Welcome to Clinical Trials Resources
At any one time, there are more than 30 cancer trials available for Kaiser Permanente patients within our Oncology Clinical Trials Program. Every year, more than 300 Kaiser Permanente patients in Northern California enter oncology clinical trials, where they may be able to participate in new cancer treatments even before they are FDA approved and available to the general medical community.
95% of the clinical trials offered at KP are multi-center trials being conducted at university medical school cancer centers and other cancer treatment research centers across the United States. Kaiser Permanente participates in national trials through several national cooperative research groups such as:
and certain pharmaceutical industry sponsored studies.
Most people are not aware that Kaiser Permanente in Northern California is a major participant in these organizations and their trials.
Understanding Clinical Trials
Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
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Phase I - Experimental treatments are evaluated to determine the best dosage and evaluate for side effects. Many treatments do not progress past phase I.
Phase 2 - Once dosage and side effects are known, trials are conducted to get an idea if the new treatment has beneficial effect (a response rate) in a certain disease. More toxicity information is learned.
Phase 3 - The new therapy is compared to the current standard therapy in a randomized trial to see which therapy is better.
Phase 4 - After a therapy or drug is approved and felt to be a standard therapy, many more cases are reviewed in order to detect uncommon side effects or outcomes.
Kaiser Permanente, Northern California participates in mostly phase 3, and some phase 2 trials.
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Risks
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
To learn more, please visit the clinical trial website of National Institute of Health
Kaiser Permanente Santa Clara clinical trial team contact information:
Learn about other scientific and medical research at Kaiser Permanente:
