Overview
Holy Name Medical Center is committed to providing the most advanced therapies available to treat all diseases and conditions. Clinical trials are often the only way to access a new therapy and Holy Name's Institute for Clinical Research conducts a variety of studies that provide patients with the newest treatment options.
All studies are carefully controlled and closely monitored to ensure the safety of participants. Details of all studies may be found at the U.S. government's website, clinicaltrials.gov.
What is a clinical trial?
Clinical trials are structured procedures that determine how new medications, biologic products or devices compare to the current standard treatment. Patients are assigned, in an unbiased way, to either the new therapy or the standard form of care.
Why participate in a clinical trial?
Participants in clinical trials have access to new treatments that are not otherwise available. Many also feel that they are taking a more active role in their own health care while helping others by contributing to medical research.
How are clinical trials developed?
After researchers test new therapies in the laboratory or in animal studies, the treatments that appear promising for humans are moved into clinical trials. The trial is a highly organized way to evaluate safety and efficacy.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations, including federal agencies such as the National Institutes of Health and the National Cancer Institute, pharmaceutical companies, medical institutions and physicians. They may be conducted at multiple sites or one specific location.
What is a protocol?
A protocol is the plan the study follows. It is carefully designed to safeguard the participants' health as well as answer specific research questions. A protocol describes what types of people may participate in the trial, the schedule of tests, procedures, medications and dosages and the length of the study. It also outlines how often participants will be seen by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.
What is a placebo?
A placebo is an inactive pill, liquid or powder that has no effect on the body. In clinical trials, if there is an existing standard of care, it becomes the comparator. If there is no current therapy, a placebo is used for comparison.
What is a control group?
A control is the standard used to compare and evaluate the new treatment. In clinical trials, one group of patients will be given the treatment that the trial is focused on, while the control group is given either a placebo or a standard treatment for the disease.
What are the different types of clinical trials?
There are several types of clinical trials:
- Treatment trials - test new treatments, including drugs or combinations of drugs, techniques for surgery and approaches to radiation and chemotherapy.
- Prevention trials - explore better ways, including the use of vitamins, vaccines, minerals and lifestyle changes, to prevent a disease in people who never had that particular illness or prevent the disease from returning.
- Screening trials - test the best way to detect certain diseases or health conditions.
- Quality of Life trials - sometimes called Supportive Care trials - evaluate ways to improve the comfort and quality of life for patients with a chronic illness.
What are the different phases of clinical trials?
Every clinical trial is conducted in phases. Each phase has a different purpose to help researchers answer specific questions.
- Phase I - researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
- Phase II - a larger group of people with the targeted disease are given the study drug or treatment to see if it is effective and to further evaluate its safety.
- Phase III - researchers give large groups of people with the targeted disease the study drug or treatment to confirm its effectiveness, monitor side effects, and compare it to standard treatments, often in many sites worldwide.
- Phase IV - these studies delineate additional information, including the drug's risks, benefits and optimal use after the drug, device or therapy has been licensed.
