FAQs & Information About Our Clinical Trials
Before agreeing to participate in a clinical trial, you should have a very good understanding of the benefits and risks of doing so. The following FAQ might be helpful to you in making your decision. The US Government also has a good website that might help answer your clinical research questions regarding medical studies (http://clinicaltrials.gov/ct2/info/understand).
You may also want to talk to your own health care provider, the investigator or a study coordinator of the particular study. You may call CenExel Sherman Oaks directly at (818)-990-2671 if you have any questions or concerns, or would like to request medical study information.
Clinical research involves testing an investigational drug or device in humans. Each clinical trial must use a protocol that has been written according to government regulations and that is also approved by the company sponsoring the study. An investigational drug may be:
- a drug that has not yet been approved for marketing (i.e., a drug that is not allowed to be sold)
- a drug that is currently on the market but that is being studied for a non-approved indication or is being studied in a new route of administration, strength, or formulation;
- a drug that is being sold on the market by one company but that is being considered for in-license or acquisition by another company;
a drug that contains known and established ingredients but has not yet been marketed by the company; - a drug that is currently on the market but is being studied in a population for which the drug has not yet been approved, such as in children or in elderly patients.
Before an investigational drug or device can be studied in humans, its safety and effectiveness is carefully studied in the laboratory. However, this early research cannot predict how safe and effective the drug will be in humans. With any new treatment there may be benefits as well as known and unknown risks. Clinical research trials are conducted to determine whether promising new treatments will be safe and effective for patients.
Phase I studies involve testing the investigational drug in a small number of healthy adult volunteers. The sole objective of these studies is safety. These studies are designed to determine how the drug is metabolized by the body and what pharmacologic actions the drug has. One objective of these studies is to determine the best way to administer the drugs (i.e., the preferred route).
Phase II studies help determine how safe and effective a drug is, common short-term side effects of the drug, pharmacokinetic effects of the drug (i.e., the amount of drug that gets into the bloodstream, how quickly it gets there, and how long it stays there) and pharmacodynamic effects of the drug (i.e., the effects of the drug on the body). These studies involve a larger group of participants (e.g., 100 to 200 people) and are usually conducted in participants who have the medical condition for which the drug is being studied. These studies are used to identify the dose range of the drug that will be tested in subsequent larger studies (i.e., Phase III studies).
Phase III studies provide additional information about safety and efficacy when the drug is used in the way it is intended to be marketed. These studies are initiated only after earlier studies have demonstrated that there is an acceptable risk to benefit profile (i.e., the risk of taking the drug is outweighed by the potential benefit of the drug to the participant). These large studies are usually conducted at many different study centers; up to 10 to 30 study centers and between 500 and 5,000 participants may be included.. These studies are used to confirm the indication and best dosage for the drug.
Phase IV studies are conducted after the drug is available for sale (i.e., post-marketing studies) and they evaluate how safe and effective the drug is when exposed to the “real” population. These studies evaluate parameters such as different formulations, dosages, treatment durations, and drug interactions. The Food and Drug Administration (FDA) may require a company to conduct certain Phase IV studies as a provision for product approval. These studies may include new age groups, various races and other types of participants. These studies are useful for detecting and defining previously unknown or inadequately quantified adverse events and related risk factors. The size of these studies is broad and can range from less than 100 to over 20,000 participants.
Phase II studies help determine how safe and effective a drug is, common short-term side effects of the drug, pharmacokinetic effects of the drug (i.e., the amount of drug that gets into the bloodstream, how quickly it gets there, and how long it stays there) and pharmacodynamic effects of the drug (i.e., the effects of the drug on the body). These studies involve a larger group of participants (e.g., 100 to 200 people) and are usually conducted in participants who have the medical condition for which the drug is being studied. These studies are used to identify the dose range of the drug that will be tested in subsequent larger studies (i.e., Phase III studies).
Phase III studies provide additional information about safety and efficacy when the drug is used in the way it is intended to be marketed. These studies are initiated only after earlier studies have demonstrated that there is an acceptable risk to benefit profile (i.e., the risk of taking the drug is outweighed by the potential benefit of the drug to the participant). These large studies are usually conducted at many different study centers; up to 10 to 30 study centers and between 500 and 5,000 participants may be included.. These studies are used to confirm the indication and best dosage for the drug.
Phase IV studies are conducted after the drug is available for sale (i.e., post-marketing studies) and they evaluate how safe and effective the drug is when exposed to the “real” population. These studies evaluate parameters such as different formulations, dosages, treatment durations, and drug interactions. The Food and Drug Administration (FDA) may require a company to conduct certain Phase IV studies as a provision for product approval. These studies may include new age groups, various races and other types of participants. These studies are useful for detecting and defining previously unknown or inadequately quantified adverse events and related risk factors. The size of these studies is broad and can range from less than 100 to over 20,000 participants.
Clinical trials are sponsored by government agencies such as the National Institutes of Health (NIH); pharmaceutical companies; individual physicians or investigators; health care institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment. Clinical trials can take place in a variety of locations, such as hospitals, surgical centers, universities, or doctors’/dentists’ offices.
A Principal Investigator (PI) is a person qualified by education, training, and experience to assume responsibility for the proper conduct of a trial. They are usually, but not always, physicians or oral surgeons. The PI bears ethical responsibility for the study and is the leader of the study team. Final responsibility for the quality control of study procedures and the integrity and scientific merit of study findings rests with the PI.
Study Coordinators, who are often but not always nurses, are the “experts” of the protocol aside from the Principal Investigator. They have a high level of expertise and devote a great deal of time to the planning and conduct of a research project. They will assist you throughout the study during the consenting process, taking the study medication, performing evaluations, and answering any questions you may have. An experienced Study Coordinator is a valuable source of knowledge and guidance for participants.
People choose to take part in clinical trials for many reasons. Usually, they hope for benefits for themselves such as hope for a cure of disease, a longer time to live, an increased quality of life, or a way to decrease or eliminate pain. Some people choose to participate because of the financial compensation they receive. Others may want to contribute to a research effort that may help others.
People who participate in clinical trials are among the first to receive new research treatments before they become widely available. Sometimes these people have the first chance to benefit from a cutting-edge treatment. However, there is no way to know whether an investigational treatment will be effective for a participant. (Even standard treatments, although effective in many participants, do not guarantee benefits for everyone.) Some people in a study may not receive the active treatment and instead will receive a placebo (i.e., a sugar pill). Although all participants in clinical trials are carefully monitored both during and after conclusion of the trial, there are always known and unknown risks associated with new treatments. Participants should decide whether or not to participate in a study only after they understand both the potential risks and benefits.
People who participate in clinical trials are among the first to receive new research treatments before they become widely available. Sometimes these people have the first chance to benefit from a cutting-edge treatment. However, there is no way to know whether an investigational treatment will be effective for a participant. (Even standard treatments, although effective in many participants, do not guarantee benefits for everyone.) Some people in a study may not receive the active treatment and instead will receive a placebo (i.e., a sugar pill). Although all participants in clinical trials are carefully monitored both during and after conclusion of the trial, there are always known and unknown risks associated with new treatments. Participants should decide whether or not to participate in a study only after they understand both the potential risks and benefits.
All clinical trials have criteria that determine who is allowed to participate. You cannot participate in a study if you don’t meet all of the study criteria. These criteria include such factors as age, type of disease, medical history, and current medical condition. Some studies seek volunteers with specific medical conditions and others seek healthy volunteers. It is important to note that these study entry 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 study procedures and process will vary depending on the type of clinical trial you participate in. Before you begin a study, the process and all procedures for that study will be explained to you. Throughout the study, the Study Coordinator and the Principal Investigator will assist you and can answer any questions you have. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.
Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. Your participation will be most successful if you carefully follow all instructions you are given and stay in contact with the research staff.
Most all investigative treatments can cause side effects and other health risks. Side effects and health risks vary from participant to participant. The number of side effects, if any, you experience will depend on the type of treatment being studied and your medical condition. Because clinical trials evaluate new medical treatments, the risks of the treatments are not always known ahead of time. However, in every study several safeguards are put in place to protect the safety of the participants. Before you agree to participate in a study, it is important that you know what side effects may occur and, as much as possible, what unknown side effects or risks may occur. This information will be covered thoroughly during the informed consent process before you enroll in the study.