Recently, Maya Zlatanova’s article Decentralized Clinical Trials Across Europe: Regulatory and Other Practical Considerations was published in DIA’s Global Forum. The piece highlights the most important considerations for planning and conducting decentralized clinical trials in Europe – from the different ‘readings’ of EMA’s guidelines depending on the country to the mindset of the patients depending on their cultural background.
This got me thinking:
Planning a decentralized trial truly takes more than accurate historical data and smart analysis of the numbers.
If there is one area where CROs cannot depend solely on data for their RFP, it’s DCTs.
Yes, even with a traditional trial setup the professionals in the industry might need more than just numbers – site surveys are good to have in some cases and a must in others, and getting in touch with KOLs can make a proposal that much more compelling.
If you’re working on an RFP for a very specific patient population or TA, data is essential but additional insights will make you feel even more confident in the proposal.
Still, DCTs pose an additional challenge if all you have is data. Even the most recent, most accurate, most complete set of data.
On TrialHub you can find this “initial data” – meaning, you can filter for DCTs in your indication and learn a lot from their design. You can see which technologies they used and in which countries they were conducted, which investigators they worked with, how many patients they recruited, and even check out their delay in days.
This data is a lot harder to find on your own, especially on this scale and in the time you have to submit a proposal. In the registries, you are limited to only looking at one trial at a time and going through a lot of trials until you find one that is relevant.
Thanks to NLP (natural language processing) TrialHub identifies all trials relevant to your protocol and analyzes them to give you key metrics. What’s more – data from the planning stages of a trial is no longer available in the registries, meaning you cannot readily assess trial delays. Trial delays are essential in order to discuss realistic timelines – this is why we compare data from the planning stages of a study to the actual results in terms of recruitment, sites opened, and delays.
This is already a great help, still when planning a DCT even country feasibility can be tricky and this is even more so in Europe.
Let me give you an example/thought experiment.
Say you are tasked with planning a decentralized trial in Eastern Europe and the trial needs to include home nursing solutions. Home nursing solutions for clinical trials in Europe are more limited than in the States with some international providers covering areas via local offices. In Eastern Europe in particular, there are few options (btw, you can check out providers in our Guide to Virtual Clinical Trials).
You might have to be creative and come up with unorthodox solutions in order to cover some areas. To design a robust strategy, you need to know who your partners can be (both in practice and in terms of what regulations allow) and how to find them.
Moreover, you need to know how your target patient population would respond to a healthcare visitor in their home. Are elderly patient populations in Eastern Europe open to receiving treatment and being monitored at their home? Even if in theory it sounds like convenience, you may find out that some patient groups prefer to visit a hospital or are suspicious of visitors.
There is a vast database of knowledge that only exists in the minds of local experts who have the experience, observations, and background cultural understanding to support your clinical trial strategy.
Getting in touch with local experts is not always easy.
The administrative burden alone can dissuade a lot of feasibility teams from reaching out. And the looming deadlines make matters worse.
This is the issue our team at TrialHub set out to solve with CAN. Our Country Advisors Network exists to support feasibility teams with additional insights that data alone can’t provide.
Let’s circle back to our example. How would CAN help in this case?
To begin with, a local expert can provide information about the regulatory landscape in the country – including who and how you could partner with to support patients remotely, which technologies you can and cannot use to ensure data privacy, and if patients would actually use them depending on their technical literacy and personal preference.
A local expert can provide a lot of valuable information about the specific patient population and their potential willingness to participate in a DCT depending on the trial design. As for remote data collection, local experts are the ones who can advise you on best practices that balance regulatory compliance with patient comfort.
To obtain all of this information on your own, you would have to become an expert in the Serbian clinical research regulations landscape, the Romanian healthcare system, and the Polish patient pathway in the span of about 10 days.
CAN saves you a lot of time on research and it comes with TrialHub – meaning, you only sign a contract once and you don’t need to go through another vendor qualification process to get in touch with one or ten local experts. If you are interested in how TrialHub CAN support your clinical trial strategy, just shoot me a message.