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What is KPStudySearch?
KPStudySearch is a website created by Kaiser Permanente to provide updated information about clinical trials and other research conducted in Kaiser Permanente. The intent of this site is to provide information on specific studies for a wide range of diseases and conditions.
Who submits information on the clinical studies and what review takes place before information is posted on KPStudySearch?
A Kaiser Permanente researcher or his/her designee can submit study information to KPStudySearch. Once a study reviewer confirms that the submitted research project has Institutional Review Board (IRB) approval, the study submission will be reviewed and, if approved, it will be published to KPStudySearch.
Does KPStudySearch provide advice for specific medical conditions?
No, KPStudySearch does not offer personalized medical advice about specific medical conditions or treatments. The resources on this site should not be used as a substitute for professional medical care. For personal health questions, please consult a health care provider.
Where can I find a comprehensive (Kaiser Permanente and Non-Kaiser Permanente) listing of federally and privately supported clinical trials?
ClinicalTrials.gov offers up-to-date information for locating federally and privately supported clinical trials in the United States and around the world. ClinicalTrials.gov will list studies that are conducted at Kaiser Permanente and studies that are not conducted at Kaiser Permanente.
What is clinical research?
Clinical research enables doctors and researchers to find new and better ways to understand, detect, control, and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions.
What is a clinical trial?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
What is a protocol?
All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan, that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary—including details such as the criteria for patient participation, the schedule of tests, procedures, medications, and the length of the study.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.
What is “expanded access”?
Expanded access is a means by which manufacturers make investigational new drugs (IND) available, under certain circumstances, to treat patients with serious diseases or conditions who cannot participate in a controlled clinical trial. For additional information on expanded access programs, please see the
FDA website
.
How do I find information on expanded access studies on this site?
Expanded access trials can be found by searching “Expanded Access” under Clinical Trial Type in the Advanced Search.
What are clinical trial phases?
Clinical trials are conducted in a series of steps, called phases—each phase is designed to answer a separate research question.
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:
The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III:
The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV:
Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
What protections are there for participating in a clinical trial?
Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An Institutional Review Board i s a committee of physicians, statisticians, patient advocates, and other members of the community that reviews the protocol, or study plan, to ensure that the study is ethical and that participants are not likely to be harmed. An Institutional Review Board can stop a study if it appears to be causing unexpected harm to participants, or if there is evidence that the risks outweigh the benefits. An Institutional Review Board can also stop a study if there is clear evidence that the new treatment is effective, to make it more widely available.
What is informed consent?
Participation in any clinical trial is voluntary. Before anybody can participate in a study they will receive an informed consent document that explains the details of the study, including the potential risks and benefits, as well as the potential participant’s rights and responsibilities. A member of the research team will discuss the study and answer any questions so that potential participants can make an informed decision about whether or not to participate in the study. In addition, a participant has the right to ask questions throughout the course of the study and may withdraw consent (stop) at any time. The decision to volunteer for a clinical trial is a personal one and should be decided in close consultation with a health care provider, family members, and friends.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Some research studies seek volunteers with illnesses or conditions to be studied, while other trials need healthy volunteers. Factors that allow an individual to participate in a study are called “inclusion criteria”. Factors that keep an individual from participating are called “exclusion criteria”. The criteria are not used to reject people for any personal reason, but rather are used to identify appropriate participants and keep them safe. The criteria also helps researchers ensure they will be able to answer the questions they plan to study.
Who sponsors clinical trials and where do they take place?
Clinical trials are sponsored by government agencies, private organizations, pharmaceutical companies, health care institutions and individual researchers who are seeking ways to improve the health of people.
What are the benefits and risks of participating in a clinical trial?
There are both benefits and risks associated with clinical trials. The benefits include:
Gaining access to new treatments that are not yet available to the public;
Obtaining expert medical care at a leading health care facility;
Allowing patients to play a more active role in their own health care; and,
Helping others by contributing to medical research.
The risks include:
Unpleasant, serious, or even life-threatening side effects from treatment;
Treatment may not be effective for some individuals;
Extended time for traveling to the study site, receiving treatments, or hospital stays; and,
Health insurance may not cover all the study costs.
Can a participant leave a clinical trial after having agreed to participate?
Yes. Participation in a clinical trial is always voluntary and participants may leave the study at any time—whether before the study starts, during the study, or during the follow-up period.
How do I search and use KPStudySearch?
There are three different search options within KPStudySearch:
Basic Search:
This feature allows users to enter in keywords, diseases, and/or conditions to find studies.
Advanced Search:
This feature allows users to refine their search by entering in specific criteria they would like their search results to meet.
Clinical Area Search:
This feature performs a general search in the clinical area that a user has selected.
What Kaiser Permanente Regions have studies listed in KPStudySearch?
Kaiser Permanente Northern California (KPNC)
How do I search for a study in a specific region?
There are two ways to narrow down your search to studies within a specific region:
Complete a basic search and then select a region from the Filter Results by Region dropdown
Use the Advanced Search feature and filter by Region
Do I need to know medical terminology to search KPStudySearch?
No. Each search will give the results for the disease or condition based on the entered search criteria, as well as other related medical keywords. KPStudySearch has an automatic spell check to help users if they are unsure of the spelling of a word.
Are all clinical trials and research projects that enroll subjects in Kaiser Permanente listed on KPStudySearch?
While we make every effort to keep KPStudySearch up to date with all clinical trials and research projects in Kaiser Permanente, there is no guarantee that this site and its listings are complete, accurate, and/or comprehensive.
How do I sign up for a clinical trial or research project listed on KPStudySearch?
For questions regarding a particular research project listed on KPStudySearch a study contact e-mail or phone number may be listed on the bottom of a study’s information listing. KPStudySearch is for informational purposes only. Interested participants cannot sign up for studies on KPStudySearch. It is important to talk to a health care provider to make an informed decision regarding a clinical trial or research project.
Whom should I contact for more information or with other questions?
For difficulties searching or questions about KPStudySearch please go to the
Contact Us
page and submit a comment, question, or recommendation. Please use the Regional Research Site’s Contact Us Forms for general inquiries about a region’s Research Group.
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