A few months ago, we launched the first global database of virtual trials as part of our platform TrialHub. We work with feasibility, startup, patient recruitment, and clinical operations experts to support them in clinical trial planning.
The COVID-19 pandemic made it clear that the clinical research industry needs to be able to provide remote support to patients and to learn how to become excellent with virtual/decentralized clinical trials.
Excellent, though, means going through a lot of similar trials and collecting lessons learned which later become the Standards for how to conduct such a trial.
Most of you are new to virtual/ decentralized clinical trials, but they are definitely not new. In 2011 Pfizer started with the first “experiment” to run a virtual clinical trial and since then there have been more and more studies.
It’s important to mention that the name virtual can be understood in many different ways: fully virtual, mix between virtual elements, face-to-face activities, remote support, visits at home etc. But for the sake of simplicity, let’s call all variations virtual.
As mentioned, what we need in order to know how, when and whom is most of all experience and lessons learned. Our team wanted to see if there were any lessons learned in the past clinical trials which we can apply today.
First, we needed to identify which are the components that make a clinical trial virtual. Thanks to in-depth research done by institutions like Tufts Clinical and Translational Science Institute we’ve been able to identify the main components differentiating virtual trials from traditional ones:
- Mobile Applications
- eConsent (here is a list of providers)
- ePros (here is a list of providers)
This really helped us to build our database of virtual clinical trials and start learning from them. What did we learn:
There are a lot of things we’ve learned. Yet, I will focus in this article on the 5 main things a company should consider when planning a virtual trial’s success. There are all a part of the preparation that can determine if you will be successful or not. Here is a list:
Clinical trial endpoints and the virtual trial components used to gather the endpoint data:
This is a huge topic and we will discuss it in more detail in a separate article. The good news is there are plenty of technology and wearable providers for FDA-approved ways to ensure you can collect data on your endpoints in a remote setup.
A benefit of collecting data this way is that usually, these technologies allow 24-hour monitoring. Of course, there is a negative side to that. 24-hour data collection requires a different way of analyzing data. Hopefully, this will also lead to a lot more advanced and personalized approach towards treatments and patients.
The question here is:
Which are the wearables and technologies already used in a given indication?
There are great services like Elektra Labs that match wearables to endpoints for remote monitoring. But if you are asking about if there were already trials using them and what happened, then TrialHub can help too.
It’s interesting to see that some endpoints have been used for a given indication, but not necessary across Therapeutic Area. This has to do also with the next thing to consider:
FDA, EMA, and all local regulatory bodies have never been against virtual clinical trials, there were pro safety and quality data. If you follow general requirements, they won’t really care if you are conducting virtual, hybrid, decentralized, or whatever you want to call it study.
At the same time, we know a trial is not just a trial in a given indication. It is a trial with a protocol, requiring a specific patient population in a specific setup. This means that sometimes country regulatory bodies and ethic committees might approve your virtual trial or they might not.
How can you find out if a country institution is likely to approve your virtual clinical trial?
Since the beginning of the year, there have been multiple private and institutional efforts to bring together more information about the country’s approvals. As there are so many different components making a trial virtual or not, it’s hard to have it all in one (yet), but there are some which are pretty good for the main components. For example, TransCelerate has put together a comprehensive list of countries where eConsent is accepted.
As part of TrialHub, we also match the virtual components with the countries where they have been approved. This is very much indication-specific but the more virtual trials out there, the more know-how we will all have.
Let us know if you have a specific indication at firstname.lastname@example.org and we can check if there are any components used and in which countries.
Standard of Care and the patient pathway
It’s one thing what science and regulations approve, it’s another thing what patients need and want. I remember a year ago when remote nursing was still pretty new in clinical trials, I was contacted by a sponsor who was struggling with patient recruitment and retention in one particular country – Poland.
The sponsor wanted to provide the best support to patients and ensured remote nurses would administer the infusion in the peace of the patient’s home. Despite this setup, recruitment was not going well there and they were wondering why.
After speaking with the local communities and a few patients we found out why. These patients had usually been living with the disease since early childhood and by the time they were adults they had got used to going to the hospital once every week.
They were close with their doctors and felt much safer when they visited them instead of welcoming someone new at home.
This is just an example of how careful we need to be with what we think patients want and what they actually want. Patients have priorities and needs and only by knowing them, you can ensure you are on the same page and make the right decision on how to set up the trial to meet their expectations.
There are multiple ways you can find out about what patients need:
- Speaking to a local community and getting their thoughts. You can reach out to them directly but if you need guidance and support there are organizations like EUPATI who have built relationships with these communities and recommend the best partner for your study and questions.
- Assessing the standard of care in the country (this is also something that TrialHub includes, as well as providing trial volunteers insights.)
- Doing social listening, market research surveys, and other services in the field.
- If you are from a pharma, you can just reach out to your marketing/commercial colleagues and they usually have a detailed analysis of the patient pathway.
Investigators with experience
You can find out about what patients prefer through their physicians as well (of course in a different perspective). Speaking to an investigator who has been involved previously in a virtual clinical trial can save you a lot of time and money because they will have an overview of both endpoints/data collection and also how patients feel about it.
The challenge here is to find such an investigator with experience in the indication or TA and at the same time the virtual trial component. This is where TrialHub can help again thanks to our global database of virtual trials.
Another reason you should consider investigators with experience while planning virtual clinical trials is because you might want to avoid any friction in your startup and later on too.
Once the investigator is familiar with a given technology, he/she is better prepared to start using the same for another trial without the learning curve and the negative feeling of “I need to learn yet another technology”. This allows investigators to also be better prepared when patients have more questions.
And I write this in capital letters because at the end of the day each technology or solution comes with an additional cost. Especially clinical trials that have the flexibility of providing choice for the patients in what way they want to participate (which is the future of trials).
The same applies to hybrid trials because you have the remote setup plus the traditional site support. To that point, everything new and not adopted at scale is more expensive. I am confident that with time all these technologies will become more mainstream and will decrease in cost.
On the other hand, what does cost mean for a trial? The most important thing is to have a successfully completed trial which also means to be able to recruit and retain patients. Ask yourself what will be the cost of your delay or no ability to recruit and retain? It might be much higher than the cost of a virtual trial.
Let’s not forget that being able to provide better support to patients, to work with smaller practices and research-naive physicians, and collect data from all sorts of places and devices is a response to the growing societal demand and to the innovations in life science.
Knowing how to plan upfront and how to balance between the different options and technologies is key to meeting your expenses and ensuring your study’s success.
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.