COVID-19 Transforms the Clinical Trial Industry Ecosystem

We all remember the emergence of COVID-19 during the first quarter of 2020.  As the virus spread and infection rates spiked enrollment within most clinical trials stopped – apart from COVID-19 vaccine trials.  Between March 2020 and May 2020, all ongoing trials scrambled to continue visits at home or attempted to reschedule visits for patients already enrolled during restricted days/hours at facilities that were either locked-down or under restricted hours. New patient trial activity virtually stopped.  Further, an April 2021 BMC article noted the impact of COVID on clinical trial initiation in the United States, where only 57% of the expected historic average of trial initiations occurred.

Trial initiation decreases were related to some trials being deemed too risky to initiate in the unknown COVID environment, or because of many potential trials volunteers shying away from visiting hospitals or healthcare facilities for fear of the increased risk of contracting the infection.  In addition to well-founded fears among would-be trial participants, many healthcare facilities were drastically re-allocating resources from other services (including clinical research) to managing care for a tidal wave of COVID-19 patients.

In the wake of COVID’s catastrophic impact on the way we conduct clinical trials, industry leaders in collaboration with regulatory authorities began mapping out a greater transformation of the clinical trial industry in response to these events.  On the leading edge of this transformation was digital technology. “We have been on the cutting edge of innovating technology platforms designed to improve the design and implementation of clinical trials for decades,” said Mike Keens, Executive Vice President, Anju Software.  “If there is any positive that came from COVID, it’s that the clinical trial industry was forced by circumstance to more fully integrate these tools and approaches.”

Many digital technologies to help improve clinical trial efficiency and speed have been in existence for some time, but sponsors have been too conservative or set in established approaches to more fully adopt them.  The advent of the global COVID-19 pandemic has forced the issue, and today these technologies are being deployed with a high level of safety as well as acceptance and encouragement by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This is particularly evident based on recent FDA and EMA issued guidelines regarding the use of these new technologies.

The Digital Trial Replaces the Clinical Trial

As we emerge from a post-pandemic world, the old way of conducting clinical research will be outdated and insufficient.  The industry will evolve into the design and implementation of hybrid and synthetic clinical trials relying heavily on Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO) platforms. “We have been at the leading edge of data capture for decades with our TrialMaster electronic data capture software,” said Suhas Gudihal, Chief Innovation Officer, Anju Software.  “Our EDC is easy to use for both patients and trial sites, which is vital as the market relies more on decentralized trials.”

Utilizing EDC software platforms has enabled clinical trial sponsors to resume their research programs during the COVID pandemic.  But not all EDC services are positioned to handle the tidal wave of data generated by these digital and synthetic trials.  “The era of EDC-generated databases is out,” Gudihal explains.  “Our innovative software technology also delivers data lakes, which are digital environments that not only receive the high volume, high-velocity data -- but can integrate these disparate data sources and provide analytics for rapid decision making.”

The increase in electronic patient-reported outcomes (ePRO), has resulted in the exponential increase of data flowing into clinical trial data lakes.  Date from wearables, such as iPhones, Fitbits, at-home echocardiograms, heart rate data, and glucose data, all originating from, and transmitting at high volume and high velocity to clinical trial sponsors.  Layer onto this the deluge of other large radiology-based image files, and telemedicine video files -- the challenge of data management can make or break a clinical trial.

Data Integration Sets the Standard

A vital element to the implementation of decentralized or, if you like, digital trials, will be rapid data management and the critical ability to integrate these data.  With data being generated from many different sources in many different forms, it is imperative a sponsor’s software integrates these data or risk the process slowing down.  Data lake providers that can also deliver the ability to integrate data have become the standard.

Decentralized clinical trials must utilize SMART on FHIR (Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources).  The use of SMART on FHIR enables the translation of data more rapidly into data lakes. Utilizing FHIR is only part of the solution – storing the data and translating the data into usable analytics is another key element.  After the data is efficiently integrated, linked, and mapped, a sponsor can easily run analytics to uncover key insights to drive the next steps.  “We call this the golden record,” says Gudihal. “These data can uncover reasons behind why enrollment is low, why adverse events have spiked, or why certain trials are experiencing delays. Answers to these questions in real-time can accelerate trial completion and reduce trial costs.”

As we move into the post-pandemic future where pharmaceutical and biotechnology innovators must move clinical trials forward, the industry must embrace expanded technologies and capabilities.  Offerings in these areas by Anju and others enable the successful use of these expanded technologies to facilitate the patient, drug development, and medical advancements possible with enabling decentralized and digital-focused clinical trials

Chief Innovation Officer; Co-Founder, Anju Software

Executive VP Operations, Anju Software

Anju Software, such as TrialMaster, provides robust digital technology platforms to enable cutting-edge decentralized, digital and synthetic clinical trials.