Yahoo Finance How the pandemic spurred reform of clinical trials in drug industry
Bias in clinical trials is one of many shortcomings the U.S. health care system uncovered by the coronavirus pandemic — and advocacy groups are calling for more diversity in trial participants moving forward.
The federal government has started to take steps in recent years, with a Clinical Trial Diversity Toolkit published by the National Institutes of Health in 2016, and a call for greater diversity on a page published by the U.S. Food and Drug Administration.
During the COVID-19 vaccine trials, Moderna (MRNA), which was the first company to start clinical trials, slowed its enrollment for the final stage of trials in order to ensure a more diverse participant pool. Other companies, including Johnson & Johnson (JNJ) and Novavax (NVAX), conducted global trials to provide a level of diversity.
The largest industry lobbying group, PhRMA, is slated to host a workshop in June to discuss "participation barriers" and ways to "enhance diversity" for clinical trials.
And some companies are vocal about the need to change the system.
"It's incumbent on us to ensure that when we study our medicines, that those medicines are studied in the representative patient populations that they're intended to treat. Historically, that's not been the case," Dr. Andy Plump, president of research and development at Japanese pharmaceutical company Takeda (TAK), told Yahoo Finance in a recent interview.
Remote participation
The pandemic forced some companies to adopt a strategy they had been too cautious to pursue in the past, but could play a vital role in diversifying trials: remote participation.
The idea that a decentralized clinical trial setup, with engagement from physicians rather than institutions, could help encourage a more diverse participant pool, has already been attempted by firms like TrialSpark. But the idea that it could be done remotely, and thereby expand access, wasn't a popular idea pre-pandemic.
That has since changed, and companies that can provide the necessary tech platforms can see the shift.
Derk Arts, CEO of software firm Castor EDC, saw the opportunity and hit the jackpot when the World Health Organization (WHO) was searching for a better way to run the most important trials amid the pandemic.
"The entirety of this business process is not data-driven at all," Arts told Yahoo Finance recently.
Securing the WHO contract was a result of a proactive outreach and luck, Arts said. The WHO was struggling with its existing platform at the time he decided to reach out to the principle investigator to pitch his company. With the addition of the 50,000-plus WHO trial, it meant the small company had to suddenly scale, and very quickly, to meet the demand.
"Within a week, we basically had the entire trial move on our platform and running. Almost no other competitor would have been able to pull that off," Arts said.
He believes that if contract research organizations, which are clinical trial sites that partner for federally-funded or pharma-funded trials, take the initiative to ensure remote monitoring and other tech-based tools are available, they will be prepared for the future.
"As soon as the (trial) sponsors start demanding that, they need to be in the right place. I think it's very likely they will look elsewhere for a more technology-focused partner who can kind of help them," Arts said of companies who are likely to start look for ways to bridge the diversity gap.
The contract with WHO has put Castor on the radar of Big Pharma. "It's definitely also just been driving a whole new customer segment to us. Where previously it would be very rare for big (clinical trial sites) or big CEOs or big sponsors to reach out to us, now everyone's saying, 'Wait, this company is making waves and making a difference,'" Arts said.
Future outlook
Castor opened up its platform for free for COVID-19 trials in February 2020, and is now supporting 300 trials. To-date, the company has completed 2,000 clinical trials, with about 4,000 currently under way.
Takeda's Plump believes the industry at-large is now focused new ways to conduct and monitor more diverse trials.
"I think that what we've seen over the last year is, in a sense, a jumpstart to something that we've been trying to do for many years, but now I think we're supercharged," he said.
To support the enthusiasm, a combination of industry action and federal engagement are necessary, with the a need for mandates or new regulations in some cases, Plump said.
But, he added, "mandates are less effective than the guiding principles and alignment of a sector, because mandates, as you know, sometimes drive bad behavior."
Still, now that the industry has had some experience with the concept, it is likely to start building forward. But it's not as simple as just ramping up what was put in place during the pandemic.
"I wish it was so simple," Plump said, noting that new relationships will need to be built in order to truly diversify.
To achieve that, Plump said, building trust in diverse populations and ensuring language in informed consent forms reflect inclusivity are the first big steps.
"Many of those trial sites don't access patients in the representative way that we're looking at, so it requires building out new relationships, new clinical trial sites....I think that's going to take time if we want to do this in a way that's foundational and lasting," Plump said.
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