The information gained from these clinical trials helps researchers find out if these new medicines and/or treatments are safe for humans to use and if they produce the intended effect.
All clinical trials have guidelines about who can participate.
Before joining a clinical trial, a volunteer must qualify for the study.
The factors that allow volunteers to participate in a clinical trial are
called “inclusion criteria” and the factors that disallow volunteers from
participating are called “exclusion criteria.”
These criteria may include:
TYPE OF DISEASE
STAGE OF DISEASE
PREVIOUS TREATMENT HISTORY
OTHER MEDICAL CONDITION
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. Inclusion and exclusion criteria identify appropriate participants, promote participant safety, and ensure that researchers learn the information they need.
We encourage anyone with questions
to call the Patient Recruitment Office at:
Interested in an Enrolling Study?
See if you qualify today.
Frequently Asked Questions
Clinical studies are research studies in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) are a means of developing new treatments and medications for diseases and conditions. There are strict rules for clinical trials, which are monitored by the U.S. Food and Drug Administration. Some of the research studies at Asclepes research involve promising new treatments that may directly benefit patients.
The health of millions has improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Clinical trial volunteers participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.
Possible benefits for volunteers:
- Play an active role in their health care.
- Gain access to research treatments before they are widely available
- Obtain medical care at health care facilities during the trial.
- Help others by contributing to medical research.
Asclepes research compensates study participants for their time and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant’s time, whereas the study’s principal investigator determines inconvenience rates. Asclepes research reports compensation of $600 or more to the Internal Revenue Service and sends a “Form 1099-Other Income” to the participant at the end of the year.
A “healthy volunteer” or “clinical research volunteer” is a subject with no known significant health problems who participates in research to test a new drug, device, or intervention. The clinical research volunteer may be a member of the community or a family member of a patient volunteer. Research procedures with these volunteers are designed to develop new knowledge, not to provide direct benefit to study participants. Clinical research volunteers have always played a vital role in medical research. When developing a new technique, such as a blood test or imaging device, we use clinical research volunteers to define the limits of “normal.” These volunteers serve as controls for patient groups and are often matched to patients based on characteristics such as age, gender, or family relationship. They are then given the same test, procedure, or drug the patient group receives. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.
The phase I study is used to determine the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase I studies typically offer little or no benefit to the volunteer subjects.
The phase II study involves a drug that has well-known dose and side effects. Many more volunteer subjects are tested in phase II studies than in phase I studies. Phase II studies define side effects, identify how the drug is used in the body, and elucidate how it helps the condition being studied. Some volunteer subjects may benefit from a phase II study.
The phase III study compares the new drug with a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find the new drug’s suitability to manage a particular condition. Determining the true benefit of a drug in a clinical trial is difficult.
Placebos are harmless, inactive substances made to look like the real medicine used in the clinical trial. Placebos allow the investigators to learn whether the medicine being studied works better than ordinary treatment. Many studies have successive time periods with either the placebo or the real medicine. To avoid introducing bias, the patient and sometimes the staff are not told when or what the changes in medicine are. If a placebo is part of a study, you will always be informed in the consent form given to you before you agree to take part in the study. When you read the consent form, be sure you understand what research approach is being used in the study you are entering.
Medical research is dogged by the placebo effect–the real or apparent improvement in a patient’s condition due to wishful thinking by the investigator or the patient. Medical techniques use three ways to rid clinical trials of this problem: randomization, single-blind or double-blind studies, and use of a placebo. These methods have helped discredit some previously accepted treatments and validate new ones.
Randomization is when two or more alternative treatments are selected by chance, not by choice. The treatment chosen is given with the highest level of professional care and expertise, and the results of each treatment are compared. Analyses are done at intervals during a trial, which may last years. As soon as one treatment is found to be definitely superior, the trial is stopped. Thus, the fewest number of patients receive the less beneficial treatment.
In single- or double-blind studies, the participants don’t know which medicine is being used and can describe what happens without bias. Blind studies are designed to prevent anyone (doctors, nurses, or patients) from influencing the results. This allows for scientifically accurate conclusions. In single-blind (“single-masked”) studies, only the patient is not told what is being given. In a double-blind study, only the pharmacist knows; the doctors, nurses, patients, and other health care staff are not informed. However, it is always possible to find out what the patient is taking if medically necessary.
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort that last only a short time. However, some volunteer subjects experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in research, the knowledge developed may help others.
The following section describes safeguards that protect the safety and rights of volunteer subjects. These safeguards include:
- The Protocol Review Process
- Informed Consent Procedures
- The Patient Representative
- The Patient Bill of Rights
Protocol review. As in any medical research facility, all new protocols produced at ASCLEPES RESEARCH must be approved by an institutional review board (IRB) before the study can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.
Informed consent. Your participation in any Clinical Center research protocol is voluntary. For every study in which you intend to participate, you will receive a document called “Consent to Participate in a Clinical Research Study” that explains the study in straightforward language. A member of the research team will discuss the protocol with you, explain its details, and answer your questions. Reading and understanding the protocol is your responsibility. You may discuss the protocol with family and friends. You will not be hurried into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. You are free to change your mind and not participate furtherat any time after signing the protocol. This means you are free to withdraw from the study completely or to refuse particular treatments or tests. Sometimes however, this will make you ineligible to continue the study. If you are no longer eligible or no longer wish to continue the study, you will return to the care of the doctor who referred you to Asclepes research.
Patient representative. The Patient Representative acts as a link between the patient and the hospital. The Patient Representative makes every effort to ensure patients are informed of their rights and responsibilities and they understand what the Clinical Center is, what it can offer, and how it operates. We realize that this setting is unique and may generate questions about the patient’s role in the research process. As in any large and complex system, communication can be a problem and misunderstandings can occur. If any patient has an unanswered question or would like to discussa problem, they can call the Patient Representative.
Bill of Rights. Whether you are a clinical research or a patient volunteer subject, you are protected by the California Patient Bill of Rights. The bill of rights concerns your received care, privacy, confidentiality, and access to medical records.