These frequently asked questions and answers will provide basic information about clinical research and how you can participate in a study conducted at the University of Iowa.
A clinical trial is a research study in which human volunteers (participants) are assigned to one or more interventions to help answer specific questions about new ways to prevent, diagnose, and treat diseases. Clinical trials allow researchers to work with patients with the exact condition they are trying to treat.
Clinical research is medical research that involves people to test new treatments and therapies. This type of research may test the effectiveness and/or safety of medications, medical devices, or other treatments. Some research studies are designed to observe and measure outcomes without having researchers affect the routine medical care of the volunteer.
Clinical trials take place in phases, and each phase helps researchers answer specific questions.
People with specific diseases or conditions and healthy volunteers can participate in clinical trials.
At the beginning of the trial, you will participate in the informed consent process and then the research team will assess your eligibility to participate.
They may check the health of each participant, take baseline measurements and give specific instructions about participating in the trial. The research team will monitor each participant at follow up visits and through surveys and interviews throughout the study. Some clinical trials involve more tests and doctor visits than you would normally have for an illness or condition.
Yes. Most clinical trials provide short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.
After all participants have completed the study and all data collected from the trial are entered, the data is analyzed to determine the answers to the specific health questions posted by the study. The types of questions to be answered depend on the purpose of the study.
All medical research involves some risk. The risks and benefits are different for each clinical trial, so it is important that you talk to members of the research team before making a decision.
They can tell you about the known risks and benefits of the specific trial you are considering, as well as other available treatment options to help you and your loved ones decide whether or not to participate.
Every clinical trial has guidelines on who can participate, called eligibility criteria. To determine if you are eligible, study staff may screen you to see if you could participate if interested. In addition to the specific disease of condition, other criteria may include age, gender, previous treatments, and other known medical conditions or family medical history.
The length of a clinical trial or research study is different depending on the study. When volunteering for a trial, you will be told the duration before you decide to participate.
Clinical research and trials help researches learn about the safety and effectiveness of all drugs, procedures, and other treatments. Medical advances like new drugs and surgical procedures are possible because of clinical trials and the voluntary participation of individuals.
The Office of Human Research Protections (OHRP) in the U.S. Department of Health and Human Services provides informational videos, a list of questions to ask and information about the protection of research participants and some additional resources.
The National Institute of Health (NIH) also provides a list of questions (from Cancer.gov) that you should ask to decide whether to participate in a clinical research study or trial.
There are several national and University of Iowa websites that provide information about clinical trials, including:
Please visit the Resources section of the website.
1. ClinicalTrials.gov Glossary of Terms
2. National Institutes of Health Glossary of Common Terms
3. Office of Human Research Protections pages About Research Participation