University Hospitals (UH) receives numerous inquiries each month requesting information on Clinical Trials.
A Clinical Trial is a research study to answer specific questions about new therapies or new ways of using established treatments. Clinical Trials are used to determine whether new drugs or treatments are both safe and effective. Most current drug therapies were initially developed in past Clinical Trials.
Participants include men, women and children of all ages, races, religions and ethnic backgrounds, depending on the study guidelines. Protection of the rights, safety and welfare of our research participants is always our primary concern. Clinical Trial participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Each Clinical Trial is approved by the Institutional Review Board consisting of healthcare professionals as well as lay people from the community to ensure that risks are monitored and federal regulations are followed.
If you would like to participate, please note that each trial is listed with study-specific contact information. You may also enroll online by selecting the "Enroll in Clinical Trials" link at the left of this screen.
We hope you find this brochure useful, and that you will share it with friends and family who may benefit from one of the studies.
Nathan Levitan, MD
Chief Medical Officer
University Hospitals
To view/download our brochure on clinical trials, click here
Q & A About Clinical Research Studies
What is a clinical research study?
A clinical research study:
Answers specific questions about therapies
Explores new ways of using known treatments
Determines treatment safety and effectiveness in humans
Who can participate in a clinical research study?
The clinical research study protocol outlines the study criteria for participation.
Study criteria may include (but are not limited to) age, medical history, disease type, and current medications.
What are the potential benefits of clinical research study participation?
Potential benefits include:
Better access to new medications and interventions prior to wide availability
More active role in personal health care
Potentially improved health status should the study therapy prove effective
Unique opportunity to help others by contributing to clinical research
What are the potential risks of clinical research study participation?
Potential risks include:
Unchanged health status
Worsened health status due to study therapy side effects
Insufficient health care coverage to cover clinical research study participation costs (if applicable)
What protection is offered to clinical research study participants?
The federal government imposes strict guidelines and safety standards to protect clinical trial research participants.
An institutional review board (IRB) (an independent committee of health care professionals and community lay persons) is responsible for ensuring that clinical research is both scientifically and ethically sound.
Should I participate in a clinical research study?
The decision to participate is voluntary.
Should you decide to participate, you do so as a volunteer.
As a volunteer, you reserve the right to refuse study treatment at any time.
Can I leave a clinical research study after it has begun?
As a research volunteer, you have the right to terminate your participation at any time.
For safety reasons, however, a follow-up visit may be required.
What if I choose not to participate in a clinical research study?
You reserve the right to refuse to participate in a clinical research study.
Your decision to refuse participation will not affect your health care.
I am interested in participating in a clinical research study. Which questions would I ask?
Sample questions include:
Who
Who is conducting the research study?
Who is sponsoring the research study?
Who will be responsible for my care?
What
What is the purpose of the research study?
What are the potential benefits/risks?
What are the clinical research study-related costs?
What is the overall time commitment?
What are my other treatment options?
Will
Will I be able to continue visiting my primary care physician?
Will any clinical research study follow-up be provided?
Will my health insurance cover these study-related costs?
How
How does the research study therapy compare to other treatment options?
How often are clinical research study-related visits conducted?
How long will the clinical research study last?
How do I end my clinical research study participation in the event that I change my mind?
Glossary of Terms
Blinded (masked) study: Participants do not know whether they are in the experimental or control group in a research study
Control Group: While one group receives the experimental therapy, the control group receives either the standard therapy or a placebo.
Double-Blinded (Double-Masked) Study: Neither the study participants nor the study professionals know which participants are receiving the test therapy and which participants are receiving standard therapy or placebo.
Institutional Review Board (IRB): An IRB is an independent committee of physicians, nurses, pharmacists, scientists, ethicists, and community advocates. Every clinical trial conducted in the United States requires IRB approval and monitoring to protect each participant's rights and welfare.
Phase: Clinical trials of experimental drugs progress through four phases:
In Phase I clinical trials, researchers test a new drug or therapy in a small group of participants (20-80) for the first time to evaluate treatment safety, determine proper dosage, and observe side effects.
In Phase II clinical trials, researchers administer the study drug or therapy to a larger group of participants (100-300) to further evaluate both its safety and effectiveness.
In Phase III clinical trials, researchers administer the study drug or therapy to large groups of participants (1,000-3,000) to confirm effectiveness, identify risks, monitor side effects, and compare and contrast study treatment safety and effectiveness with commonly used therapies.
In Phase IV clinical trials, researchers continue testing the study drug or therapy in order to measure treatment effectiveness and monitor the effects of long-term use.
Placebo: A placebo is an inactive substance that holds no treatment value. In clinical trials, the experimental therapy is often compared to the placebo to measure treatment effectiveness.
Protocol: A protocol outlines the specifics of the clinical trial, namely, study qualifications, time points, treatments, and procedures.
Side Effects: Side effects are any undesired actions or effects caused by the study drug or therapy.