Clinical studies are research studies in which new therapies and treatments are tested in patients to determine if they are safe and effective. By participating in clinical trials, patients can contribute to medical research while helping to improve treatments and care for others.
Clinical studies are necessary because they provide a means to develop new treatments that can be safer or more effective than currently available drugs. They also enable researchers to discover new uses for drugs already on the market. Furthermore, they make it possible to develop new treatments when no other treatment is available.
All clinical studies have guidelines limiting participation to ensure they are studying the appropriate patient population and that it is safe for them to participate. Guidelines can include age, gender, the type and stage of a disease, previous treatment history and medical conditions. Clinical studies may want participants with certain illnesses or conditions to be studied, while other studies may need healthy participants.
Participation in a clinical study is completely voluntary. Before joining a study, a volunteer will receive an informed consent form, which provides detailed information about the study treatment, the required visits to the physician, and any procedures that may be done during the visits. These study visits are pre-scheduled according to the study protocol, or a written set of rules that guide the conduct of the study. Study participants have the right to withdraw their consent at any time during the study. During a clinical study, a patient is provided with any new information that may affect his/her decision to continue participation in the study.
Study protocols, informed consent forms, and the progress of clinical studies are reviewed, approved, and monitored by the the Food and Drug Administration (FDA), UCI Institutional Review Board (IRB), and the physicians conducting the clinical study. The primary goals of the IRB are to protect the public, to determine whether the possible benefits of participating in the study outweigh the risks and to ensure that patients are not pressured into participating in clinical studies.
Researchers are searching for new information and new answers to health problems faced by people in your community and around the world. Because of this, most research is not intended to provide you with direct benefits, though it can help lead us to generalized knowledge to better inform our health care professionals on evidence-based treatment options for you and the community at large. When you participate in research, you are contributing to scientific progress and helping society by unlocking the door to potential breakthroughs, discoveries, and even a cure. Although being in a medical study might help you, nobody can guarantee a direct benefit for you.
Research can have serious risks and is not the same as treatment. Many of the drugs, devices, and procedures being tested are experimental. This means that they have not been proven to work and there may be unknown risks.
Payment will be explained to you during the informed consent process. Some studies do not have the resources to pay you. Other studies might pay you for the time and effort it takes to participate. The money is usually only enough to cover expenses (parking, transportation, meals, etc.) and some compensation may be given for the time you spend away from work. The payment should not be enough to convince you to take risks that you normally would not take. If you leave before the end of the research, you will usually be paid for that portion of the research study you complete.
If you are participating on a paid study, please review our Frequently Asked Questions to further learn about Subject Research Compensation and Reimbursement. As well as to learn more about our Onboarding Instructions to facilitate receiving payments in a timely manner.