CLINICAL RESEARCH TRIALS

CLINICAL RESEARCH TRIALS

The KCAA Research Department is dedicated to research excellence. We have been conducting trials for almost 30 years, and we have completed over 250 trials ranging from hereditary angioedema to flu vaccines to gastroesophageal reflux disease.

Our wide-ranging research allows KCAA to help organizations worldwide and gather crucial information about treating various conditions. Jeffrey Wald, M.D. is the Research Director at KCAA. Together Dr. Wald, Dr. Neustrom, Dr. Ward and Dr. Sterner are currently lead investigators on clinical trials.

Participants in KCAA research are given detailed information about how the trial will be conducted, who qualifies, and the potential risks and benefits. The health of each participant is checked before the study and carefully monitored during the trial. Independent Institutional Review Boards (IRBs) and the Food and Drug Administration (FDA) closely observe all research to ensure safety.

We have several research studies at any given time.

If you’re interested in participating, please call the KCAA research coordinator at (913) 345-2383 or email research@kcallergy.com.

CONTACT US

Recruiting Adults & Children for Allergy and Asthma Clinical Trials

Asthma research participants must have received a diagnosis by a Physician to be eligible.

FREQUENTLY ASKED RESEARCH TRIAL QUESTIONS

What is the purpose of research?
We use knowledge gained from research to develop new treatments. Medical practice is different from research. The main purpose of medical practice is to care for the health and well-being of patients. The main purpose of research is to test new scientific ideas or new treatments.
What is a clinical trial?
KCAA doctors are involved in two types of research studies: 1) Interventional Studies (also called Clinical Trials) that test new medicines and treatments in people to gauge how well they work and ensure safety, and 2) Observational Studies that collect information about health and behavior. Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs or biological products. Clinical trials must be conducted before a new drug, biologic, or device may be marketed in the United States. The Food and Drug Administration (FDA) regulates clinical trials. The FDA gives investigators, permission to test a new drug, biologic or device under strict regulatory conditions.
What is a protocol?
A protocol describes the rules followed during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and wellbeing of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.
Who gets to be in the study?
KCAA enrolls children, adolescents, and adults. We follow strict rules regarding who may take part in research. Not everyone with the disease or problem being studied can take part. Our doctors may ask patients who could potentially qualify for a study if they wish to take part. It is up to the patient to agree to participate. A patient may drop out of a research study at any time, even if they agreed to participate. Saying “no” to participating will not change standard medical care at KCAA in any way.
What is Informed Consent?

Informed consent is the process that gives information to those thinking about taking part in the research. After learning about the research, a participant should understand the:

    • Purpose of the study
    • Procedures involved in the study
    • Possible risks and benefits of taking part
    • Rights of study participants
    • Voluntary nature of the research
    • Options instead of taking part in the study

Participants should only agree to take part after clearly understanding the study and feeling comfortable. Participants should take time to talk over the decision with doctors, family, and friends. Once the decision is reached to participate, an informed consent form will be signed. If researchers learn added information about the participant during or after the study, they must inform the participant.

Who conducts the research studies?
Every study at KCAA has a lead researcher, called a principal investigator (PI), who is a medical doctor. Some studies also have a research team that might include other doctors, nurses, research coordinators and healthcare professionals. The PI and research team closely monitor a participant’s health throughout the study.
Does it cost to participate in a research study?
No. There is no cost for the study treatments, examinations or procedures. Generally, volunteers are provided compensation to reimburse for time and travel to the office.
How long do research studies last?

The duration varies. Studies at KCAA are as short as a couple of months or as lengthy as several years. The study coordinator describes the number and frequency of visits and the length of the study.

Is my information kept confidential?
Yes. Personal identities and medical records are confidential. While participating in a study, the study doctor and study staff replaces the participant’s name with a code. Study data and blood and urine samples (if applicable) have a code, too. The list that matches the codes is kept separately at the study center.
What occurs during study visits?
That depends on the type of study. For example, some visits will include procedures such as performing a breathing test, blood draw, EKG, physical exam or skin test. Typically, a review of medical condition and medications is conducted. The study coordinator will describe which procedures will be conducted and how long the visit will last. The information can also be found in the informed consent form.
What are a study participant’s responsibilities?

Clinical study participants must agree to:

    • Follow instructions provided by the study team
    • Provide accurate and complete information about past and current medical condition
    • Carefully weigh the risks and benefits of taking part
    • Follow directions regarding non-study related medications
    • Inform the study doctor about changes in medications, illnesses or injuries, unexpected side effects or intent to have medical treatments outside of the study
    • Attend scheduled visits requested by the study team
    • Inform the study team if needing to miss an appointment
    • Inform the study team if contact information changes
    • Follow the procedures for withdrawal, if deciding to leave the study
Is there a stipend for participation?
Possibly. Most studies provide reimbursement for time and travel to the office. The study coordinator will communicate specific details, which will also be specified in the informed consent.
What types of studies has KCAA conducted?
Apart from the predictable asthma and allergy studies, we have conducted clinical trials on angioedema, chronic hives, gastroesophageal reflux disease, sinusitis, nasal polyps, atopic dermatitis and immunodeficiency to name a few.
How do I find out what research studies KCAA is enrolling for?

Call the Research Department at (913) 345-2383 or email us to inquire about our currently enrolling studies.

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