Clinical Trials
Where will tomorrow’s innovations come from? Who will help discover the next breakthrough in cancer treatment, or perhaps the next cure?
The answer lies in research, and at Owensboro Health, it’s a key part of our vision. That is why we offer opportunities for our patients to participate in clinical trials created by some of the most innovative organizations in the nation - universities, pharmaceutical companies and research institutions.
Through our active participation in important clinical trial networks, patients have access to some of the world’s most advanced treatment options right here in Owensboro.
Our network affiliations include University of Kentucky Markey Cancer Center Research Network and SWOG Cancer Research Network.
By participating in clinical trials, patients receive world-class treatment and are also involved in important research that could help change the way diseases are treated in the future.
Contact Us
Email: ClinicalTrials@owensborohealth.org
- Vanissa Sorrels - Clinical Research Specialist
270-691-8094
What is a clinical trial?
A clinical trial is a research study that involves people to evaluate the effectiveness of a therapeutic, invasive, surgical or care management intervention through the process of randomization assigning each subject to treatment group by chance in order to balance known and unknown treatment variables that may influence the disease process and response to treatment.
Phases
Phase I
In a phase I clinical study, the investigational new drug is tested for the first time in human subjects for the purpose of evaluating the safety of the drug. The safety profile of the investigational agent is determined by monitoring the metabolism and pharmacologic actions of the drug and determining the maximum tolerated dose in a small population of subjects (20 to 80). (21 CRF 312.21(a)
Phase II
In a phase II clinical trial the purpose of the study is to evaluate the effectiveness and safety of the investigational drug in a larger group of patients (typically 100 to 300) by determining the most effective tolerated dose and monitoring common side effects and risks associated with the drug. (21 CRF 312.21(b)
Phase III
In a phase III clinical trial the investigational drug has demonstrated effectiveness and the main purpose is to obtain additional information regarding the drug’s safety and effectiveness that is needed for evaluating the risk and benefit of the drug which is necessary for the labeling and marking of the drug. Typically phase III trials are large (300 to 1000 patients) randomized, multi-center trials. (21 CRF 312.21(c)
Phase IV
In a phase IV clinical trial the study is conducted after the product has been approved by the FDA for the purpose to gain additional information about the drugs risks, benefits, optimal use and evaluation of the drug in different patient populations. (21 CRF 314.80)
Am I eligible?
Based on the questions the research is trying to answer, each clinical trial protocol clearly states who can or cannot join the trial.
Common Criteria for Entering a Trial
- Having a certain type or stage of cancer
- Having received a certain kind of therapy in the past
- Being in a certain age group
Criteria such as these help ensure that people in the trial are as alike as possible. This way doctors can be sure that the results are due to the treatment being studied and not other factors.
These criteria also help ensure:
- Safety: Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to be sure that you are not put at increased risk.
- Accurate and meaningful study results: You may not be able to join some clinical trials if you already have had another kind of treatment for your cancer. Otherwise, doctors could not be sure whether your results were due to the treatment being studied or the earlier treatment.
Randomization
Randomization is a process used in some clinical trials to prevent bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatments being tested. Randomization helps ensure that unknown factors do not affect trial results.
If you participate in such a trial, you will be assigned by chance to either an investigational group or a control group. Your assignment will be determined with a computer program or table of random numbers.
- If you are assigned to the control group, you will get the most widely accepted treatment (standard treatment) for your cancer.
- If you are assigned to the investigational group, you will get the new treatment being tested.
Comparing these groups to each other often clearly shows which treatment is more effective or has fewer side effects. If you are thinking about joining a randomized clinical trial, you need to understand that there is an equal chance you will be assigned to either group. Neither you nor the doctor chooses the group you will be in.
Will I get a placebo?
A placebo is designed to look like the medicine being tested, but it is not active. Placebos are almost never used in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.
Federal rules help ensure that clinical trials are run in an ethical manner.
Whenever you need treatment for your cancer, clinical trials may be an option for you. Choosing to join a clinical trial is something only you, those close to you, and your doctors and nurses can decide together.