Jai Patel, PharmD, chief of pharmacology research for Phase 1 trials at Atrium Health’s Levine Cancer Institute (LCI), spends his days overseeing clinical trial patients and monitoring how they respond to the latest cancer drugs. Keep reading to learn his answers to the most frequently asked questions about cancer clinical trials.
So, what exactly is a clinical trial?
New treatments aren’t offered to the public as soon as they’re made. First, they need to be studied.
A clinical trial is a defined way to study a new medication that hasn’t been approved yet for a specific use, such as treating a certain type of cancer. Clinical trial participants have the opportunity to receive new treatments before they’re widely available. Since we’re testing non-approved medications, it’s all done in a highly regulated setting.
What are the potential benefits of joining a clinical trial?
The potential benefits of each trial are different, but in general, clinical trials give patients access to the most innovative cancer treatments available. At LCI, each study is conducted by our highly skilled team of experts who are leaders in the field of cancer research. And over time, clinical trials help us learn more about cancer, improve care for future patients and make progress in the fight against cancer.
What are the 'phases' of clinical trials?
The different phases – Phase 1, Phase 2 and so on – refer to what exactly we’re testing and how far along we are in that process. Here’s a breakdown of each phase:
- In Phase 1 trials, we’re testing medicines that aren’t approved yet for a given use and are often being given to a patient for the first time. The goal here is to look at the drug’s side effects and how people are tolerating it, and to figure out the best dosage.
- In Phase 2 trials, we start with that “best dosage” and then look at its clinical effectiveness against the cancer in a larger population.
- In Phase 3 trials, we start to test the new drug against the current standard of care drug to prove that it works better.
- In Phase 4, we’re testing the long-term effectiveness of the drug over an extended period of time in a significantly larger number of people.
Are they safe?
Patient safety is a top priority. Because we’re testing drugs in real people, there’s a lot of research that happens long before patients ever take a drug. We must have very good pre-clinical (before human) data to show the drug is safe and effective before starting a trial. There’s a very high standard of safety that must be met.
We’re honest with patients about what the risks are and what we expect them to encounter in terms of side effects. During Phase 1, we often start patients at a very low dose and slowly increase it in a controlled fashion to determine the most appropriate dose that doesn’t cause too many side effects. But often, patients are willing to accept the possibility of side effects because other treatments haven’t helped them, or because there are no other treatments available.
If a patient enrolled in a trial no longer wants to participate, they can withdraw from the study at any point for any reason.
Are they really expensive?
Overall, clinical trials give patients access to groundbreaking therapies at little to no cost. It depends on the trial design, but because most of the drugs aren’t approved yet, drug companies usually cover the costs of the trial. Sometimes patients can even be monetarily compensated for participating in trials.
If there’s anything within the trial that’s considered routine – things that would have been done as part of the patient’s standard of care – that may end up being billed to insurance. If you need help with your insurance, we offer financial counseling as part of our comprehensive cancer support program.
How accessible are they?
Traditionally, clinical trials have mostly been offered at large academic centers. That means that a lot of the time, patients have to travel to participate, which is an unfortunate and unnecessary hassle.
At LCI, we think patients should have the same access to trials no matter where they live. We offer clinical trials to many of our locations across the Carolinas, so patients don’t have to travel far to get the latest treatments. And now, we’re one of the few centers offering Phase 1 trials at multiple locations.
How hard is it to get into a trial?
In general, you have to meet certain guidelines (criteria) in terms of your age, type of cancer, lab values and organ function. Normally, the criteria are set by the drug maker. The criteria are different for every trial and some are harder to get into than others.
A lot of people think you have to be out of treatment options and close to dying to join a clinical trial. That’s not true! There are many trials being offered for all stages of common and rare cancers, including recurring or advanced cases. There are even clinical trials that address other symptoms that cancer patients experience, such as pain, fatigue and loss of appetite.
There are a lot of clinical trials out there, and if you have cancer, there’s a good chance there’s a trial that you’re eligible for. And at LCI, we bring you more clinical trials than any other cancer center in the region. Talk to your doctor to find out what clinical trials may be available to you. You can also explore Levine Cancer Institute’s current clinical trials here .
Levine Cancer Institute brings you world-class cancer care, close to home. Find out more about our innovative cancer treatments, leading experts and comprehensive support at AtriumHealth.org/LevineCancer .
