Emily Powell, PhD, Research Clinical Operations Manager, Oncology, Parkview Research Center and Lukas Gilmore, PharmD, MBA, BCPS, Clinical Research Pharmacy Supervisor, explain the criteria and process for cancer patients who wish to pursue clinical trials.
What is an oncology clinical trial?
An oncology clinical trial is a research study in which patients with cancer volunteer to test a new drug, device or procedure. The Parkview Research Center and Parkview Cancer Institute (PCI) have formed a strong partnership to bring national clinical trials to the cancer patients in our community. A team of research-specialized doctors, nurses, clinical coordinators and scientists implement these studies to learn whether a new treatment is safe and effective at shrinking tumors.
Clinical trials are extremely important for making new discoveries that lead to more effective treatments; however, fewer than 5% of adults with cancer will take part in a clinical trial. According to the American Cancer Society, in contrast, 60% of children under age 15 participate in clinical trials, which is one of the reasons that survival rates for childhood cancer have increased so dramatically in recent years.
The main reason people don’t participate in clinical trials is that they didn’t know that the studies were an option for them. Therefore, when patients are aware of and participate in clinical trials, they make important contributions that can lead to new treatments for future cancer patients, and they receive the option to receive new treatments that may even be more effective than standard treatments. However, these treatments are new and therefore carry higher risks than standard treatments.
The Parkview Research Center and PCI are running several of these studies at any given time, which allows our patients to receive the newest and most cutting-edge treatments. The opportunity to participate in these types of studies provides treatment options that are not available at centers that do not offer clinical trials.
The different types of clinical trials
Industry sponsored studies
These types of studies are sponsored by pharmaceutical companies and are geared toward testing the safety and efficacy of new drugs that are often not yet FDA-approved. These types of studies are most frequently available at large academic cancer centers; however, the Parkview Research Center regularly runs these types of studies in conjunction with research physicians at the Parkview Cancer Institute. This provides an exceptional level of care to our patients that is often unavailable in the community setting.
Cooperative group trials
Cooperative groups are networks of physician researchers who work together to address important questions and unmet needs with the goal of improving the standard of care. Examples of these types of studies include testing different combinations of FDA-approved drugs, or an FDA-approved drug in a new type of cancer. We offer a wide variety of these cooperative group trials to our patients, which not only provides additional treatment options to patients, but also frequently allows our patients and researchers to make important contributions to the advancement of science and medicine.
Investigator-initiated studies
In addition to running industry sponsored and cooperative group clinical trials, our very own Parkview physicians are working to develop their own scientific questions. These investigator-initiated studies are geared toward addressing an unmet need that is specific for our own Parkview patients.
Disease types and characteristics can vary geographically; therefore, there are sometimes gaps in the availability of national trials for certain groups of patients. When a physician scientist identifies these gaps, she or he may develop a new hypothesis and clinical trial to test the hypothesis. For example, there might be studies that were performed in mice showing that a certain combination of drugs works for a certain type of cancer. If this has never been tested in humans, and if we have the patient population that fits these characteristics, we can develop a clinical trial that may help patients benefit from this treatment.
Randomized double-blind trials
Some studies compare a new treatment to the standard of care treatment. These studies are called randomized double-blind trials. Randomized means that patients are randomly assigned to receive placebo or new drug (in addition to standard of care treatment, which is usually chemotherapy). Double-blind means that neither patient nor the researchers can tell whether the patient is receiving the placebo or the real drug. All patients receive standard-of-care in these studies, so there is no risk of them receiving sub-standard care if they choose to participate in the clinical trial.
Placebo
In clinical trials that are randomized double-blind placebo controlled trials, enrolled patients will receive either the active investigational drug or an identical looking placebo. Neither the investigator, research nurse or patient knows what treatment the patient is receiving while on therapy. However, in a medical emergency, the blind can be broken and treatment revealed if needed. In many cases the research pharmacist, however, is un-blinded since many times the research pharmacist and technician are the ones receiving the treatment randomization assignment and appropriately preparing either active or placebo.
Not all clinical trials are comparing the new investigational drug to placebo. Some trials compare the new investigational drug to a standard of care drug that is already FDA-approved to treat their disease. So, in that case they are trying to determine if the new investigational drug is better than current standard of care therapy.
It’s also important to know that some clinical trials do not include a placebo. These are called single arm studies, and in these cases, all patients receive the investigational treatment and outcomes are compared to historical standards.
Investigational Drug Service pharmacy
Investigational Drug Service (IDS) is a specialized area of pharmacy practice that provides clinical, operational and logistical pharmacy support to clinical trials involving investigational drugs ensuring safe and effective use by research participants. This protects the integrity of study data, as well as helps to ensure compliance with the Food and Drug Administration (FDA), Department of Health and Human Services (HHS), Good Clinical Practice (ICH-GCP) and The Joint Commission. These laws and regulations govern the use of investigational products in clinical trials. The Parkview IDS Pharmacy is located on the 3rd floor of Parkview Cancer Institute.
Treatment
If a patient is enrolled in oncology clinical trials and receives investigational drug treatments, either IV chemotherapy or immunotherapy, they can receive the treatment in PCI oncology infusion. Or, if the investigational drug is an oral prescription, then the medication is dispensed from the IDS Pharmacy. With clinical trials, patients’ investigational drugs are dispensed either as a prescription as an outpatient by the IDS pharmacy or administered as an inpatient if it’s an inpatient study.
The course of treatment is determined by the research study protocol, which must be followed and varies depending on the disease and the investigational drug. Typically, the course of treatment is similar to the course of treatment of other FDA-approved medications. Clinical trial treatment teams include the physician principal investigator, co-investigators, research nurse and research coordinator, research pharmacist, infusion nurse, infusion pharmacists and technicians, who all work together to ensure the patient receives the best possible care, and is safely and effectively treated with the investigational drug during the clinical trial.
Am I eligible?
The Parkview Research Center has a dedicated team of research nurses and clinical research coordinators who are constantly looking for patients who might be eligible for one of our clinical trials. The physician investigator is also constantly looking out for potential opportunities for clinical trial participation for each patient. This team reads through the medical records of each patient to learn about the characteristics of each individual’s disease, and then compares that to the criteria for enrollment on each trial. If there is a match, the physician investigator and the research nurse will present this option to the patient, carefully and clearly explaining the details of the study, the potential benefits and risks. The patient may choose to enroll in the study or decline participation based on this information.
In addition, the patients themselves can search for clinical trials online at clinicaltrials.gov, and attempt to identify studies for which they might be eligible. They can contact the Parkview Research Center to learn more.
If you are interested in learning more about an oncology clinical trial, email Emily Powell, manager of oncology clinical trials, at emily.powell@parkview.com or call at 260-266-7744.
