Clinical Trials: The Hard Work Behind Vaccines, Therapies

CEO of Buffalo-based Circuit Clinical discusses the work that goes in the development of vaccines, devices and therapies. “All Americans should be proud of Operation Warp Speed,” he says

By Jana Eisenberg

Cardiologist Irfan Khan, CEO of Circuit Clinical, in Buffalo: “This could be a golden age for discovery about how to bring new medicines to market,” he says.
Cardiologist Irfan Khan, CEO of Circuit Clinical, in Buffalo: “This could be a golden age for discovery about how to bring new medicines to market,” he says.

The COVID-19 pandemic has increased many people’s awareness of clinical trials, as we’ve all waited with bated breath for a vaccine for the novel coronavirus, while experiencing the worst public health crisis in most of our lifetimes.

While clinical trials may not have been a common conversation topic before March 2020 for most, interest in the process has also increased.

Irfan Khan, a cardiologist by training, is the CEO of Buffalo-based Circuit Clinical. The thriving company he founded in 2015 was originally meant to increase participation in and access to clinical trials for all Americans.

One way it does this is with its proprietary platform, TrialScout (“Yelp for clinical trials,” he has called it), where people can go to research and rate clinical trials.

To explain the broader picture, and importance of clinical trials, Khan describes the “journey” that every medication must take before you or your loved one swallows, inhales or is injected with it.

“Clinical trials are the way that the FDA — which is charged with keeping us all safe — tests new products. Early trials of the [medication/device/therapy] with smaller groups of people test if it’s safe,” he said. “In the next phase, larger trials are done to prove that it has a positive effect. The whole process can take up to 10 years and cost up to $1 billion. And that’s true for every single medicine we take.”

Why is it important that people are aware of trials?

“The core idea is that everyone should view participation in a trial as a care option,” he asserted. “When more people have the opportunity to participate in trials, it’s good for all of us. Lack of awareness and participation is one reason it can take 10 years to bring new medicines to market.”

Why should people trust trials? “We need to continue to educate people on the safety and protections built into trials,” he added. “Everybody worries about participating; many think that they are being used as guinea pigs. But participants’ safety is first and foremost: everything is monitored and their input is valued and listened to. Rather than being experimented on, it’s like being part of a discovery mission. The participants are active at the front and center — they are the point of the endeavor!”

In addition to possibly receiving treatment and being part of the discovery process, other reasons that people choose to participate in clinical trials can include a sense of the greater good — the research that is done today could benefit themselves or someone else in the future.

Another way that Circuit Clinical increases opportunity for individuals to participate in clinical trials is by partnering with regional doctors’ offices and medical groups to conduct trials. This allows patients who opt in to a clinical trial to receive the trial-related clinical care where they receive their medical care, rather than going to a separate research facility. Trials can also provide people who may not have the means to afford it access to cutting-edge treatment.

What about people who might not be eager to receive a coronavirus vaccine, once they have been approved and are available?

Khan points to Operation Warp Speed, the federal program that poured funds into pharmaceutical companies to aid in the research and testing possible new formulas to immunize millions of people against the scourge.

“Operation Warp Speed may be the most ambitious American undertaking since the Manhattan Project, and it’s unfortunate that we’ve ended up in a climate that has politicized science,” said Khan. “Every American can be incredibly proud of this effort, which has produced not one but two vaccines. For people who are not sure they will take the vaccine, it’s important to remember that quality and safety were the No. 1 concerns of Pfizer, Moderna and AstraZeneca; the best and brightest minds and companies were working quickly on problems and solutions, yet they did not sacrifice any part of the process.”

“Pragmatically optimistic” for recovery from the pandemic, Khan believes that with some organization and cooperation, it can be overcome. “We’re on the right path,” he said. “We have a set of great vaccines — there are a ton of logistical issues. I know everyone is fatigued, but we also need to get back to basic public health practices: distancing, masks, washing hands.”

“I like to say we are one vaccine away from things getting back to normal,” he said. “I love to travel — when the vaccine is available and I can get it, I will be first in line! Everyone should feel hopeful that we are not done: there are a ton of trials that are looking at not just vaccines, but also testing and diagnostics. We will need options to get out to the billions of people who are going to need them.”

As for the bigger picture? “This could be a golden age for discovery about how to bring new medicines to market,” he said. “That’s the mission Circuit Clinical set out to serve.”