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Traditionally, clinical randomized, controlled trials required an enormous investment of upfront money and time for the very preliminary stages of the study such as the design, identification of clinical sites, and patient recruitment. This means that there we are beset with too many complexities before even ascertaining the viability of a study. 

The integration of various digital technologies such as cloud computing, artificial intelligence, big data, wearable devices, remote monitoring, and virtual clinical visits are now hitting the limelight, as pharmaceutical companies use them to accelerate digital trial processes through improved patient engagement, reduced trial failures, and profitable drug development. In this article, we’ll see how these virtual technologies can make clinical trials more efficient, easy, and profitable. 

Challenge with the Traditional Approach

Patient engagement is much more than a formality, it’s an art. Patients find it daunting to participate in clinical trials due to the fear of the unfamiliar, which arises due to a lack of clarity on the means or purpose of a trial. The social distancing norms and quarantine regulations of today will make patient engagement more challenging, as the pandemic interrupted roughly 80% of non-COVID-related trials. 40-50% of clinical trial sites fail to meet patient enrolment targets, leading to a loss of $ 8 million every day due to trial delays. 15-30% of patients drop out of clinical trials, which leads to a loss of $ 12 million in additional efforts to support further patient enrolment. These trends suggest the need for a change DIGITALLY in the way clinical trials are perceived and implemented.  Why the digital route? Let’s dive in and explore. 

Why go Digital 

Technology has changed the way we communicate and conduct affairs today, ever more profoundly than what one would have expected at the dawn of this century. A Digital Clinical Trial offers a virtual paradigm, a platform in which many aspects of clinical trials can be improved – this includes recruitment and retention, data collection, and analytics. It provides an important opportunity to accelerate the pace at which we generate evidence through clinical trials and improves trial efficiency by supporting investigators and study teams to conduct trials without any in-person visits or tricky meetings. This, in a way, also manages to keep those vulnerable safer from being infected with COVID-19 or other dangerous infections. 

The potential that the technology has for clinical trials has been recognized by the United States (US) National Institute of Health (NIH) and the National Space Foundation (NSF). Notably, these renowned institutes held a workshop in April 2019 in Bethesda, Maryland, bringing together experts in clinical trials, digital technology, and digital analytics to discuss the future of digital technology in clinical trials. 

Data Collection, an Overview

Digital health technologies are already hitting the limelight, thanks to the many devices that track our physical activities, sleep rates, medication adherence, etc. Not many of these magical technologies have been developed for the purpose of research, though, and some of them need to be evaluated and validated further before being implemented in a clinical research setting. 

However, the digital world presents the healthcare research community with tools that can improve the quality and efficiency of the clinical trial enterprise. For example, in and out-patient data collection is not anymore paper-based. The process is now done with EHRs – real-time digital records that come with a repository of data such as patient diagnosis, treatments administered, laboratory tests, and other relevant details. EHR-based clinical data also brings with it the potential of enabling major trial components such as planning and design, site start-up data, and clinical events follow-up. 

A framework recently released by the FDA (Food & Drug Administration) for real-world evidence generation suggests a strong interest in collaborating on pilot studies that make use of EHRs and other real-world data sources. While this technology can definitely revolutionize many aspects of trial management & operations, multi-stakeholder collaborations can help in overcoming the many barriers that the technology presents, which includes sub-optimal accuracy and completeness of data collected by the technology, privacy concerns, and platform interoperability challenges. 

Digital Recruitment & Retention in Clinical Trials 

The conduct of clinical trials, and their timely completion, requires systematic recruitment, informed consent, and retention of participants. Lack of retention may also arise from poor understanding (again due to poorly executed informed consent), lack of remuneration, and other associated concerns or fears. 

Digital interventions can address these challenges in various ways – which includes tracking applications to allow for more efficient participant outreach, improved opportunities that encourage participants to take part in trials out of research centers and in zones where they are most comfortable with, and the use of video and other interactive formats to aid informed consent. Online assessments, data captured by wearable devices, remote monitoring, and virtual clinical visits also reduce patient burden, which will have a positive impact on recruitment & retention. 

Trends That Hold Promise 

We now know that the digital landscape offers vast potential to the clinical trial segment. This has been made possible by the many technological streams that constantly produce mind-numbing possibilities. Consider these:

Cloud computing and Telehealth can help design an integrated clinical study where real-time patient data is collected to shape outcomes. Artificial Intelligence (AI) can enable functionalities such as electronic data capture, electronic patient-reported outcome functionalities, and adverse events reporting. Combine AI with deep learning, you get to easily gather genomics data and other information from various sources, including past clinical trials and journal articles. Companies could also have access to real-time health analytics through a dashboard that tracks different performance criteria.

Wearable devices, combined with mobile technology, are capable of monitoring heart rate, movement levels, sleep rates, and other vital medical signs.  These devices improve patient experience, as the automated tracking feature takes away the burden of recording their health aspects manually. Its real-time data collection feature enables the research staff to devote more time to the research aspect by cutting out data entry. The enormous data gathered by these devices would also help researchers come up with accurate analysis and robust data collection. 

Small and sophisticated sensors are now being designed to cater to the clinical research market. They could serve their purpose in developing digital signatures that indicate how people with a particular disease may behave. Such comprehensive data capture capabilities could facilitate the implementation of just-in-time interventions, as and when needed. 

The Virtual Advantage for Researchers & Patients 

Virtual Reality, a branch of immersive technology, is proving to be a major boon for clinical research settings. Its gamified way of immersing users into a world so designed offers an engaging way to introduce patients to clinical trials. The role it plays is to simply take everything mundane out of a physical setting – such as the paperwork, the meeting with the physician, the walk-through of an upcoming procedure, or training of a medical device, and make it interesting and interactive. 

The virtual platform takes away the fear factor, which results in increased trial participation and a willingness to engage. The technology’s ability to collect real-world data also allows physicians to gather deeper patient insights by observing what patients do, than what they say they would do.  The realistic simulation it provides helps them better understand the best practices and techniques for treating patients and ensures a more controlled application of independent variables. 

Healthcare specialists across the UK are testing a VR system developed by Oxford Medical Simulation that trains doctors and nurses to recognize extreme cases of diabetes early on and start administering treatment at the earliest. Another group of scientists, led by the Italian pharmaceutical company Dompé farmaceutici, are trying to use the technology to find a therapeutic cure for COVID-19. They recently succeeded in submitting their first candidate for a Phase III clinical trial in Europe: a generic osteoporosis medication called Raloxifene.

“We’re waiting for the final results, but we are very confident on the possible success of the clinical trial,” says Andrea Beccari, lead scientist at Escalate and head of research and development platforms at Dompé farmaceutici. 

Barriers 

With benefits come challenges, as every coin must have two sides. The first and foremost of them would be to bridge any digital gap and ensure that both researchers and patients are tech-savvy. Another main challenge includes the control, usage, and storage of investigative treatments sent to patients. Alexander O’ Leary of Clinical Trials Arena expounds on a situation where there is a power interruption and the refrigerator that houses the investigational treatment stops functioning: 

“What happens if a wearable suffers a technical malfunction? The device cannot be easily replaced – at best, delivery of a new device is hours away, and that is once the patient and the study team know it has a fault.”

Besides all that, data security is always a major challenge. While digital health technology is known for its intellectual data collection capabilities, it has also created new challenges to battle in terms of securing the privacy, safety, and regulations of the data so collected, transmitted, or stored. For this, I’m sure we can take a leaf from the FDA’s book, as the regulatory body has embraced cyber security as a component of medical device certification. 

Future Predictions

The threats, and the fact that the very digitization of the process is at its initial stage, do not overscore the vast potential that the technological realm holds for clinical trials. A survey by ERT points out that 33% of people were conducting virtual trials prior to the Pandemic, 75% confirmed that they were using some virtual elements, and 7% were going fully virtual. While we don’t have any statistics to suggest how the post COVID situation would pan out, it can safely be assumed that the trend is not just here to stay, but expand with burgeoning possibilities. Such a growth trajectory will require biopharmaceutical companies to collaborate with technology solution vendors so that they could reap the benefits that the various digital solutions bring into play.