Video: Clinical Trials Research at Asthma & Allergy Associates
Daniel F. Soteres, M.D., MPH
We’ve had a clinical research center at this office for more than 30 years. I started here about 14 years ago, and have been heavily
involved in the research center since then.
It’s been a really important part of the practice, something I really enjoy. It allows me to be on the cutting edge of new science involved in allergy and asthma medications.
So there are several different levels of research–Phase I, II, III, and IV. Most of the studies we do are Phase II and III, where they’re really investigating a new drug, learning about how it works with the patients.
And Phase IV is after the drug has been approved, a company might want to figure out if there’s another indication for that medicine.
So we do all phases of drug studies. We do studies for respiratory diseases, like asthma and COPD. We do allergic rhinitis studies.
We do research with a rare genetic disease called hereditary angioedema, which has been a lot of fun for me.
I’ve had a lot of success in that area.
The medications in that space just became available in the past 10 years. And I’ve basically studied every new medication available to these patients. We do research in skin, dermatologic conditions like eczema, itching, chronic sinusitis.
So it’s been a lot of fun for us.
The number-one most important thing for research is a process called informed consent. That means you know what you’re getting into. And whether or not you decide to participate, we love you.
Many of the patients who participate in research are patients from our clinic. You do not have to participate in research. We try to be very clear with people. It’s an option.
Most people actually ask us, can I participate in a research trial?
After that, you get a booklet of information about the disease, about the medication, about the risks and benefits. In most studies, there is a placebo arm, meaning that there might be a sugar pill.
We don’t take away maintenance therapies that are keeping a person healthy.
So that’s the core thing, is informed consent.
After that, there’s a process of being involved in the studies, where you get called in. You might do breathing tests or blood tests to determine if you’re still a candidate for that trial. And once you’re in the trial, there’s usually one or two visits
in the first month, and then monthly visits could be six months, 12 months, or even some studies go on for several years.
I think the processes are the same. You have to be very detail-oriented. You have to be very clear with your patients about the process of informed consent, that they’re participating in a research trial.
I think the bottom line is really no.
You’re trying to find patients with a specific disease who meet certain criteria. When people go into research studies, their care for that health condition is probably better than it’s ever been before.
They may take home a PalmPilot and mark down daily symptoms. They might be blowing into a machine for a respiratory disorder, where we’re following those numbers every single day. So if there’s a problem, we know it.
They also have free access into the center, to come in and be evaluated for any problems they might be having. Right now we are studying–actually, this is really cool. I didn’t mention it before. We’re doing some gastrointestinal diseases.
We’ve built a great partnership with one of the local GI offices in town. So we are currently studying Crohn’s and ulcerative colitis. We’re also studying eosinophilic esophagitis.
Then we have studies for eczema, asthma. And we have studies coming up for chronic sinus disease, more asthma trials, patients with COPD as well.
Yeah, I feel like when people come to us, as a specialist’s office, they’ve tried the basic therapies for their disease.
Let’s use asthma as an example.
They might have an everyday inhaler, a rescue inhaler that they’re using. But now they’re looking for deeper answers to what’s going on.
I think one of the most compelling reasons to participate in research is you can no longer–you can move from being a victim of your disease to actually being part of the solution. Rather than being part of the problem, you’re part of the solution. You’re helping us understand new medications and how they work.
And also, during the course of the study, your health care is free.
You come into the center for any sort of exacerbations. Your medications are generally paid for. And you earn a little bit
of money to participate. That’s not a reason to participate in research trials, but it is a motivation for a lot of people.
We have teenagers who don’t like taking their medicines every day, or forget to take them. In a research study, you
might have a PalmPilot you take home every day. It asks you, did you take your medicine? It might ask you questions about your symptoms. You’d be followed closer than you’ve ever been followed before.
So it really gives us a lot of insight into the day to day, week to week symptoms that a person might be experiencing.
And that also gives the patient some more insight about the disease and the process in their body.