When it comes to childhood cancer and many other life-threatening conditions, research has been at the forefront of bringing more effective treatments and better patient outcomes.
Cure 4 The Kids Foundation is dedicated to participating in clinical research if it is in the best interest of the patient, and if it helps patients in the future.
With that in mind, we spoke with Cure 4 The Kids Foundation’s Chief Medical Officer, Dr. Alan Ikeda about some research basics:
C4TK: Is there a difference between a clinical trial and a protocol?
Dr. Alan: The purpose of the clinical trial may be to determine the safety, efficacy, or a comparison of particular medications or treatment regimens.
A protocol relates to the instructions on how to run a clinical trial. If the clinical trial is completed, then the protocol may still be utilized as a guideline to treat patients who have the target disease. For example, the protocol would dictate when you do a check-up on the patient involved in the clinical trial, or when you check their labs, when to give what chemotherapy, etc.
C4TK: There are different phases of clinical trials, can you help explain?
Dr. Alan: A phase 1 clinical trial determines the safety of a treatment or medication. Before a drug gets to a phase 1 clinical trial, it has passed a level of testing to determine that it should progress to the phase 1 stage. These are often first in human testing of a drug. Previous testing can include testing at the molecular or cellular level and even with human tissue models — or a combination of all. According to the FDA, a phase 1 clinical trials are usually limited to 20 to 100 participants.
If the phase 1 trial is deemed successful, it moves onto phase 2. A phase 2 trial involves a larger group of people — up to several hundred — and the study can be up to two years in length. What researchers continue to focus on is whether the medication is safe and whether it is having an effect on the patient’s condition. There are often Phase I/II trials that combine testing the safety and efficacy. This format has been beneficial to advance the progress of medicine to get new medications on a quicker track to the bedside.
If successful in phase 2, the clinical trial moves onto phase 3. The vast majority of interventional clinical trial participation by oncology patients at Cure 4 The Kids Foundation are in phase 3 trials. In phase 3, there can be as many as 3,000 patients in the study and it may continue for years. Researchers are continuing to monitor the effectiveness of the medication and check for any adverse reactions.
C4TK: Do you always recommend a patient participate in a clinical trial if they are eligible?
Dr. Alan: It certainly depends on the study as to whether I would recommend a patient to participate. We do evaluate the scientific value of each study before we ever decide to open a trial at Cure 4 The Kids Foundation. There must be some reasonably attainable and meaningful research goals for us to participate. We also want to be certain we will be able to collect data and have an outcome that we can measure — otherwise, there is no sense in participating. If it meets those goals, we will encourage patients to take part.
One reason we can treat and cure so many patients is due to clinical trials of the past. If you look back to just before I was born in the 1960s and 70s, the chances for a cure in children’s cancer were very poor — much less than 10 percent. Now we have an overall cancer cure rate of about 85 percent for all Pediatric Oncology patients. That is a direct result of clinical trials.
C4TK: These clinical studies often originate out of large teaching hospitals in large metropolitan centers. Will Cure 4 The Kids Foundation ever develop a clinical trial of its own?
Dr. Alan: Part of our mission and vision at Cure 4 The Kids Foundation is to advance medical technology. We plan to continue participating in clinical trials but also would like to develop new things here.
We have a collaborative venture with Roseman University of Health Sciences. I would like to build our program so that we can have academicians, including bench and translational researchers join our program. We look forward to having some collaborative efforts with Roseman and have new, cutting edge, and innovative studies here in Las Vegas.
C4TK: Can you define bench research?
Dr. Alan: Bench research looks a lot like what people may see on television, including working with beakers and flasks in a laboratory. Often, it will include working with genes, molecular pathways, or cellular level testing and looking at things farther away from the human being. These are things that are typically done on the lab bench and thus the term: bench research. It may also be referred to as basic research or wet lab.
You can find additional information about the clinical studies Cure 4 The Kids Foundation patients are currently involved with by going to cure4thekids.org/research page