Table of Contents
- General Information
- What is KPStudySearch?
- Who submits information on the clinical studies and what review takes place before information is posted on KPStudySearch?
- Does KPStudySearch provide advice for specific medical conditions?
- Where can I find a comprehensive (Kaiser Permanente and Non-Kaiser Permanente) listing of federally and privately supported clinical trials?
- Understanding Clinical Trials
- What is clinical research?
- What is a clinical trial?
- What is a protocol?
- What is a placebo?
- What is “expanded access”?
- How do I find information on expanded access studies on this site?
- What are clinical trial phases?
- What protections are there for participating in a clinical trial?
- What is informed consent?
- Who can participate in a clinical trial?
- Who sponsors clinical trials and where do they take place?
- What are the benefits and risks of participating in a clinical trial?
- Can a participant leave a clinical trial after having agreed to participate?
- Searching and Using the System
- How do I search and use KPStudySearch?
- Do I need to know medical terminology to search KPStudySearch?
- Are all clinical trials and research projects that enroll subjects in Kaiser Permanente Northern California listed on KPStudySearch?
- Why am I directed to TrialCheck when I search for an adult cancer clinical trial?
- Should I use the link for adult cancer clinical trials, TrialCheck, to search for children’s cancer clinical trials?
- How do I sign up for a clinical trial or research project listed on KPStudySearch?
- Whom should I contact for more information or with other questions?
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I. General Information
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What is KPStudySearch?
KPStudySearch is a website created by Kaiser Permanente’s Division of Research to provide updated
information about clinical trials and other research conducted in Kaiser Permanente North California.
The intent of this site is to provide information on specific studies for a wide range of diseases
and conditions.
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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 Division of Research 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.
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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.
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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.
II. Understanding Clinical Trials
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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.
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What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions;
for example, is a particular drug or device safe and effective? It is called an “interventional”
study because researchers give the subjects a particular intervention (i.e. a drug, placebo, or device).
In contrast, in an “observational” study, researchers do not give an intervention, but rather observe
subjects and their health outcomes.
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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.
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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.
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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.
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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 Tab.
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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.
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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
is 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.
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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.
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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.
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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.
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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.
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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.
III. Searching and Using the System
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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 that they would like to use 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.
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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.
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Are all clinical trials and research projects that enroll subjects in Kaiser Permanente Northern California listed on KPStudySearch?
While we make every effort to keep KPStudySearch up to date with all clinical trials and research projects in Kaiser Permanente Northern California,
there is no guarantee that this site and its listings are complete, accurate, and/or comprehensive. We suggest searching for adult cancer clinical
trials by using the website TrialCheck located on the KPStudySearch homepage to search for adult cancer clinical trials.
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Why am I directed to TrialCheck when I search for an adult cancer clinical trial?
Searching for adult cancer clinical trials through KPStudySearch may direct and/or connect to another website, TrialCheck, rather than providing the
study listings on KPStudySearch. The adult cancer department of Kaiser Permanente has teamed with TrialCheck to provide an institution-specific listing
of adult cancer clinical trials. We suggest searching for adult cancer clinical trials by using the website TrialCheck located on the KPStudySearch homepage.
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Should I use the link for adult cancer clinical trials, TrialCheck, to search for children’s cancer clinical trials?
At this time, only Kaiser Permanente’s adult cancer department has partnered with TrialCheck to display their studies.
Please use KPStudySearch to search for children’s cancer clinical trials.
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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.
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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 Division of Research “Contact Us Form” for general inquiries about the
Division of Research.
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