Through clinical trials, the newest, most promising medications, medical devices, and treatment protocols are made available to patients.
The Hawai‘i Pacific Health Research Institute (HPHRI) is dedicated to supporting clinical trials within the Hawai‘i Pacific Health network of hospitals — Kapi'olani Medical Center for Women & Children, Pali Momi, Straub Clinic & Hospital, and Wilcox Memorial Hospital. We participate in more than 200 clinical trials a year working with more than 70 principal investigators.
What are clinical trials?
Clinical trials are research studies that involve people. The main purpose is to find a better way to prevent, diagnose, or treat a disease. Clinical trials are part of a long, careful research process. Patients who participate in a clinical trial receive drugs or procedures that already have been researched in successful laboratory and/or animal studies. Most clinical trials investigate new drugs or procedures.
All patients who participate in clinical trials are volunteers. They can choose to stop participation in the clinical trial at any time.
What are the different types of clinical trials?
Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
What are the different phases of clinical trials?
Most clinical trials involve the testing of a new drug. These studies are conducted in a step-by-step progression organized by phases. This organization scheme ensures reliable data and patient safety.
Pilot: The drug or treatment is given to one or a very small number of participants and acts as a first look to test an idea. This type of study requires very careful observation and is designed to be completed in a short time period.
Phase I: Researchers test a new drug or treatment in a small group of people (20-80) 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 (100-300) 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 (1,000-3,000) 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 additional information on the drug's effect and any side effects associated with long-term use.
Why participate in a clinical trial?
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.
Who can participate in clinical trials?
All clinical trials have guidelines about who can participate in a study. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. The guidelines for participation in a clinical trial vary from study to study.
Factors that allow you to participate in a study are called "inclusion criteria". Factors that keep you 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 help researchers ensure they will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. 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.
Who are members of the clinical trial team?
Principal Investigator: The principal investigator, usually a doctor, is responsible for the design, development and conduct of the clinical trial. He or she evaluates data and helps participating doctors manage the trial. You will continue to see your primary doctor if he or she is not the principal investigator.
Study Coordinator: The study coordinator directs and coordinates patient care during a clinical trial, and is a good contact for patients who have questions. He or she will:
- Teach you about participation in the clinical trial
- Make sure the study instructions are followed
- Teach you about side effects
- Help manage clinical trial data
What are the benefits and risks of participating in a clinical trial?
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.
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.
Participation in research may require more time and attention than would a non-research treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of participants protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Does a participant continue to see their regular doctor while in the trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the research treatment.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Every clinical trial in the U.S. 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 IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. HPHRI uses the Western Institutional Review Board (WIRB®) to approve and monitor all ongoing research studies.
What are my rights as clinical trial participant?
Once you decide to enroll in a clinical trail and consent to participate you should:
- Be told the purpose of the study and allowed to ask any questions about the trial before giving consent and during the course of the trial
- Be told of all of the risks and benefits participation in the study
- Be told what will happen in the study and if any investigational treatments are different from standard medical treatment
- Be told about available treatment options that may be better or worse than being in a clinical trial
- Be allowed ample time to decide if you want to participate
- Receive a signed and dated copy of the informed consent document
- Be told of any medical treatment available to you if complications occur during the trial
What are some questions to ask before deciding to participate in a clinical trial?
- What is the purpose of the study?
- Why do the researchers think the approach being tested may be effective? Has it been tested before?
- Who is going to be enrolled in the study?
- Who is sponsoring the study?
- Who has reviewed and approved the study?
- What are the medical credentials and experience of the researchers and other study personnel?
- How are the study results and safety of participants being monitored?
- How long will the study last?
- How will the results of the study be shared?
Possible Risks and Benefits
- What are the possible short-term benefits?
- What are the possible long-term benefits?
- What are the short-term risks, such as side effects?
- What are the possible long-term risks?
- What other treatment options are available?
- How do the possible risks, side effects, and benefits of the trial compare with the participants current treatment?
- Does the study involve a placebo or treatment that is already on the market?
Participation and Care Issues
- What kinds of treatment, medical tests, or procedures will occur during the study? How often will patients receive the treatments, tests, or procedures?
- Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
- How do the tests in the study compare with regular treatment for people outside of the study?
- Will participants be able to take their regular medications while in the clinical trial?
- Where will the participants receive their medical care?
- Will participants require hospitalization? If so, for how long?
- Who will be in charge of the participants’ care? Will they be able to see their own doctors?
- How long will participants need to stay in the study? Will there be follow-up visits after the study?
- What type of long-term follow up care is part of the study?
- How could being in the study affect the participants’ daily lives?
- What support is available for participants and their families?
- Can potential participants talk with people already enrolled in the study?
- What is the process for withdrawing from the study?
- How will the participant know if the treatment is working?
- If the treatment works for me can I keep using it after the study?
- Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
- What is health insurance likely to cover?
- Who can help answer questions from the insurance company or health plan?
- Will participants be reimbursed for any other study related expenses?
Links to Other Resources