Defining the new age of clinical development: How COVID-19 is rewriting the rules for testing and trials

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June 17, 2020

Read the Article on MedCity News

By Sheila Rocchio

I’m tired of hearing the phrase, “after-Covid.” We know that in the next few months the first major wave in North America will be over, but there is no going back to the way life was on March 15. Certainly not immediately, and maybe not ever. There’s no magic switch that will allow us to go back to some semblance of normal life. Other than a vaccine.

I can’t remember any health crisis that has so unified the pharmaceutical industry. Just about every major company in the world is working on developing an immunization, and everyone—from universities to government regulators—is on board to try to expedite the discovery and production of a Covid-19 vaccine. This singular focus is fundamentally altering how clinical trials are conducted and how regulatory approval is granted. There’s never been anything like this since the passage of the Pure Food and Drug Act in 1906.

As we grapple with the ongoing impact of Covid-19, we’re experiencing fundamental changes in how organizations in all industries operate, what that means for shifting workflows, and even how people manage their everyday lives. The pandemic is pushing global economies and infrastructures into brand new territory, and there is no real roadmap to guide us. Though that may be a terrifying thought, our current challenges have actually started to produce innovative solutions and improved processes across all industries. Nowhere is that more apparent than in the pharmaceutical world, where the focus on finding a treatment for the virus has forced novel approaches to how clinical trials are managed and delivered.

Speed and access are the driving forces behind this innovation in the race for a cure. Before the pandemic, complex global clinical studies would take months to set up; now, Covid-related trials are up and running in a matter of days. And though mobile and virtual trial models and technologies were already being used to increase patient recruitment and engagement, physical distancing requirements have only ushered in the more widespread adoption of trial virtualization. Maintaining oversight of clinical sites while ensuring health and safety has also called for central and remote monitoring as these are the only options. From patient recruitment to data collection, every phase of a clinical trial has been forced to evolve because of Covid-19.

As we hopefully move closer to finding a vaccine for the virus, what if this sense of urgency and focus on innovation could be applied to all clinical research? Are there lessons that we can carry forward after the pandemic?

If we’re not considering these questions now, then we’re doing a disservice to the thousands of people who have had their trials paused for heart disease, cancer and other diseases. Because, while treatment discovery for Covid-19 is progressing rapidly, clinical development has stalled significantly for other ongoing trials, with more than 60 percent of trials halted or in the process of being halted. In the U.S., 440 studies—and counting—have been suspended since March 1 because of the pandemic. Approximately a quarter of the studies put on hold are for cancer treatment, which could have involved as many as 200,000 people.

Connecting patients to researchers, no matter where they are, is now more important than ever. Setting up trials with telehealth, at-home visits and wearables that can monitor and collect data seamlessly from patients are all crucial tactics in lowering the barriers to patient participation, engagement and safety. While these methods tie into the trend towards precision medicine and may ease concerns over possible exposure to the coronavirus, they also add complexity to clinical trials operationally. With data coming in from such varied sources, sponsors must look towards better digital strategies and technologies that can quickly and intelligently process information for immediate study insights.

This means that advancements in clinical development depend heavily on how the pharmaceutical industry further leverages digital capabilities and automation. Information that is increasingly collected remotely must be mapped, standardized and reviewed efficiently. Even before the pandemic, the increase in external data sources was an issue for life sciences companies. As noted in an October 2019 Gartner report on how life sciences organizations were meeting clinical data challenges, 46 percent of life science CIOs said that business intelligence (BI)/data analytics capabilities would receive the largest amount of new or additional investments.

As with the studies being conducted for Covid-related therapies, compressed timelines are vitally important to clinical research as a whole. Technology platforms that can automate these processes will reduce the manual effort needed in performing data management and analysis. Efficiency through automation is precisely the benefit afforded by the implementation of new technology in data-related tasks versus relying on traditional methods like Excel spreadsheets and file-based solutions. It’s about providing rapid access to new data streams via one centralized version of the truth to the right stakeholders at the right time for collaboration and proactive decision-making, enabling new drugs and treatments to gain approvals with minimal delays.

We may not have been ready for Covid-19, but with advanced analytics, data collaboration and the right infrastructure, we can certainly be better armed in meeting the next global outbreak head-on.

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