Late last week, Science 37 and AiCure announced a partnership that is now looking to support and deliver industry-leading technologies for virtual clinical trials. The companies, a market leader in virtual trials and an artificial intelligence (AI) and advanced data analytics company, are set to run a decentralized study in search of an investigational treatment for major depressive disorder (MDD). The trial will involve 150 participants and will implement the industry’s first and only platform purpose-built to support virtual trials.
So, as evidence now suggests that virtual trials are no longer a thing of the future, we take a look at the most significant developments in virtual trials and consider what they could mean for our industry today.
Pfizer
The first of these significant developments begins in 2011 with Pfizer’s REMOTE trial. Engineered to study overactive bladder disease, the research was entirely home-based for participants; with consent obtained online and documented by electronic signature, and the study drug delivered directly to the patient’s door. Monitoring was implemented via mobile devices and web-based measuring tools that would record adverse event reports and efficacy outcomes.
While this was a major breakthrough for our industry in learning what could be possible for clinical protocol, the study was, unfortunately, forced to stop due to a lack of participation. An article by Pharmatimes links the lack of success with a substantial worry among patients over personal safety in the trial and in providing their medical details online. The take-home here is that virtual trial operators need to make sure everything is done to ensure patients are comfortable with the technical aspects of the trial itself.
Sage Bionetworks
In 2015, Sage launched their mPower app that aimed to assess the natural history of the symptomatic progression of Parkinson’s disease. The trial consisted of 9,500 participants but, unlike Pfizer’s REMOTE, was only observational and did not include the administration of an investigational drug. Instead, the app used questionnaires and obtained sensor data from an iPhone and an optional wearable device 24/7, to continuously gather data on how a user’s capacities are affected by Parkinson’s disease. Capacities that were assessed included dexterity, balance and gait, memory, and certain voice characteristics.
The trial was paramount in showing how virtualization can source a wealth of wide-spread data on the lifestyles of patients that was never available until then. An entry in the New England Journal of Medicine contended that mobile health sharing has a powerful potential to accelerate clinical research, and that
“rapid sharing of data from a large-scale observational, such as mPower, [provided] a mechanism to distribute the task of developing appropriate analytical methods and identifying the approaches that maximize the utility of this new type of data.”
However, in doing so, the study also uncovered a lot of wider issues in the industry surrounding data collection and suitability. The same entry warned of ‘research parasites’ if the industry did not adapt and lay out extensive rules on the sharing of such data between research sites.
UCB and Science 37
Science 37 is on a mission to establish their virtual model in the industry as they’ve also partnered with UCB, a Belgian biopharma company, to deliver the company’s unique outcomes, provided by its patient value strategy, and the best experience to as many patients as possible. The partnership will see studies run and supported by UCB reinvented for the digital age - with several immunology trials redirected right to the patient’s home. The studies will be supported by a safe cloud-based mobile research platform called NORA, the Network Orientated Research Assistant; and, with the system adhering to the latest regulatory standards, this approach looks to fundamentally change how the company runs clinical trials in the future.
As this is a relatively new development, there isn’t much we can say at this point. Yet, the issues with data protection and distribution seem to be currently handled by companies, such as Science 37, in order for this type of trial to be commencing. In addition, the trial is set to make great progress in meeting diversity quotas as Science 37 claims its virtual clinical protocol has demonstrated greater diversity of participants and increased clinical trial efficiency and speed.
What is clear from the examples above is that a wealth of benefits for trial operators can be reaped from virtualization. Clinical trials are often delayed or fail due to difficulties with clinical trial enrollment, and it is evident that virtual clinical trials - especially in recent years - outshine their traditional counterparts in terms of recruiting successfully. Clinical research recruiters must also note that distance, disability, and the need for frequent in-person visits are major barriers to participation in clinical studies; with a study in Alzheimer disease finding that home visits were the factor most likely to enable greater participation in clinical research. The fact is that virtual site visits could reduce the time and travel burden of participating in clinical studies.
If we can deduce one thing from our three case studies, it is that the technology of virtual trials may now be ready to be implemented as the new norm. In a world that is now hidden away, unable to participate in live studies, this technology could be the answer that a lot of halted trials are searching for.
Yet, if we are to consider this a possibility, it is vital that the issue of patient confidence is addressed. Regardless of traditional or virtual methodology, a lack of patient confidence is recurring. Thus, it is of the highest importance for companies to work with partners who have experience in patient retention and are able to maintain close relationships with the patients during the very testing process of the clinical trial.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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