By: Jillian Ramos
TAMPA, Fla. — As talks of a vaccine and treatment for COVID-19 continue, we reached out to ForCare Medical Group to find out more about how clinical trials work and the length of time they normally take.
Dr. Seth Forman and his team are on the front lines of clinical research. Right now, they are doing research on a variety of autoimmune diseases.
He calls people participating in these clinical trials heroes.
“Because they’re not only hopefully making themselves better, but also a representation of thousands, maybe millions of people who will be treated by medication that they were heroic enough to better themselves,” explains Dr. Forman.
The case would be no different if his facility would be allowed to test for vaccines or drugs to use against COVID-19.
“We have informed our partners in research, some of these companies we work with very closely, and let me know that we are ready and willing to pivot and commit our resources to conducting our clinical trials to COVID-19, whether it be the vaccine or therapies,” says Dr. Forman.
But how do these clinical trials work?
Dr. Forman says they start very early on in animals, like monkeys, orangutans, dogs, etc. Then, they do something called “FIH testing,” that’s first in humans.
These people are usually healthy and often times don’t even have the disease they are testing the drug to work for.
“They test in a very low number of people probably low 10s, maybe 20-30 people,” said Dr. Forman. “And then once they have confirmed safety they will do an extended phase one trial.”
That is when they try it with people with the disease using a very limited number of people.
“They need to make sure it’s not causing a change in the disease or having the disease in question have a deleterious effect of having the medication, as well,” explains Dr. Forman.
Phase 2 is dose ranging trials.
“Meaning you’ll try a drug for a variety of doses to try and find a dose that may work for the disease in question and ensure or try to ensure, it’s safe,” says Dr. Forman.
Phase 3: Multiple pharmaceutical companies are exploring trials that may upregulate the process that will provide therapies and vaccines to humans at this time.
Dr. Forman says the rule of thumb is that from the first human trial to getting FDA approval and getting a doctor to write you a prescription can be anywhere from 7 to 10 years.
In the midst of a pandemic though, he says some rules could change to speed up the process.
“However, and as we’re speaking right now, there could be some type of government change in policy which may up-regulate the process especially with this type of condition that we’re dealing with right now,” explains Dr. Forman.
Another shocking statistic. Only between 1 in 10 and 1 in 20 medications ever make it from phase 1 to market.
Dr. Forman says Botox is a perfect example why.
Botox was brought to market many years ago. It had passed phase 3 trials and it had gotten approval from the FDA to be treated for a condition called blepharospasm.
Ophthalmologists were using this medication and treating patients with this medication when they noticed these patients were having less wrinkles around their eyes and foreheads. That is when the makers of Botox went back to Phase 3, skipping phase 1 and 2, and tested the medication for cosmetic purposes.
“Most of the revenue from Botox today is for cosmetic purposes because of this happy little mistake,” explains Dr. Forman.
Which could be good news as we look for ways to treat COVID-19.
“There are a number of medications that are currently at market for other conditions for which we have no data, no phase 3 data for COVID-19,” says Dr. Forman.
“I’m in no way a proponent right now of trying anything that we are not certain or at least relatively certain of the safety,” says Dr. Forman. “I could see, almost like the Botox story, some of the early phases of research and skip to the area where we don’t have to confirm the safety in a healthy human and find a dose ranging study, if we can skip some of the phases appropriately and safely and test it.”
Dr. Forman says testing is so important because these medications could also have side-effects for people with COVID-19 that we don’t know about yet. And those factors need to be monitored.
You can read more about ForCare Clinical research by clicking here.