Clinical research is a critical component in expanding treatment options for people with all types of cancer. All new cancer therapies in the last 50 years have come by way of doing research. Comprehensive Cancer Centers of Nevada has built an extensive clinical research program offering groundbreaking treatments to patients in Southern Nevada and from out-of-state. We participate in 170 Phase I, Phase II and Phase III clinical trials each year, and through our research efforts, we have helped develop more than 60 FDA approved cancer therapies.
The physicians at CCCN are dedicated to developing clinical research that will help save lives. We recently interviewed three of our physicians who actively enroll patients in clinical research to provide information about the latest in clinical research. Dr. Oscar Goodman is the medical director of CCCN’s research program and specializes in treating genitourinary malignancies. Dr. Fadi Braiteh focuses his treatment and research on gastrointestinal malignancies, lung cancer, breast cancer, and Immunotherapy. And Dr. Nicholas Vogelzang has a particular interest in genitourinary malignancies, Mesothelioma, and clinical research.
Dr. Oscar B Goodman, Jr.
Dr. Nicholas Vogelzang
Dr. Fadi Braiteh
- What is a clinical trial and how does it work?
Dr. Oscar B Goodman, Jr. (OBG): Clinical trials allow new therapies (or medical devices) to be evaluated prior to Food and Drug Administration (FDA) approval. These options have generally been tested and evaluated in laboratory models with promising results. For patients, they allow access to treatments otherwise unavailable, and they provide hope by offering new forms of therapies to combat human disease.
Dr. Nicholas Vogelzang (NV): The advances that we’ve made in cancer treatment and the medicines that we have today have been developed from clinical trials. In a clinical trial, we will ask a patient to take a new drug, compare a new drug to an old drug, or take an old drug and add a new drug to that. Clinical trials also compare two standard drugs. However, clinical trial research is changing rapidly. There are two new types of clinical research being conducted. One new way is through Bayesian, or adaptive clinical trials, where you pick the best drug over time. The second way is through diagnostics, where patients are only able to get the drug if they have a certain genetic characteristic.
Dr. Fadi Braiteh (FB): A clinical trial, also referred to as a clinical study, is a type of scientific research study that tests how well new medical approaches, or new drugs, will work in humans. These studies test new methods of prevention, diagnosis, or treatment of a disease, such as cancer.
- What are the different phases of clinical trials?
OBG: Phase I is typically a first in human study to assess whether a drug is safe and to identify its appropriate dose moving forward. Phase II- uses the phase I dose to assess whether a drug is effective and worthy of further evaluation. These trials may be randomized against another treatment option in a blinded (unknown what is being administered) or unblinded (open label, with knowledge of what treatment is being administered). Phase III assesses whether the drug is better than the pre-existing standard of care, typically using criteria such as survival benefit or prevention of disease progression, are always randomized against the standard of care. Phase IV asses the drug for ongoing safety concerns after FDA approval.
NV: Currently, clinical research trials are organized into four phases – Phase I, Phase II, Phase III, and Phase IV. Each phase tests for different things; however, the research landscape is changing so rapidly that these numbers are going to go away. In a Bayesian trial or a randomized trial, they are not the traditional Phase I, II or III anymore. For example, we are doing Phase I trials for specific patient populations, when before, Phase I was available for everyone.
FB: A new drug or device is evaluated in the laboratory, often over years; in what is referred to as “pre-clinical trials.” This type of research does not include human subjects. After the pre-clinical phase, there are four different phases of a clinical research process that aim to answer specific questions about whether a new treatment will work well and if it’s safe. Phase I trials test the newest concept drugs in humans to find the best way to give the new treatment as well as the best dose. This phase tests the early evidence of efficacy. Phase II trials tests what effect the new treatment has on the disease. Phase III trials, typically much larger than I and II; compare the results of people taking a new treatment versus the results of people taking the standard of care. Phase IV trials are given after a drug is approved by the FDA and made commercially available. This phase checks for the occurrence of certain side effects, and detects the adverse events that are very rare and not witnessed in the phase III trial. Typically, a drug is made commercially available after a phase III trial. But in certain diseases, such as certain cancers, they can be made available after phase II if the trials show great results.
- Why are clinical trials important to cancer treatment?
OBG: Clinical trials are critical to providing treatment options, particular for incurable diseases. Our future cancer cures will come exclusively through clinical trials.
NV: Conducting clinical trials is the only way the FDA will grant new drug approval in the United States or in the world, so it’s very important. Some people might fear clinical trials because they don’t know enough about it. It’s important to note that new drugs being developed through clinical research have far fewer side effects than older drugs.
FB: Clinical trials are important for any treatment. It is the only way to test new drugs and to demonstrate that they are helpful. This is the only scientific research method that will prove such efficacy. Clinical trials are heavily regulated and supervised by ethics, scientific and governmental agencies. They are delivered by specifically trained investigators to ensure patients safety.
- Who can participate in clinical trials?
OBG: Any individual who can provide informed consent (i.e. understand the potential risks, benefits, and alternative treatment options) and meets eligibility requirements (e.g. has the appropriate diagnosis and intact organ function) can participate.
NV: Anyone who has cancer, but also has good kidney function, good liver function and good blood function. We have to do a checklist of eligibility criteria before we can conduct a clinical trial.
FB: Any patient with a specific condition can participate in a clinical trial, when available. These trials are designed so a patient will receive nothing less than the best standard of care that is available. In a trial, there is no compromise on medical care a patient receives.
- What are the risks associated with clinical trials?
OBG: Risk depends on the trial phase (typically higher for phase I since there is less extensive experience with the drug or device) and the emergence of any unknown side effects.
NV: There are always new drugs being developed. They claim there are no side effects, but they do have some. However, through clinical research, we are able to identify those side effects and make modifications to the drugs. Sometimes the drug might not be the right dose, or it might affect humans differently. There’s a fair bit of science that doesn’t translate into the human experience, which may expose them to side effects.
FB: Participation in a clinical trial itself has no risks, and in fact, studies show the quality of care given to a patient on a trial is often better. The risk is related to the new drug being studied, however, patients are well aware of the risks. Part of the enrollment process is to review, understand and accept the risks associated.
- Will my clinical trial treatment be given by qualified physicians and staff?
OBG: Yes, this is mandated by the FDA. Since trials involve non-approved therapies, there is very extensive FDA-mandated oversight to assure patient safety. A full team of medical professionals including physicians, nurses, and research staff will monitor the patient and care for them through the duration of treatment.
NV: Yes. All doctors who participate in clinical trials have to sign an agreement with the company developing the trail that they will follow the letter of the law, in this case, the trial protocol. Clinical trials call for experienced doctors who are willing to communicate with the company on a regular basis which means agreeing to follow the protocol, joining regular calls, monitoring the patient and doing a very careful job. At CCCN, we have an entire team dedicated to research which includes the physician, clinical research coordinators, data managers, regulatory specialists and financial specialists.
(FB): Yes, the provider administering the study must be licensed to practice medicine in her/his subspecialty. Additionally, the research staff and the physician must have extensive training, must pass evaluation for conducting clinical trials, and have specific training for each trial individually.
Read Clinical Trial Research Q&A – Part 2 to learn more.