Glossary & Frequently Asked Questions (FAQs)
Additional answers to questions provided by the NIH - "FAQs About Clinical Studies"
What is a clinical trial?
A clinical trial is a research study intended to answer specific questions involving medications, medical devices or new ways of using known treatments. Carle conducts clinical trials to determine whether new drugs, devices or treatments are both safe and effective. All research conducted at Carle is reviewed and approved by an Institutional Review Board.
What is the purpose of a clinical trial?
Most clinical trials provide short term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the patient's healthcare provider work with the research team, the patient can ensure that other medications or treatment will not conflict with the protocol.
What are the benefits of a clinical trial?
Participants play a more active role in their own health care, can gain access to new research treatments before they are widely available and will help others by contributing to medical research. Consult your physician for advice on weighing the benefits and risks of participation.
Are there any participation guidelines?
All clinical trials have guidelines about who may or may not participate. These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before enrolling in a clinical trial, a participant must qualify for the study. No one is ever enrolled in a clinical trial without previous knowledge and written consent.
How is Carle involved in a participant’s care in a clinical trial?
Our clinical research team (doctors, nurses and other healthcare professionals) assesses the health of the participant, provides detailed instructions for the participant, monitors the participant carefully during the trial and stays in touch after the trial as needed. Occasionally, a trial may involve additional tests and doctor visits. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and determine the safety and effectiveness of the treatment.
Who regulates the clinical trial process?
The Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) develop the policies and guidelines for all medical research. An Institutional Review Board reviews and approves all study-related documents, such as protocols, informed consent forms, physicians’ credentials and eligibility and patient recruitment materials.
Glossary of Terms
Community Clinical Oncology Program (CCOP)
Created in 1983 by the National Cancer Institute (NCI), the CCOP network allows patients and physicians to participate in state-of-the-art clinical trials for cancer prevention and treatment while in their local communities. There are 47 CCOPS and 16 MB-CCOPs currently funded in 35 states across the country, and Puerto Rico.
Clinical Research Professionals (CRPs)
Clinical Research Professionals (CRPs) that work diligently to advance our mission to improve the health status and quality of life for cancer patients by providing a local access to state-of-the-art prevention and treatment trials.
A research base is a NCI-designated Cancer Center or Cooperative Group that designs, develops, and conducts cancer prevention and control clinical trials with a community-based focus.
Clinical trials are research studies that test whether new ways prevent, diagnose and treat cancer are safe and effective. These clinical trials, also called clinical studies or research protocols, are conducted by physicians with people who volunteer to take part. Frequently, they give patients access to potentially helpful therapies not widely available elsewhere.
A contract whereby one or more hospitals agrees to provide certain benefits to members of a specific health plan. In the case of Carle and its affiliation with Rush-Copley Cancer Center and Franciscan St. Anthony Health, Carle has contracted with these hospitals so that they may have access to cancer clinical trials.