The pandemic accelerated innovation around clinical trial decentralization, but remote approaches are here to stay. Here are five ways decentralization can help you succeed with your clinical trial.
In 2020, decentralization was the clinical research industry’s emergency response to the pandemic: clinical trials were halted, and we needed a way to keep moving. In a world that was shutting down to prevent the spread of coronavirus, the key to continuing our work was doing it remotely.
Sponsors, investigators and CROs shifted their approaches quickly. Clinical study protocols became more flexible, telemedicine visits replaced in-person visits, and patients started enrolling virtually. Clinical researchers around the world got creative and found ways to use technology to continue their work at a distance. This shift to remote approaches also accelerated innovation.
Two years on, it’s clear that decentralization is here to stay. Writing in Clinical Leader, Jessica Schell of IBM Watson Health Consulting noted: “Sponsors are discovering this more patient-centric approach (i.e., applying technology to provide better care, be more responsive, and reduce patient burdens) is also delivering improved trial efficacy.”
What is a decentralized trial?
In a traditional clinical trial, patients will usually go to a physical site and have in-person contact with investigators. This requires site visits, as we’ve seen in a previous post, and many of the processes a trial involves take longer and can be more complex in a traditional setting. For example, a location is needed, as well as staff, and patients need to travel to the site.
In a decentralized trial, the physical location is no longer the central point of contact – in fact, in many cases, the entire trial can take place remotely. Here’s an example of what that might look like:
A patient visits a community portal online to read about a clinical trial, then they fill out a screening questionnaire to enroll. They complete an informed consent form online and receive the study information by email. They then download an app to track their heart rate. They receive the patient kit or trial medication by post and follow instructions to use it. They provide the information the investigators need through the app. The data are sent to investigators along with GPS information, helping them analyze the results.
While there are still some challenges in setting up and running a decentralized clinical trial, there are substantial benefits. Here are five ways decentralization can help you succeed with your clinical trial.
1. It can help you make your trial patient-centric
Patients are key to successful decentralized clinical trials, but decentralization can also help you make patients the focal point. With decentralization, you design the trial protocol with the patient in mind: you think about what approaches would be most effective for recruiting and retaining patients, and how you can reduce the burden on them to ensure they complete the trial. Tools like online surveys, forms and questionnaires, electronic communication like email and chats, and apps and other tools for monitoring results can help keep patients engaged without overwhelming them.
2. It can help you stay flexible
One of the challenges associated with decentralization is setting up a study protocol that is flexible and still meets regulatory requirements. But this is also a benefit: in today’s unpredictable world, large, complex studies can face unforeseen problems. When you build flexibility into the trial design from the beginning, you are safeguarding the trial, giving you alternative options to reach your endpoint.
3. It can help you keep your trial on track
The flexibility you build into a decentralized trial from its conception could save the trial if there are external pressures. During the pandemic, lockdowns meant in-person contact had to be minimized for non-essential visits. Trials with remote monitoring in place were more likely to continue, as patients could continue to provide data without visiting the site. This applies to all aspects of a decentralized trial, from enrolment and screening to ending a study. By reducing delays caused by external influences, you can make sure your trial stays on track.
4. It can save you money
While decentralization might require investment in technology – such as apps for data collection and portals for engagement – as well as postal delivery for medication and equipment, it can also provide significant cost savings. Decentralized trials may not require a physical site, and you may need fewer staff. Depending on the technology used, data analysis could also be more efficient. With less time, fewer people and less space needed, costs could be much lower.
5. It can improve outcomes
When a decentralized trial is up-and-running using integrated, interoperable digital systems that give you real-time data, you can see patterns in patient behavior and adjust your approach accordingly. For example, using artificial intelligence that looks at the results of previous studies, you can predict how patients might behave or react before the trial starts, then monitor trends in real-time. This could help you improve adherence to the protocol, such as by changing the frequency of reminders via the app, or identify patients who need more support to use the technology.
Decentralized approaches may require more innovative thinking, investment in technology and flexibility, but they could help you succeed with your clinical trial.
Contact Siron Clinical to find out how we can support your decentralized trial.