A virtual clinical trial, also known as a decentralized clinical trial, is comparatively a new method of conducting clinical trials virtually. In a true sense, a virtual clinical trial has no physical interaction during the entire process. Technology plays a major role in a virtual clinical trial. Different patient-facing technologies like wearables, electronic monitoring apps, online social engagement platforms, etc. are used extensively during a remote clinical trial. The idea of a virtual clinical trial has been around for some time, however, it has never been a popular path for sponsors. As we know, a clinical study is largely based on data. And still, personal health data goldmines like wearables are not tapped much, although the first Fitbit has been around since 2009.
However, the scene is changing with the COVID-19 pandemic breaking out worldwide, and social distancing becoming the new normal. Sponsors are considering incorporating different ‘siteless’ elements in traditional clinical trials. In fact, in many cases, a virtual clinical trial is quickly overriding the traditional method.
How can you enable your virtual clinical trial with technology?
There are several ways to virtualize a clinical trial. In this article, we will explore a few areas. These include:
From smartphone apps to wearables to e-diaries, multiple gadgets can serve as a goldmine for personal health data. A virtual clinical trial can be done with the ease of data collection leveraging these gadgets and gizmos that are available and used by the masses frequently. Using technology, the whole process of data collection and sending it for analysis can be automated.
Patient recruitment is a critical and often time-intensive procedure in clinical trials. Right from identifying patients, recruiting, and getting them enrolled is a mammoth task. Patient recruitment accounts for 30% of the Phase III failures. But with a decentralized clinical trial process, patient recruitment can be expanded significantly. Patients can be at home and still participate in the process, they can avoid visiting the sites which are much needed at this time of the pandemic. This also means that the patient enrolment time will speed up given that patients don’t need to travel to a site to give their consent. Additionally, social media can be leveraged for patient engagement. This is a golden goose since half of the population is on social media already. AI-driven tools can be brought in to target the global patient pool.
Five key challenges of virtual trials
Like any procedure, virtual trials have a few challenges. These are:
1. Data privacy
Data privacy is one of the biggest concerns in the internet world. With tons of data available at the fingertip, it also exposes it to the risk of data theft and breach of data use. The sharing of a patient’s health data and biometrics in the digital world is a concern. Further, with no medical staff involved in some virtual clinical trials, it means patients need to take care of receipt and storage of IMPs, entering and transmitting their data, dosage adherence, and much more.
How to overcome it?
While sponsors need to invest in the right data protection technologies, they also need to ensure that patients are taught to manage data handling.
2. Quality of Data
Quality of data or data integrity is another concern for sponsors while conducting virtual trials. Without any clinicians present at the patient’s home, there is a fear that trial patients might not receive the ideal standards or treatment or there might be noise in the data.
How to deal with it?
This is a genuine challenge, however, it can be overcome by adopting technical and data standards utilizing technologies like application program interfaces (APIs) and Machine Learning (ML). These approaches will help to make the data portable with validated endpoints.
3. Finding the right technology vendor
Not just technology, but finding the right technology provider can be a challenge too. You may choose a big technology vendor or a smaller company depending upon your company size, but what matters most is the vendor needs to be equipped with the right technologies that you need for your virtual trials.
How to overcome it?
It is a wise idea to run a small pilot project or secure a free trial (if available) and assess the vendor on various parameters like EDC, CTMS, randomization, supply management, etc. This will help you to understand if the company would be able to meet your requirements. Run a small pilot project with the vendor company to make an informed decision.
4. A Conservative Approach
Sponsors always have a conservative approach when it comes to taking the virtual route to clinical trials. The major reason for the conservative approach is due to the quality of the data that is generated offsite.
How to overcome it?
With the data standardization process in place, it is possible to standardize the data quality and thus get access to more reliable patient data.
5. One size doesn’t fit all
In virtual clinical trials, it is important to remember that not one size fits all. Every trial setting has to be unique because the patient population is unique and so is the data. Hence, it is important to customize the operational format to ensure that the study is a success.
How to overcome it?
Sponsors need to look into each trial separately and adapt to an optimized study model by leveraging the right set of technologies.
The pandemic has forced sponsors to reconsider the future of clinical trials and adapt to the new situation. Many sponsors are looking into investing in patient-centric technologies amidst the pandemic that hit the world. It seems that the only way to move forward now is to leverage different technologies and tools and adapt to virtual clinical trials. With cost-effectiveness and potential for greater patient enrollment and retention, the future of virtual clinical trials is promising.