Clinical trials are research studies designed to find better ways to prevent, diagnose or treat diseases. Choosing to take part in a clinical trial is voluntary. Your choice will not affect your care or relationship with HealthPartners.
There are risks and benefits to taking part in a research study. It may or may not improve your illness. Your doctor will discuss all options available for your care. If you are interested in a research study, your care team will discuss it with you and obtain your informed consent.
Benefits of participation
You may or may not benefit from being in a research study. Your illness could improve, stay the same or get worse. We hope the information learned from the study will help other patients in the future.
New or standard treatments are not guaranteed to work, and new treatments may carry risks. But if a new treatment works as well or better than standard treatment, study patients may be among the first to receive it. Some patients get better receiving only standard treatment.
If you choose to be in a research study early on, you will have other options for treatment if the study drug, device or treatment doesn’t work. Even if you take part in a trial after you’ve had other treatments, you can usually have other treatments after the trial ends.
Research study safety
While research studies may carry risks, each one takes steps to protect patients:
Each research study has an action plan that explains how it will work. It outlines the number of participants, the medical tests they will receive and their treatment plan. Government and sponsoring agencies and ethics boards at each site must approve each plan.
Each research study enrolls people who are alike in key ways. Each study’s plan includes different eligibility criteria (e.g., age, sex, previous treatment). This helps produce reliable results and ensures that people likely to be harmed by study treatments are not exposed to them. If the new treatment works, the plan helps doctors identify the patient groups most likely to benefit.
Each participant is monitored closely. The health care team follows patients’ progress, ensuring that they receive safe care. Some studies require the health care team to keep checking on patients even after treatment ends.
Study participant rights
Informed consent is the process of giving information about the research study’s purpose, risks, benefits, alternatives and procedures to potential subjects so they can decide if they want to take part. Before signing up for a research study, you have the right to:
Learn about everything involved in the trial
Hear and read information in language you understand
You can ask questions at any time. Participation in a research study is completely voluntary.
Clinical trial phases
Each study phase answers different questions about the new treatment.
Phase I research studies are the first step in testing a new treatment in humans. In these studies, researchers look for the best and safest way to give a new treatment. They also watch for any harmful side effects.
Phase II research studies continue to test the safety and effectiveness of the new treatment. Unpredictable side effects can occur.
Phase III research studies compare a new treatment with standard treatment. Participants are randomly assigned to receive either the new treatment or standard treatment.
Phase IV research studies are used to further learn about a treatment’s long-term safety and effectiveness. These studies usually occur after the new treatment is approved for standard use.
Costs
Clinical services given during a trial are related to either research or usual medical care. The study pays for ones related to research, but not for usual medical care.
Usual care includes services medically necessary for your disease. It includes tests that would be done whether or not you were in a trial. You and/or your insurance plan are responsible for the cost of usual care, including deductibles and copayments.
Before a trial opens, the research team conducts a coverage analysis to identify research-related services and ensure that the study will cover them.
When the study ends
After a study ends, the results are often published in medical journals. If the results are very interesting, they may appear in news media and be discussed at scientific meetings. The new approach may become the standard of care.
Ask the research team if the study results have been or will be published or search for the study’s official name or protocol number in the National Library of Medicine’s PubMed database.
Participant protection
The Institute’s Research Subjects Protection Program manages two institutional review boards (IRBs). Each board reviews research with human subjects per the U.S. Department of Health and Human Services and clinical research per the U.S. Food and Drug Administration.
The IRBs advocate for research subjects and conduct ethical reviews so that:
Subjects’ rights and welfare are protected
Studies maximize possible benefits and minimize possible harms
Studies result in important knowledge
Subjects agree to participate
HealthPartners is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This group promotes high-quality, ethical research. This tells study participants, researchers, funders, regulators and the public that a program is focused on excellence.
