field, trying to learn from their mistakes and progress. Merck, Novartis, Sanofi are just some of the pioneers.
What their teams have been doing to ensure alignment with regulators but also opportunities to experiment is to choose one or two clinical trials that are a good fit for the purpose and in a chosen location to get an approval for a sub-study whose goal is to get experimental data.
This means that they would get their data for drug approval in the traditional way but parallelly they will collect data the remote way and then will compare. In this case, though, the “remote” data will not be taken into consideration for the final drug approval.
7. Are remote clinical trials cheaper?
No, at least the moment. Because at the moment we have to do a lot of customisations on top of what we are already used to in order to be able to support remote trials. On top of that in most cases, we are doing hybrid clinical trials which means that some patients will choose the traditional trial and some the remote one.
8. What do we need remote clinical trials for then?
Patients! Patients! Patients! The traditional type of clinical trials have been extremely inefficient recruiting patients which causes a lot of delays and higher budgets. With the increasing competition of new companies coming and therapies discovered, the number of patients we need gets higher and higher.
One way is to increase the number of sites we open to support that, however, these sites also have limited capacity. So then the solution is connecting more patients to these sites and making it possible for them to participate.
With personalized medicine knocking on our door, I think there is no need to explain that we need remote/decentralised/virtual or whatever you call this new generation of clinical trials.
We don’t know many things yet but at least we are backed by the technological progress and the new generation of patients coming to expect from us to be flexible and innovative.
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. Find the best partners for your virtual/hybrid clinical trial.