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

“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.¹

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 3 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. 

On April 5, Surgeon General Jerome Adams predicted, “This is going to be our Pearl Harbor moment, our 9/11 moment, only it’s not going to be localized.” A day later, on April 6, when the U.S. COVID-19 death toll surpassed 10,000, USA Today wrote that the number was more than the number of soldiers who had died on battlefields in six wars combined: The American Revolution, War of 1812, Mexican War, Indian Wars, Spanish-American War and Desert Storm.²

In the ongoing war against COVID-19, 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.

The challenges of clinical trials

While industry and patients alike anxiously await a vaccine, pharma 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. 

Travis Leonardi

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. 

“On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average,” according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA).³ Such a timeline just isn’t acceptable during a deadly pandemic.

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 trials alone simply won’t arm us with the knowledge we need to be strategic in this battle.

For example, the U.S. Department of Veterans Affairs (VA) study that showed no benefit and a higher death rate⁴ for patients taking hydroxychloroquine only included 368 patients, all of whom were male, and the small study in China that seemed to point to a lack of efficacy⁵ for Gilead’s remdesivir could not even enroll the 400 patients needed to continue the trial (which may be why that study didn’t show the promising results that the larger NIAID study revealed later). Over and over, we’re seeing these siloed, disjointed efforts and wondering why they’re not effective in helping us solve a global problem.

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.

Pharma manufacturers looking to create the right therapies to combat this disease only witness the tactics that are right in front of our eyes, with very little coordinated effort to see what is working in other hospitals and other cities miles away. We’re missing the forest for the trees. 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 that save lives now. 

Real-world data leads to real-time solutions 

William Kirsh

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. As recently reported by The Washington Examiner,⁶ real-world data on COVID-19 survival rates by drug treatment regimens is already being used by hospitals across the country as a “blueprint for coronavirus treatments.”

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 (and counting) from more than 500 hospitals across the United States. Specifically, this real-time data report⁷ (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. Interestingly, the recent breaking news from the National Institutes of Health (NIH) on the dangers of hydroxychloroquine (HCQ) and chloroquine (CQ) combined with azithromycin announced April 21 confirmed what this real-world data report had revealed several weeks before.⁸ 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 the media in any given week.

As another example, our expansive real-world data suggest that race is not an independent risk factor for death in hospitalized COVID-19 patients, despite increasing reports and media coverage to the contrary. A report from New York⁹ released May 6 found that most new COVID-19 patients are older people of color who have been in their homes; however, that data was gathered from only 113 hospitals over only a three-day period, covering about 1,200 patients – far fewer than our real-world database.

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, RPh, CP, is Chief Executive Officer, and William Kirsh, DO, MPH, is Chief Medical Information Officer, of Agilum Healthcare Intelligence.

Notes

1. www.defense.gov/Explore/Features/Story/Article/2128446/during-wwii-industries-transitioned-from-peacetime-to-wartime-production/

2. www.usatoday.com/story/news/health/2020/04/06/coronavirus-death-toll-us-reaches-10000-six-wars-combined/2949285001/

3.

4. www.cnn.com/2020/04/21/health/hydroxychloroquine-veterans-study/index.html

5. time.com/5826618/remdesivir-leaked-data-who-website/

6. www.washingtonexaminer.com/news/healthcare-analytics-could-provide-a-blueprint-for-coronavirus-treatments

7. agilum.com/agilum-releases-nationwide-covid-19-real-world-data-rwd-survival-rate-analytics/

8. www.prnewswire.com/news-releases/nih-and-fda-announcements-confirm-agilums-april-7th-real-world-evidence-rwe-of-covid-19-drug-treatment-observations-301047162.html

9. www.nbcnewyork.com/news/coronavirus/who-is-getting-hospitalized-for-covid-19-in-new-york-here-is-the-breakdown/2405077/