Drug Development in Wartime: Driving Tomorrow's R&D Decisions with Today's COVID-19 Data

June 1, 2020

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2020, Volume 29, Issue 6

The only way for pharma companies to know where to focus their COVID-19 R&D efforts is for the industry to have access to real-time, real-world evidence of what’s working to keep people alive, write Travis Leonardi and William Kirsh.

“In January 1942-a mere month after the attack on Pearl Harbor, Hawaii-President Franklin D. Roosevelt ordered the establishment of the War Production Board. Its purpose was to convert the factories of peacetime industries into manufacturing plants for weapons and military equipment for the fight,” according to an article from the U.S. Department of Defense. This was a time when all other U.S. manufacturing efforts virtually came to a halt to focus on our nation’s best interests. “To illustrate the magnitude of this transition, there were about three million automobiles manufactured in the U.S. in 1941. During the entire war, only 139 additional cars rolled off the assembly lines,” the DOD article says.

It’s certainly no exaggeration to say the enemy our country is facing today in the battle against COVID-19 is akin to a wartime adversary, and pharmaceutical companies are on the front lines of defense. In this ongoing war, what pharma companies need is real-world data right now, to make sure we’re continuing to produce the most effective weapons against our common enemy.

While industry and patients alike anxiously await a vaccine, life sciences companies across the globe are hard at work testing various drug therapies that could treat the virus or its symptoms and reduce the staggering mortality rates. There are many challenges when it comes to narrowing down what’s working and what’s not, and where to focus R&D efforts, especially when racing against the clock to prevent further loss of life. In addition to the timeline, pharma companies are faced with the fact that clinical trials on the ground right now are small, piecemeal efforts. We see clinical trials of only a few hundred patients being tested within a single

hospital, or at best, coordinated efforts among a few hospitals throughout one U.S. city. Clinical studies alone simply won’t arm us with the knowledge we need to be strategic in this battle.

Beyond the challenges related to participant number, age, and ethnic diversity that most clinical trials face-even in traditional, non-pandemic settings-the industry now must cope with resources and infrastructure breaking down. We have fewer and fewer staff members to devote to data collection and other trial protocols, shifting patient populations, no placebos in trials (rightfully) because of ethical concerns when patients are dying, and no time to waste. Although clinical trials are no doubt essential for finding the eventual vaccine we’re all hopeful for, what we need is real-time data showing what’s going on in hospitals across the country today, to help us make those in-the-moment decisions. The reality we’re facing is not one that can be put on hold for years or even months as we wait for clinical trial data to roll in. The only way for pharma companies to know where to focus their R&D efforts-and for clinicians to make the right treatment decisions on the ground-is for the industry to have access to real-time, real-world evidence of what’s working to keep people alive.

Fortunately, pharma companies and clinicians alike now have access to this evidence in a database that reveals survival rate data of more than 31,000 COVID-19 patients (as of May 10) from more than 500 hospitals across the U.S. Specifically, this real-time data report (updated daily) shows COVID-19 survival rate and length of hospital stay for patients on various drug regimens and combinations, across multiple cohorts, including sex, age, ethnicity, and comorbidities. In fact, major hospitals in New York City have already altered their treatment protocols based on this data. 

The benefit of the real-world data is that we can see the true efficacy of many drug treatments and combinations; not just those hyped in any given week. The bottom line is that we’re dealing with a crisis in which information changes almost day to day, and we need a way to capture that information accurately, on a national level. We have no precedent to learn from; all our knowledge is hindsight. And because R&D is such a time-intensive, costly process, the information we receive today can help shave billions of dollars and precious months off time-to-market.

The real-world evidence of today will become the drug therapies of tomorrow.

 

Travis Leonardi, CEO, and William Kirsh, Chief Medical Information Officer, both of Agilum Healthcare Intelligence

 

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