Tag Archive for: randomized clinical trials

What Do CLL Patients Need to Know About Clinical Trials?

What Do CLL Patients Need to Know About Clinical Trials? from Patient Empowerment Network on Vimeo.

What is a clinical trial and how does patient participation work? This animated video provides an overview of clinical trials, the process, and details key steps for engaging in your care.

See More from CLL Clinical Trials 201

Related Resources:

What Are the Types of CLL Clinical Trials?

CLL Clinical Trials: What Are the Phases?

Clinical Trials As a CLL Treatment Option: What You Should Know

Transcript:

 Dr. Singh:  

Hi, I’m Dr. Singh, and this is my patient, Elena, who is living with chronic lymphocytic leukemia, also called “CLL.”

And Elena is participating in a CLL clinical trial.  

Let me start by explaining what a clinical trial IS. Basically, it is a research study with human participants. And the goal of cancer clinical trials is to discover new and improved treatments to treat or to prevent cancer. 

At first, when I asked Elena if she would consider participating, she had a few hesitations.  

Elena:

Yes—even though I trust Dr. Singh, I still had questions. 

So, the first thing I asked was, what steps are taken to protect my safety if I participate in a trial? 

Dr. Singh: 

This is a common concern for many patients, and so I explained to Elena that each trial has a strict safety protocol, with set guidelines to protect patients. Beyond that, researchers are required to follow patient safety rules, which are enforced by the U.S Food & Drug Administration (FDA). At each study location, an institutional review board (or IRB) regularly reviews a study, and many trials are overseen by a group called a data and safety monitoring committee. 

And the trial team, which can include nurses and researchers, closely monitors the health of each trial participant regularly, all throughout the process. This is why clinical trials often require more visits and testing, and, in turn, a bigger commitment from that patient.  

Elena: 

After I felt more comfortable about the safety aspects, I asked Dr. Singh which clinical trial he would recommend for my CLL. 

Dr. Singh: 

That’s right. We discussed Elena’s available trial options, reviewed the pros and cons of each approach, as well as the logistics and potential financial impact. 

And it’s important to note that not every patient will qualify for every trial. Clinical trials have “eligibility requirements,” which can vary widely but may include factors like a patient’s age, health, and any prior treatments they have had.  

Elena: 

And there are several phases of clinical trials, right, Dr. Singh? 

Dr. Singh: 

Yes, exactly. The main phases are Phase I, II, III and IV. Each phase gathers valuable information about the treatment and helps measure its effectiveness.  

Elena: 

So, the main reason I joined a trial was to find out if a newer treatment could be more effective than the standard of care to treat my CLL. AND I wanted to help move cancer research forward for the CLL community. 

Dr. Singh: 

Exactly. Not every patient has the same reason for participation, but trials are essential for developing new and improved treatments for the future. 

Elena:  

I also learned that patients can leave a trial at any time or stage if they wish. 

Dr. Singh: 

That’s a great point, Elena.  

Now that you understand more about trials, how can you find out more? 

  • Start by asking your doctor if there are any trials that are available to you—and, if there is a specific trial that they recommend for you. 
  • If there is a trial that your team recommends, ask to discuss: 
  • The treatment approach used in the study and the purpose of the trial. 
  • The risks and benefits of participation. 
  • The financial costs, if any, and if there are assistance programs to help if you need it. 
  • The location of the trial and whether it can be coordinated with your local institution if it isn’t conveniently located—or, if transportation is available. 
  • How often you will need to go to the trial site and how long the trial will last. 
  • Finally, continue to educate yourself, using resources like clinicaltrials.gov. 

Elena: 

And visit powerfulpatients.org/CLL to learn more about clinical trials and CLL research. 

Dr. Singh: 

Thanks for joining us! 

What Are the Types of CLL Clinical Trials?

What Are the Types of CLL Clinical Trials? from Patient Empowerment Network on Vimeo.

There is not just one type of clinical trial. Expert Dr. Adam Kittai explains the types and how the trials are conducted, including randomized and double-blind studies.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

See More from CLL Clinical Trials 201

Related Resources:

CLL Clinical Trials: What Are the Phases?

 
Why Should CLL Patients Consider Participating in a Clinical Trial?

A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Okay. You mentioned randomized clinical trials. There are a couple of other clinical trials as well. Would you define them and tell us how they’re different from one another?  

Dr. Kittai:

Yeah. So, a randomized trial is when you enroll onto a study, and you get randomly assigned to either the experimental arm or the control arm. The experimental arm is that new drug that we talked about. And the control arm is usually the standard of care. So, that’s a randomized study. 

And randomized studies are usually Phase III trials, but they can be phase two in some scenarios as well. You have – usually that’s paired with a randomized control study. So, a control study is just there’s a control arm, that’s what that means. But those usually go hand in hand. Those are usually together.  

And then another trial is the double-blind clinical trial. So, a double-blind clinical trial means that once you’re randomized to either the experimental or the control, neither you nor the physician know what drug you’re taking. And that usually is not used in CLL trials. Usually, we know what drug the patient is assigned to. And the reason why that is, is because oftentimes we’re looking out for specific adverse events or toxicities of the drugs we’re implementing at Phase III.  

And then, also, if you’re getting a triplet versus a doublet, meaning three drugs versus two drugs, it’s very hard to blind somebody to know which drug they’re on because obviously you’re getting three drugs versus two drugs. Or if an infusion is involved in one arm but not in the other arm, you obviously know that you’re getting an infusion versus an oral drug. 

Katherine:

Ah, okay. Are there common clinical trial terms that you think patients should know about? 

Dr. Kittai:

I think we covered most of them. So, knowing that phase one is typically the first in the sequence of events that I would ask your physician if this was a first in human study, right, because that comes with some special considerations knowing that you are the first human to receive a new drug is very important. Versus a phase three study where, you know, you know this drug has already gone through phase one and two in development, meaning it’s been given to a lot of patients, and they’re just looking to see if it’s better than standard of care. So, I think knowing those general concepts about what’s the difference between a phase one and a Phase III study, it’s very different. I think it’s important to keep those in mind when talking about clinical trials and discussing with your doctor.