Clinical Research:
East Bay Rheumatology Medical Group conducts cutting-edge research in Rheumatoid Arthritis, Lupus, Osteoarthritis other Rheumatic and Auto Immune diseases. We work with leading Pharmaceutical Companies and all studies are regulated by the FDA and follow strict legal and ethical codes to protect the interests and welfare of patients. Our goal is to find new and improved medications and treatments that help you with your disease and provide help for others in the future.
Contact our Research Department to learn about our current trials: 510-357-1040.
Gout Trials
Gout is a type of inflammatory arthritis caused by the accumulation of urate crystals in the joints, resulting in severe pain, swelling, and inflammation. This study aims to assess the potential of new therapies in managing gout symptoms and improving patient outcomes.
Lupus Trials (SLE)
Lupus is a chronic autoimmune disease that can affect multiple organs and systems in the body. This study aims to assess the potential of new treatments in managing lupus symptoms and improving patient outcomes.
Osteoarthritis Trials
Osteoarthritis (OA), or "wear-and-tear" arthritis, is a degenerative joint disease where the cartilage that cushions the ends of bones gradually wears away, leading to pain, stiffness, and reduced mobility, most commonly affecting the hands, knees, hips, and spine. This study aims to assess the potential of new treatments in managing osteoarthritis symptoms and improving patient outcomes.
Psoriatic Arthritis Trial
Psoriatic arthritis is a chronic inflammatory condition that affects the joints, causing pain, swelling, and stiffness. This study aims to evaluate the potential of new therapies in managing PsA symptoms and improving patient outcomes.
Rheumatoid Arthritis Trial
Rheumatoid arthritis is a chronic autoimmune disease characterized by joint inflammation, pain, and stiffness. This study aims to evaluate the potential of a new therapy in managing the symptoms and improving the quality of life for RA patients.
Rheumatoid Arthritis Observational Studies
We are conducting an observational study to collect lab samples of patients diagnosed with Rheumatoid Arthritis.
Scleroderma or Systemic Sclerosis
Scleroderma, also known as systemic sclerosis is a chronic autoimmune disease that causes thickening and hardening of the skin and connective tissues. . This study aims to evaluate the potential of a new therapy in managing the symptoms and improving the quality of life for Scleroderma patients.
Sjogren’s Syndrome
Sjögren's syndrome is a chronic autoimmune disorder characterized by dry eyes, dry mouth, and systemic manifestations. This study aims to evaluate the potential of new treatments in managing SS symptoms and improving the quality of life for affected individuals.
Clinical research is the study of health and illness in humans. It aims to improve our understanding of diseases, develop new diagnostic methods, and create better treatments or medical devices for improved patient care.
Clinical research trials are carefully designed, reviewed, and approved before they can begin. The National Institutes of Health and the U.S. Food and Drug Administration monitor these trials closely to ensure safety and effectiveness. A clinical center’s research studies may directly benefit patients with promising new treatments.
In summary, clinical research is a vital process that helps improve medical knowledge, requires competent conduct with participant protection, follows regulatory and legal/ethical requirements, and ensures informed consent.
All clinical research must meet the following criteria:
- Aims to advance our understanding of health and disease to benefit patients and society.
- Be conducted by qualified and competent individuals who take all necessary measures to protect the well-being of the participants.
- Must obtain all required regulatory approvals and follow all necessary legal and ethical steps to ensure compliance with applicable laws and regulations.
- Must obtain informed consent from all individuals who participate in the study, ensuring that they understand the research's purpose, risks, and benefits and voluntarily choose to participate.
Clinical trials play a vital role in discovering new medicines and treatments for diseases, and there are several compelling reasons why people choose to volunteer. When you volunteer:
- You’re contributing to medical advancements, and you have the opportunity to help the development of new treatments, devices, or preventions for specific diseases or medical conditions.
- You may gain access to investigational treatments before they are available to the general public, offering a chance to receive cutting-edge therapies that may not yet be accessible through other avenues.
- You participate in free diagnostic procedures or medical tests related to the trial at no cost, which can be beneficial for monitoring health and receiving valuable medical services.
- You receive compensation for the time and travel expenses associated with participation, which can help offset any inconvenience or costs incurred during the trial.
On many occasions, we work with medications that are already FDA-approved, and in particular study designs, there are no placebos. In these cases, every patient enrolled gets the active study drug.
Some research studies may seek participants with specific illnesses or conditions, while others may need healthy participants. It's important to note that these criteria are not used to reject individuals personally. Instead, they are used to identify appropriate participants with consideration for their safety and the study's objectives. The study coordinators can answer any questions about the trial and provide further information about the criteria and eligibility requirements.
Participation in a clinical trial is voluntary, and you are under no obligation to participate if you do not wish to do so.
Before you decide to participate in the trial, the research team will provide you with information to help you make an informed decision. You will have opportunities to ask questions before, during, and after the trial. If you choose to participate, you are required to provide your official consent by signing the informed consent document. It's important to note that even after signing the informed consent, you have the right to leave the trial at any time and discuss other treatment options with the medical staff.
The safety and well-being of clinical trial participants are paramount for us and are ensured through various measures, including:
- Independent Ethical Review: All clinical trials conducted in the United States must be reviewed and approved by an independent ethical review committee known as the Institutional Review Board (IRB). The IRB is composed of individuals from various professions, such as doctors, teachers, and religious leaders, who have no affiliation with any pharmaceutical companies. The IRB evaluates all aspects of the research trial to ensure that it follows the guidelines and procedures required to protect the safety and well-being of participants.
- Informed Consent: Participants in a clinical trial are provided with an informed consent document that provides detailed information about the trial, including its purpose, procedures, potential risks and benefits, and their rights as participants. Participants are required to provide their official consent by signing the informed consent document after being fully informed about the trial.
- Ongoing Monitoring: Clinical trials are continuously monitored by the research team and the IRB throughout the trial to ensure that the trial is being conducted in compliance with the approved protocol and regulations. Any concerns or adverse events reported by participants are promptly addressed by the research team.
- Safety Measures: Clinical trials have strict protocols in place to ensure the safety of participants. This may include regular medical assessments, monitoring of adverse events, and adjustments to the trial protocol as needed to protect participant safety.
- Regulations and Guidelines: Clinical trials must adhere to strict regulations and guidelines set forth by regulatory agencies, such as the Food and Drug Administration (FDA), to ensure the protection of participant rights, safety, and welfare.
Overall, clinical trial participants are protected through rigorous ethical and regulatory oversight to ensure their safety and well-being throughout the trial process.
Thoroughly review the informed consent document, ask questions, and discuss with your healthcare provider and trusted individuals. Make sure you meet the trial's requirements and are willing and able to commit to the time and effort required for participation. Consider the potential risks and benefits carefully, and ensure that participation aligns with your health needs and personal circumstances.
In some trials, participants may be randomly assigned to a "control group" that receives either no treatment or a standard treatment already available in the market, while other participants may be assigned to a "treatment group" that receives the investigational treatment being studied.
Randomization helps to eliminate potential bias and ensures that the results of the trial are valid and reliable. The study staff will provide you with more information about the different groups and treatments being investigated in your specific trial.
The clinical trial sponsor is responsible for providing medical treatment for any injuries or complications that occur during the trial. They may also have insurance coverage that can help pay for any medical expenses related to the injury.
It's important to understand that clinical trials are designed to minimize risks to participants, and study staff will do everything possible to ensure your safety. However, all medical procedures and treatments come with some level of risk, and injuries can occur, even in the best circumstances. If an injury happens during the study, the sponsor may be required to provide compensation or other benefits to the injured participant.
Depending on the trial design, if you are assigned to a placebo study, you may take it for a few weeks or for the entire duration of the study. These designs are created by pharmaceutical companies, and reviewed and approved by the FDA. Placebo studies are an integral part of clinical research as it allows scientists to assess whether the medication actually works or not.
If you are considering participating in a clinical trial, it’s important to understand what placebos are and how they’re used. This knowledge will help you make an informed decision about whether or not to participate and which trial is best for you.