Decentralized Clinical Trials Booming Rapidly in Pandemic- Why?

Clinical trials are the most crucial process to bring any biologic, drug molecule, or other medical products into the market. The complete process can be understood simply: I) Development of the biological molecule; II) testing it in animals; III) safety testing in small numbers of healthy participants (phase 1); IV) safety and efficacy testing in a small group of patients (phase 2); V) safety and efficacy testing in large numbers of patients (phase 3); VI) final regulatory approval and manufacturing followed by post-market surveillance of the product (phase 4). 

Indeed, the traditional clinical trial methods are well-versed, thoroughly regulated, and smartly invested and have supported the existence of healthy human life with a tremendous contribution to the healthcare market. From an ethical standpoint, these trials serve as pivotal support to ensure the product’s efficacy, compliance, and safety that helps regulatory decision making. In the current situation of a global pandemic, when COVID-19 has impacted nearly all segments of industries and businesses worldwide like nothing before exacerbating the social contacts widely, the time has come now to realize the fact that we are living in an extraordinary era where, "the notion of Decentralized clinical trials is no longer a mere notion" we can even expect these virtual models to become the new normal in the healthcare industry. 

Contrary to traditional clinical trials where participants need to make frequent in-person visits to a clinic or hospital, a Decentralized model allows healthcare providers to recruit patients, gain consent, administer treatment, and data collection without patients requiring to leave their homes. Decentralized clinical trials have the power to bring all important stakeholders of the trial, i.e. sponsors, healthcare providers and patients to one common dashboard with access to real-time patient data which could make the process more transparent between the sponsors and investigators in assessing the study data and its compliance and overall an improved relationship within the whole clinical ecosystem can be maintained. Concurrently, these virtual trial practices are more convenient for patients as it reduces the burden on the patient of visiting sites, with no longer need to keep personal data records manually that will predictably increase enrollment on studies and save significant time for both patients and clinicians. Currently, when all eyes are on the treatment and/or successful vaccine to make a foray into the market to combat COVID-19, apparently clinical trial awareness has gain significant momentum in our society, which shall help increase patients enrollment and engagement in future clinical trials.

For keeping the trial transparent and realistic, our healthcare providers are continuously working to overcome the challenges, let’s take a look what changes to expect with Decentralized trials practices

Figure 1: A few Identified Challenges and Mitigation using Decentralized Trials

In 2016, the United States Congress passed the 21st Century Cures Act, mandating the U.S. FDA to establish a program to evaluate the potential use of real-world evidence (RWE) for regulatory purposes. In 2018, the FDA published the framework on its RWE program. Now, as COVID-19 is wreaking havoc globally, all the regulatory agencies, European Medicines Agency (EMA), Food and Drug Administration (FDA), and Institutional Review Board (IRB) are supportive of pragmatism and encouraging the use of Telemedicine and Virtual visits to maintain patient’s safety and compliance of protocol altogether. Though early results indicates that adaptation of Decentralized model provides benefits to trial execution amid this pandemic situation where avoiding exposure to the virus is a prime factor in each and every consideration among several others, it would be fair to say these practices are not convenient for all therapeutic areas and indication as every study is different and requires a customized and strategic approach to ensure successful trial execution, keeping patients at the epicenter of all. Time, investment, learning & implementation of use-case scenario among all the stakeholders shall provide a clear path to practice Decentralized methods as we find alternates to traditional approach.