Tag Archive for: phase I

What Do MPN Patients Need to Know About Clinical Trials?

What Do MPN 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 MPN Clinical Trials 201

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Understanding Common MPN Clinical Trial Terms

Understanding Common MPN Clinical Trial Terms

Understanding Clinical Trial Phases

Understanding Clinical Trial Phases

MPN Clinical Trials: Updates on MPN Treatment and Research

Clinical Trials As an MPN Treatment Option: What You Should Know


Transcript:

Brian: 

Hi, I’m Brian and this is my doctor, Dr. Liu. 

I have myelofibrosis, which is a type of myeloproliferative neoplasm, or MPN as it’s commonly referred to. 

And when discussing therapy with my doctor. She suggested a clinical trial might be my best treatment option. Dr. Liu, can you please explain what a clinical trial is? 

Dr. Liu: 

Absolutely. In basic terms, a clinical trial is a research study that involves human volunteers. The goal of cancer clinical trials is to discover new and improved approaches to prevent or treat the disease.  

There are typically four phases of a trial. Each phase gathers valuable information about the treatment and helps measure its effectiveness1 

But, Brian you had some hesitations at first, right? 

Brian:  

That’s right.  Although I trusted your advice, I definitely had questions about the process.  

One thing I worried about was safety. I asked Dr. Liu how I would be kept safe if I participated in a clinical trial. 

Dr. Liu: 

I hear this concern a lot from patients. But every trial has a strict safety protocol, with set guidelines in place to protect patients.  

Additionally, researchers must follow patient safety rules, which are regulated by the U.S Food & Drug Administration (the FDA). And an institutional review board (or IRB) regularly reviews a study at each study location. Plus, many trials are overseen by a group called a data and safety monitoring committee2. 

Finally, there is also a clinical trial team that can include healthcare team members like cancer researchers and oncology nurses. This team regularly observes the health of each participant, through each stage of the process. Because of this, trials often involve more testing and visits, which can be a bigger commitment for a patient. 

Brian: 

When Dr. Liu explained the safety measures, it helped me feel more confident in the process and comfortable about participating. So, then I asked which trial she would recommend for my individual disease.  

Dr. Liu: 

It’s important to note that every trial has “eligibility requirements” that include things like a patient’s age, health, and prior treatments they have received. These requirements determine whether a patient qualifies for a trial. 

We talked about which trials may be a good fit for Brian and discussed the pros and cons of each one. We also reviewed the logistical and financial impact the trials could have on his life.

Brian: 

That’s right. Dr. Liu also pointed out that patients can leave a trial at any time–for any reason– once they have enrolled.

Dr. Liu: 

That’s right—participation is completely voluntary. 

Brian: 

One of the main reasons that I joined a trial was because I wanted to find out if a treatment in development would be more effective in treating my cancer. AND I wanted to help advance research forward, so I could help the MPN community.  

Dr. Liu: 

Right, Brian. Patients may have different reasons for participating, but trials are the only way to develop and study new and improved treatments for MPNs. 

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

  • Start by asking your doctor if there are any trials that you are eligible for.  
  • 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. 
  • And, how often you will need to visit the trial site and how long the trial will last. 
  • Finally, continue to educate yourself, using resources like clinicaltrials.gov. 

Brian: 

We hope you found this information useful! Visit powerfulpatients.org/MPN to learn more about clinical trials and MPN research. 

Dr. Liu: 

Thanks for joining us! 

What Happens in Each Phase of a CLL Clinical Trial?

What Happens in Each Phase of a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

What are the phases of clinical trials? CLL expert Dr. Michael Choi outlines the research purpose of clinical trials and what happens in each phase.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. More information on Dr. Choi here. 

See More from CLL Clinical Trials 201

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CLL Clinical Trials: What Are the Phases?

 
How Are CLL Patients Monitored After a Clinical Trial Concludes

How Is a Patient’s Safety Monitored in a CLL Clinical Trial

Transcript:

Laura Beth:

Dr. Choi, can you please walk us through the phases of a clinical trial and what happens during each phase?  

Dr. Choi:

That’s a great question. Yeah, historically, trials have been divided into different phases. The way I think of it is when a drug is first being tested, we don’t want to expose too many people to it, because we’re still learning about the right dose and about its safety. And then, as we learn more and more and maybe get some confirmation that it’s doing what it’s supposed to do, then we have bigger trials and eventually, bring in some comparisons to existing standards.  

So, a Phase I trial is usually, I would say, a few dozen patients, getting the drug for the very first time or sometimes for the first time for this diagnosis. Oftentimes, the very first Phase I trials might have a dose escalation component where the first dose or the first group of patients might get a dose that is based on an assurance that it will be – or some confidence that it will be safe and well-tolerated.  

Then, as the trial goes on, a higher dose will be used once we see that the previous doses are safe. Now, sometimes, this dose escalation happens in between different groups of patients, and sometimes, some trials will escalate the dose for even within an individual patient. But the basic idea of it is to start at doses that we think will be safe and then to gradually escalate it, again, prioritizing the safety of the patients.  

I shouldn’t also – although Phase I trials are designed to determine the safety of a drug, there are many Phase I trials that show clinical activity and benefit to the patients, so I don’t think people should be altogether discouraged from enrolling in a Phase I trial either. 

I can also say that some Phase I trials are just looking at a combination of drugs that we have experience with already, but designed or written as a Phase I trial, because we have to confirm the safety of those two drugs. In those trials, the doses might not be that different than what’s used already, and there’s often more expectation of immediate clinical benefit. Phase II trials are where we’re principally looking or usually looking mainly at the response rate or some sort of clinical endpoint, how many patients get into a partial remission, or how many patients get into a complete remission and so on.  

And I would say these are usually our trials that are 20, 30, 50 patients, to that effect. And basically, from that group of patients, we can get a pretty good estimate of how effective a drug or a drug combination may be. And then finally, the third type of trial, Phase III trial, is when a new drug or a new combination is compared directly to a different – to what would be considered the standard of care at the time.  

So, this is a way that we can get more confidence that this new drug is indeed better than what we’ve been doing up until now.  

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

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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! 

Understanding Common Clinical Trial Terminology

Medical terminology can be confusing and is especially important to understand when reviewing information to learn about a clinical trial. Dr. Pauline Funchain of Cleveland Clinic explains common terms and phrases to help patients better understand the clinical trial process.
 
Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Katherine Banwell:

Dr. Funchain, are there common clinical trial terms that patients should know? 

Dr. Pauline Funchain:

Yeah, there are trial terms that people hear all the time, and probably should know a little bit about. But I think the most common thing people will hear with trials are the type of trial it is, so Phase I, Phase II, Phase III. The important things to know about that are essentially, Phase I is it’s a brand-new drug, and all we’re trying to do is look for toxicity. Although we’ll always on the side be looking for efficacy for whether that drug actually works, we’re really looking to see if the drug is safe. 

A Phase II trial is a trial where we’re starting to look at efficacy to some degree, and we are still looking at toxicity. And then in Phase III is, we totally understand the toxicity, and we are seeing promise, and what we really want to do is see if this should become a new standard. So, that would be the Phase I, II, and III. 

Another couple of terms that people hear a lot about are eligibility criteria, or inclusion criteria. So, those are usually some set of 10 to 30 things that people can and can’t be. So, usually trials only allow certain types of cancer, and so that would be an inclusion criteria, but it will exclude other types of cancers. Most trials, unfortunately, exclude pregnant women. That would be an exclusion criteria.  

So, these are things that, at the very beginning of a trial, will allow someone to enter, or say, “You’re not in the safe category, we should not put you on a trial.” Many trials are randomized, so people will hear this a lot. Randomization.  

So, a lot of times, there is already a standard of care. When there’s already a standard of care, and you want to see if this drug is at least the same or better, then on that trial, there will be two different arms; a standard of care arm and experimental arm.  

And then in order to be fair, a randomized trial is a flip of a coin. Based on a electronic flip of a coin – nobody gets to choose; not the doc, not the patient. On that type of trial, you’ll either get what you would normally get, standard of care, or something new. So, that’s a randomized trial. Not all trials are randomized, but some are. And those are the things that people will run into often. 

Are CLL Clinical Trials Safe?

Are CLL Clinical Trials Safe? from Patient Empowerment Network on Vimeo.

What should CLL patients know about clinical trial safety? CLL expert Dr. Adam Kittai explains concerns that patients should discuss with their doctor, the level of research before Phase I studies, and drug safety monitoring.

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

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Transcript:

Katherine:

Patients often have questions about safety. What are the risks of clinical trial participation?  

Dr. Kittai:

Yeah, so before anybody enrolls onto a clinical trial, you should sit with your doctor to talk about the pros and cons of entering this clinical trial. One of the things that they will talk to you about is what the expected safety of this drug is. So, you might ask yourself, well, if it’s a phase one study, first in human study, how do they know what toxicity to expect? 

Katherine:

Right. 

Dr. Kittai:

The answer is that there’s a lot of pre-human studies that occur, both in mice and monkeys and other animals, and researchers often have a good idea of what to expect in human. But there is a lot of unknowns in a phase one clinical trial. And after discussing with your doctor the pros and cons of going on a clinical trial and what side effect profile to expect from whatever drug or combination that you are about to be using, usually you go through a consent.  

Usually, you’ll get a packet, it’s about 10 to 20 pages long, written in a way that patients can understand. And it’ll have a list of toxicities that are associated with the research that is occurring. In terms of knowing what adverse events might happen, the consent is key, because it’ll have those all listed out.  

And also having the conversation with your physician about either what they’ve experienced giving this clinical trial, or what is to be expected after this drug had been introduced pre-humans.  

Katherine:

Mm-hmm. Are there protocols in place to protect patients? 

Dr. Kittai:

Yes. So, remember how we talked about in the phase one trials, we dose escalate the drug until we’ve reached some toxicity limit? There are specifically rules written out in a protocol that the doctor must follow that ensures safety for the patients that enroll in clinical trials. And that dose escalation part where we reach a toxic limit is a key part of those phase one trials that is spelled out before you even enroll.  

Usually, there’s also something called a Data Safety Monitoring Committee, as well as other committees that are looking at patients as they are receiving these drugs and move forward on clinical trials to make sure that the investigators are following the protocol as printed. That if anything happens, they document why it happened and fix the problem before it becomes another problem for a patient. So, there are very specific safety rules and a lot of redundancy to protect our patients, because the number one priority is to protect the patient. 

Katherine:

Yeah. I think you’ve already answered this, Dr. Kittai, but how do you know the medicine is safe before a human trial even begins? 

Dr. Kittai:

The answer is you don’t. There is some risk. As I said, they do test it in animals before they give the drug to humans, and they usually start at the lowest dose possible. But there are certain circumstances where there are surprising side effects that are not expected. And so, when you’re entering a first in human, Phase I trial, that is a specific risk that you do need discussed with your physician about before you enroll. 

Katherine:

Can a patient change their mind once they’ve enrolled in a clinical trial? 

Dr. Kittai:

Always. Always.  

Katherine:

Okay. 

Dr. Kittai:

They can come off the clinical trial at any point if they choose to. 

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

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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.  

CLL Clinical Trials: What Are the Phases?

CLL Clinical Trials: What Are the Phases? from Patient Empowerment Network on Vimeo.

CLL clinical trials have different phases, but what happens in each phase? CLL expert Dr. Adam Kittai explains the goal of each phase in relation to research and patient care.

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:

What Is a Clinical Trial and What Are the Phases? 

Why Should CLL Patients Consider Participating in a Clinical Trial?

A CLL Expert Addresses Common Clinical Trial Misconceptions

Transcript:

Katherine:

Let’s talk a bit about how trials work, starting with the phases. What happens at each phase?  

Dr. Kittai:

There are actually four phases of clinical trials, although three phases are typically what’s talked about. So, Phase I is when we are first introducing the new medication, the combination, or the old medication in a new scenario for the first time in a human being.  

Phase one encompasses a lot of different things. It could be a first in-human phase one, where we’re giving the drug for the first time in a human being. It could be, as I said, the combination of drugs being used for the first time in a human being. Or it could be that we have this drug that works for this other cancer and we’re trying it out on this new cancer. So, we might have experience with this drug in another scenario, but not in the scenario we’re trying to do.  

And the primary purpose of the phase one clinical trial is to see if it’s safe. So, that’s the primary purpose of a phase one clinical trial – see if this new medication, this old medication in this new scenario, or this new combination is safe to use going forward.  

Katherine:

Right. 

Dr. Kittai:

We are able to see if it works to a small degree in the phase one trial, but typically these trials are very small with somewhere between 10 to 50 patients. And so, it’s hard to know how well this works by looking at such a small amount of patients.  

Once the Phase I trial goes forward, we usually go onto Phase II. So, one of the other points about Phase I is to determine the correct dose. Usually in phase ones, we increase the dose of the drug slowly until it meets some sort of toxicity cut-off for our patients. So, once that dose is discovered, then we move onto Phase II, and Phase II is usually a small study, usually about 50-100 patients where we’re looking at preliminary efficacy, to see if this drug, this new combination, or the drug in a new scenario, is actually working.   

And so, Phase II will tell us we think it’s working and if it looks good in phase two, it gets moved onto Phase III. Phase III is the final part of the drug development, where if it passes Phase III, it usually gets approved by the Federal Drug Administration. And Phase III is usually a randomized trial where you’re giving the new drug, the combo, or the old drug in a new situation, and you’re comparing it to whatever’s used as standard of care in that particular scenario.  

Katherine:

Right. 

Dr. Kittai:

And that’s usually a randomized study where patients are either getting the new thing or the old thing. And then, we’re determining which one works better. Lastly is Phase IV, and this is post marketing. So, after a drug gets approved, the drug company and the FDA requires just a wide scope of just data that’s collected to see how well the drug is working and if it’s safe once it’s brought out to the wider community.  

Why Should Metastatic Breast Cancer Patients Consider a Clinical Trial?

Why Should Metastatic Breast Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo.

Why should metastatic breast cancer patients consider participating in a clinical trial? Dr. Jane Lowe Meisel discusses when clinical trials may be considered, explains the stages of trials, and shares a valuable resource for patients.

Jane Lowe Meisel, MD is an Associate Professor of Hematology and Medical Oncology at Winship Cancer Institute at Emory University. Learn more about Dr. Meisel here.

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Transcript:

Katherine:

So, you mentioned earlier, clinical trials. When should patients consider participating in a trial?

Dr. Meisel:

I think it’s a great question and I think the answer is really, almost any time. There are trials in every setting. So, I think one of the common misconceptions about clinical trials is that you really only should be in a clinical trial, or your doctor might only mention a clinical trial if they don’t have other options for you or if you’re really in stage. And I think that perception is changing. But I think the reality is that there are clinical trials in every setting.

So, we have clinical trails looking at prevention of breast cancer. Clinical trials looking to optimize early-stage treatment of breast cancer. Clinical trials looking at secondary prevention, so once you’ve had breast cancer, how can we reduce your risk of recurrence. And then lots of clinical trials in the metastatic setting both for patients who are initially diagnosed with metastatic breast cancer.

And then in second, third, fourth line and even for patients who have had tons and tons of additional therapy that we’re looking at new drugs for. So, I think at almost any juncture where you’re making a treatment change, it’s probably appropriate to say, would there be a clinical trail that you can think of that would be good for me in this setting? And it may be that there’s a one that’s 12 hours away, and it’s not convenient for you or feasible.

And maybe that your doctor doesn’t necessarily know of one but then that prompts them to ask a colleague who may be more involved in clinical trial design and development. Or it may be that there is one, but you ultimately choose not to pursue it because you have a different option. But I think it’s always appropriate to ask, would there be a trail for me? Because if there is, then maybe that opens up an option you hadn’t thought about before.

Katherine:

Sure. For patients who aren’t familiar with the stages of clinical trials, would you give us a brief overview of the stages?

Dr. Meisel:

Yeah. Absolutely. So, in terms of clinical trials that’re being done in humans, we talk about Phase I, Phase II, and Phase III typically. So, a Phase II clinical trial is typically an earlier stage trial.

Looking at either a drug that has not been tested in humans before or a drug that has not been tested in a particular combination in humans before. And so, those trials are done only in select institutions, usually academic institutions as opposed to private hospitals. And they often have what’s called a dose finding phase and then a dose escalation phase. So, the earliest part of those trials is actually looking at, what is the safest dose to give to patients?

So, they start the first patients at a low dose of the compound. And if those patients do well, the next patients that’re enrolled get enrolled at a slightly higher dose. And then up until they reach the highest dose they can find where people are tolerating it and doing reasonably well. And in those Phase I trials, doctors and investigators are also evaluating efficacy, is this drug working. But the primary goal of the early phase trial is actually to find the right dose to then study in larger groups. And so, if they find the right dose and there’s good biological rationale for the compound, then the trial would go on to a Phase II.

Which might be just what we call single arm Phase II study, where every patient is getting that experimental drug. And we monitor them to see, is the drug effective or is it less effective than the standard of care? Or sometimes they’re what we call, randomized Phase II trials where patients are randomized to either get the experimental drug, or to get what the standard of care would be in that situation. I think a lot of people get afraid about the idea of a randomized trial because they’re afraid they’re going to be randomized to a placebo. And that is really not done in the metastatic setting because it wouldn’t be ethical to give a patient with active cancer a placebo.

So, usually the randomization would be either to the study compound or to a standard of care drug. And then if things look good in a Phase II trial, then a Phase III study is done which is usually what the FDA requires to allow a drug to go on and be administered outside of a study for approval. And those Phase III trials tend to be larger studies that’re done in larger groups of patients with more statistical validity because of their size, to determine, is this drug really better than the standard. 

Trustworthy Resources to Help You Learn More About Lung Cancer

Trustworthy Resources to Help You Learn More About Lung Cancer from Patient Empowerment Network on Vimeo.

Expert Dr. Martin Edelman shares credible resources to help lung cancer patients become informed and empowered.

Dr. Martin J. Edelman is Chair of the Department of Hematology/Oncology and Deputy Director for Clinical Research at Fox Chase Cancer Center. More about this expert here.

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Transcript:

Patricia:

Let’s talk a little bit about health literacy. What would you suggest patients use for online resources? What are good resources?

Dr. Edelman:

So, there are some excellent resources. The International Association for the Study of Lung Cancer has resources for patients. The National Coalition of Comprehensive Cancer Center Network (NCCN) has resources. American Society of Clinical Oncology has resources. So, those or American Cancer Society. So, there are some really reliable sources out there. And there’s a great deal that’s very unreliable – people’s Facebook pages. I’ve seen this.

Patricia:

It’s a big place.

Dr. Edelman:

Everybody always – and I think it’s important for people to understand. There will be people who will get something and have a fantastic response. I’ve used anecdotes.

The anecdotes I’ve used are to illustrate the potential hope of benefit. They’re not exceptions to the rule anymore. They’re the good case scenarios. I could have just as many anecdotes of people who didn’t benefit and stuff. And I think it is important going into this – and that’s why we are reassessing patients constantly and getting repeat scans because we don’t necessarily know always – even if something’s 90 percent effective, it means 10 percent of the time it’s not.

And each patient – we’re getting better at individualizing and personalizing therapy, but we’re not perfect yet. And we probably never will be. So, there will always be anecdotes. I think what’s – as a friend of mine puts it – the plural of anecdotes is not data. When I say, “Well, chemoimmunotherapy works.” It’s not because I have anecdotes of that, though anecdotes illustrate the magnitude of benefit.

I have data that shows that the chemoimmunotherapy regimen was compared to chemotherapy and was clearly and unequivocally superior. When I give a statistic that 60 percent of patients, 65 percent, can benefit from those types of regimens. That’s based upon prospective randomized control trials.