At the UCI Center for Clinical Research (CCR), we prioritize the full patient experience and recognize that privacy, security, and safety are at the forefront of that. Below are the typical steps that occur when participating in one of our studies.
The patient experience starts with a pre-screening process, during which our experienced study team will ask you some basic questions to determine if you meet the preliminary qualifications for a particular study.
If you pass the preliminary review, you will proceed to the informed consent process. During this process, members of the study team will provide you with detailed information about the study, and you will have the opportunity to ask questions and ensure you fully understand the study's goals, procedures, and potential risks. We will provide you with a consent form and any other relevant study documents, such as a form giving permission to use your medical records.Please note that at UCI, your privacy, security, and safety are always our top priority.
Once the consent form is signed, you will enter the screening process, where researchers may need to gather additional information to confirm your eligibility. This may include a physical examination, blood tests, or other procedures, which will be fully described in the consent form you signed.
If you qualify for the study, you will enter the enrollment or research phase. This may involve receiving an experimental or investigational treatment, as outlined in the consent form. The duration and frequency of visits will depend on the study's goals and requirements, and we will ensure you fully understand the logistics before enrolling.Sometimes researchers will be able to work around your schedule. In other studies, visits may need to happen at very specific times.
Some studies may have an optional “extension” or “open-label” study that extends the duration of a previous clinical trial.It involves following up with participants who have completed the original trial and continuing to study the effects of the treatment over an extended period of time. These trials are typically used to evaluate the long-term safety and efficacy of a treatment, especially for chronic conditions or diseases that require ongoing management.An important aspect of extension clinical trials is that they offer participants the opportunity to either continue receiving the treatment or try it if they were initially in the placebo group during the primary study. This can be especially valuable for participants who have experienced positive results from the treatment and wish to continue it, or for those who were not initially given the treatment but now can receive it.
A follow-up period is where participants are asked to return after they are off study treatment to provideadditional information or data to the research team. The follow-up period can occur at various intervals, ranging from weeks to years after the initial treatment or intervention.During the visit(s), the research team may perform physical examinations, collect blood samples, or other tests to monitor the participant's response to the treatment and assess any potential side effects or complications
Common Procedures
Clinical trials can involve various procedures, depending on the specific study's design, goals, and treatment being tested and will be clearly outlined in your informed consent form. However, here are some common procedures that may be part of clinical trials:
Physical examinations
Blood tests
Urine tests
Imaging studies (E.g., X-rays, CT scans, or MRIs)
Electrocardiograms (ECGs) to measure heart function
Biopsies to obtain tissue samples for analysis
Medical history and health status questionnaires
Vital sign measurements (E.g., blood pressure and heart rate)
Drug administration (E.g., pills, injections, or infusions)
Dietary assessments or interventions
Monitoring of symptoms or side effects
Quality of life assessments or surveys
Cognitive or psychological tests
These procedures help researchers gather data about the treatment's safety, efficacy, and potential side effects, as well as the participants' overall health status and quality of life.
Diversity in Clinical Trials
Diversity in clinical trials is critical to advancing medical knowledge and ensuring equitable access to new treatments. Including a broad range of participants from diverse backgrounds can help identify potential differences in the safety and efficacy of new treatments across different populations. It can also help address health disparities and ensure that medical treatments are effective for everyone, regardless of their race, ethnicity, gender, age, or other demographic factors.
Different populations can have different genetic makeup, lifestyles, and health risks, which can affect how they respond to medical treatments. By including a diverse range of participants in clinical trials, researchers can better understand how a new drug or treatment may work in different populations.
Clinical research that lacks diversity can result in limited generalizability of results. If a study includes only a small, homogeneous group of participants, the findings may not be applicable to a larger and more diverse population. Inadequate representation of underrepresented groups can perpetuate health disparities and lead to less effective and less safe medical treatments.
There is an ethical imperative to ensure that clinical research is conducted in a fair and just manner. This means that all individuals should have equal access to participate in clinical trials and the benefits that may result from them, regardless of their race, ethnicity, gender, age, or other demographic factors.
At UCI CCR, we are committed to promoting diversity in our clinical trials by actively recruiting and engaging participants from underrepresented communities. Our goal is to ensure that all individuals can participate in cutting-edge research and contribute to the development of new medical treatments. If you are interested in participating in a clinical trial, we welcome individuals from all backgrounds and encourage you to learn more about our current studies.
