Frequently Asked Questions by our Patients
What is clinical research?
Clinical research involves methods of investigating new approaches to treatment or ways of understanding health conditions or disease. One method is through clinical trials, which generally involve a novel medication, device, or form of treatment. Some research studies seek to gain a better understanding of a patient’s attitudes and behaviors as well. Regardless, participation in research studies and/or clinical trials is entirely voluntary.
A clinical trial is a type of research study to assess a new approach to treatment or understanding of a health condition or disease. This approach could involve a medication, device, treatment protocol, or a participants’ attitudes or behaviors. Participation in research studies and clinical trials is entirely voluntary.
Is Baptist Health involved in clinical trials?
Yes, we are. Clinicians in Baptist Health facilities are currently engaged in more than 200 clinical trials, addressing a variety of medical conditions and concerns.
Some of our areas of interest (or expertise) include:
- Cancer
- Heart disease
- Orthopedics
- Neurological disorders
- Stroke
- Communicable diseases
- Obstetrics
Studies are being conducted in several of our Kentucky locations, including facilities in Louisville, Lexington, Paducah, Corbin, Madisonville, Richmond, and Elizabethtown, as well as New Albany, Indiana.
Our dedication in clinical research is directly linked to our organizational mission of serving the healthcare needs of patients and communities across Kentucky and Southern Indiana.
Do Baptist Health patients sometimes participate in clinical trials?
Yes. Many of our patients have participated in clinical trials.
What are the benefits of participating in a clinical trial?
Participating in a clinical trial can result in a number of potential benefits. These include:
- Playing an active role in managing your personal health.
- Access to new and innovative medical treatments long before they become generally available.
- Receiving care in an environment with a high degree of medical oversight (based on the need to uphold the study’s scientific rigor).
- Being a pioneer in introducing a breakthrough medical technology or drug to the public.
How are individuals identified for clinical trials?
People become interested in clinical trials in a variety of ways. Sometimes a potential participant with a particular medical condition makes inquiries after hearing about a trial from a friend or another source. Other times, this person is approached by a physician, nurse, or other member of their care team who thinks that he or she might be a good fit for an upcoming study.
Every potential participant is evaluated for eligibility. Each clinical trial has criteria for determining who can participate. A document called the study protocol lists these criteria. The guidelines are based on personal characteristics, such as age and sex, health status, family history, and the nature and progression of the medical condition being researched. At Baptist Health, a research coordinator will take time to discuss your options and preferences, review your medical record, and speak with your physician regarding your suitability.
If I have an opportunity to participate in a clinical trial, what should I know beforehand?
Participation in any clinical trial is voluntary. If you choose to take part, a member of the research team will go through the informed consent process with you. A Baptist Health research coordinator will explain the project to you. Detailed information about the study is also outlined in the Informed Consent process.
This process is to ensure that before you decide to take part in a study, you are provided with the information necessary to make an informed decision, such as:
- the purpose of the study,
- the procedures, drugs, or devices being researched,
- how the treatments being evaluated differ from current forms of care,
- any potential risks and discomforts you may experience,
- the possible benefits of participating, and
- what is expected of you as a participant.
Please ask the research coordinator or someone from the investigative team to explain any words or concepts that you do not understand. You may take home an unsigned copy of the Informed Consent Form to discuss your decision with family or friends. If you choose not to participate in the trial, be sure that you understand your treatment alternatives.
What is informed consent?
Informed consent refers to the agreement made by a participant to enroll in a clinical trial only after being provided with all the information that he or she needs to decide based on rational self-interest. The Baptist Health informed-consent process is designed to provide this information, which will encompass the nature and scope of the research, possible medical benefits and risks, and participant obligations and safeguards under the agreement.
How do you assess/ monitor safety in clinical trials?
By law, every clinical trial is monitored by an Institutional Review Board, or IRB. A typical IRB is comprised of at least five individuals of varying backgrounds, some in science, some in medical ethics, and some in other relevant professional fields. It is empowered by federal regulations to ensure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating in research. The IRB is a safety watchdog, reviewing the structure and progress of the research project, and stepping in when necessary to control the level of risk. Every clinical trial in which Baptist Health participates has a designated IRB.
Are there potential risks associated with a clinical trial?
Patient safety is a priority in everything we do at Baptist Health. No clinical trial can be entirely risk free. Any drug, device, or medical treatment can have side effects, some of which are unwanted. Some potential side effects are known beforehand and can be managed accordingly; others may emerge unexpectedly during the course of the trial. Baptist Health will provide every trial participant with a complete overview of known risks prior to his or her involvement in the research project.
How long does a clinical trial typically last?
The length of a clinical trial varies according to the nature of your medical condition and the types of medications and technologies being investigated. Research that addresses chronic conditions will typically require a longer study period than those that react to fast-acting drugs or innovative new forms of medical intervention.
Will it cost me money to take part in this research?
Typically, any care you receive for your condition during a clinical trial, that you would have received regardless, will be billed to you or your insurance company, Medicare, or Medicaid. This includes the costs of hospitalization, inpatient and outpatient procedures, physician fees, imaging and technical exams, lab tests, and medications. You will be responsible for any out-of-pocket costs, such as copays and deductibles, that your insurer doesn’t cover. It is possible, however, that some of these costs may be paid for by the sponsor (the company or individual that initiates and manages the trial). The research coordinator will discuss the potential financial impact with you before you decide to participate.
Can I withdraw my consent for participation in a clinical trial?
Yes. Your decision to take part in a study is voluntary. If you decide that you no longer want to take part in the trial, contact the study’s principal investigator or research coordinator and let him or her know. You will not be penalized in any way, nor will you lose any benefits to which are rightly entitled. Leaving a study will not impact any aspect of your future healthcare.
I want to learn more about Baptist Health clinical trials. What should I do?
If you are interested in learning more about clinical trials, please contact our Research team by completing our form. Or, you may call our office, or speak to your provider.
Lisa Sikora
Administrative Assistant