Cancer Clinical Trials: The Search for a Cancer Cure

Finding the cure for cancer depends on clinical research. Many patients aren't even aware that they can participate in clinical trials or research studies. Watch this video for an overview of cancer clinical trials and to learn how you might be able to participate in one.  This is not intended as medical advice. Please talk to your doctor before beginning any new health practice.

Transcript:

Hello everyone.  I’m Dr. Lisa Schwartz and this is Cancer Straight Talk where you get cancer information from a cancer doctor.  Today we are going to be discussing how we get closer to a cure for cancer.  How did we as medical professionals come to know that the treatment that is being recommended to you is the best that we have to offer right now? How is it that we discover and evaluate new treatments for cancer?  Well that is what clinical trials are all about.

Before a treatment or procedure becomes the next greatest advance in cancer care, it must prove that it’s better than what we’ve already got.  To get to that point, the new treatment or procedure must go through several steps.  The first steps you don’t involve patients at all but instead testing is done on cell cultures and animals.  We use the term “clinical” trials to designate those trials that involve humans as the test subjects. 

The new treatments go through phases each with a specific purpose.  A phase I trial is the first time a drug has been given to a human.  This means there’s a lot we don’t know about it.  The goals of these trials include finding the appropriate dose and seeing how the drug affects the human body.  How is it metabolized and what side effects does it cause?  Usually a small number of patients is involved in a phase I study.

A phase II study is the first time we look at whether or not a new treatment actually is effective at treating a specific cancer.  Does it work for this cancer?  Side effects are still followed closely and there are up to 100 patients involved in these studies.  Still very small but bigger than phase I trials.

A phase III study is where a new treatment “makes it or breaks it.”  Here the new treatment is tested against the standard treatment for that cancer and may involve hundreds to thousands of patients.  These are the studies that get the most attention and can be the most exciting for doctors and patients.  In general, after these studies, the successful drugs will go for FDA approval.  If a new treatment was successful, it will become the new “standard of care.”

Phase IV studies are done to see how the new treatment is performing in the “real world” and long term.  Sometimes side effects haven’t shown up until the new treatment is tested in thousands more patients at varying levels of health and taking a variety of other drugs. 

Clinical trials are very controlled.  And that’s putting it mildly. They are very controlled. The investigators try to account for all the variability among patients and their cancers so that they can answer the very specific question of whether or not the new treatment is better than existing treatment, and be sure that the answer depends solely on the treatment and not other factors.  Strict guidelines called a protocol are followed.  Your doctor and perhaps a research nurse will determine if you meet the entry criteria for a particular trial.  For example, most trials specify a tumor type, stage, and whether or not prior treatment has been given in order to be considered for the trial.  If you are eligible then generally you will be assigned a treatment at random.  This is important:  you do not get to choose whether or not you receive standard care or the experimental new treatment.  This is determined by a process called randomization. Often you and your doctor do not know which treatment you are receiving.  This is called blinding.  Both randomization and blinding help to prevent statistical bias which is including nonrandomized factors into the treatment which may influence the outcome and have nothing to do with the treatment itself.  So bias may give you a result that is not the true result, and then the trial results are not valid and can’t be used to make any recommendations or changes in treatment.

Some patients who are considering a cancer clinical trial may be concerned that they are going to get a placebo or sugar pill.  Placebos alone are almost never used in evaluating new cancer treatments.  It is almost always the existing standard of care treatment versus the new treatment.  Sometimes a placebo may be added to the standard treatment to make it indistinguishable from the experimental treatment.  In this case you will be told if a placebo is being used in one of the treatment arms (or options).  For example, let’s say that there is a standard treatment of intravenous chemotherapy for a certain cancer.  There is a new experimental drug that is an oral pill and we want to see if it adds anything to the standard chemotherapy.  So the two treatment arms would be standard chemotherapy plus a placebo pill or standard chemotherapy plus the new experimental pill.  In this case the arm with the placebo is still getting the standard chemotherapy but they are also taking an oral pill so that they don’t know which treatment arm they are on—remember blinding that we discussed earlier.

How can you be sure that you will be protected while on a clinical trial?  It is experimental treatment.  Well, there are very strict standards and frequent reviews to make sure that patients are being treated appropriately and safely.  Any side effects that are significant or unexpected may cause the trial to be stopped. 

Clinical trials do take up more of your time and more of your doctor’s time.  But without them, we would not make progress on cancer treatment.  As part of your informed consent, your doctor or research nurse should explain what the standard care is and what the experimental care is.  Any potential side effects that are already known will be discussed in detail.  Being treated according to a protocol may require extra blood tests or scans.  All of these extras should be covered financially when you are on a trial.  You should have the same financial responsibilities as if you were not on a trial.  This is a question, however, that you should ask when you are being asked if you want to participate in a trial.

On your follow-up visits you will likely have to answer more questions than just, “How are you doing?”  But on the flip side, this means that you are being very closely monitored.

So being treated on a clinical trial can be very exciting since you may get a treatment that is better than the standard…it may also not be as good as the standard.  We have no way of knowing without doing the trial.  In this way, patients who participate in clinical trials are advancing our medical knowledge and serving the patients who come after them in the same way that patients who came before helped to define our current treatments.  So if you are interested, ask your doc if there are any trials for which you may qualify.

I hope you have found this overview of clinical trials helpful.  Please let me know if you have any questions or comments by leaving them below.  If you know someone else who might benefit from this information, then please feel free to share it.  Click the “like” button below if you got anything out of this.  And for more information on cancer and its treatment, please visit CancerStraightTalk.com.  Until next time, take care and be well.