Info For Patients
What do you expect
As a study participant, you play a valuable role in helping to get safe, effective drugs approved for public use. We will explain the steps you need to know precisely and concisely.
- We will notify our qualified patients based on their medical folders in the office or provide the news about the projects on our website and update it.
- If you are interested in the topics you want, you can call us or email us.
- The site staff will make an appointment for you.
- Our team will ask you questions to see whether you are qualified to participate in the study and will tell you some information about it.
- If you are eligible for the trial, you will have an appointment with Principal Investigator and Research Coordinator to evaluate & assess you more, provide the necessary information, and address all your concerns and questions. In the end, they will discuss consent forms that you should sign.
- When you sign all required documents, your enrollment process will be completed. You will receive medical care, treatment, lab test, etc.
- Make follow-up visits to monitor your health and safety carefully.
Who We Are
Dr. Seddigh has visited thousands of patients for over 15 years and provided the best quality primary, regenerative, and integrative medical care. Due to this great backup and the sense of responsibility to improve health and wellness, we established our research lab meeting all safety standards and regulations. We are conducting Phase I – IV clinical trials. We value our volunteers and respect their time and effort. We are committed to creating a safe, comfortable patient environment and conducting trials.
What Are Clinical Trials
Clinical trials are research studies performed to ensure the safety and effectiveness of new medication or treatment. They are performed on people that are aimed at evaluating a medical, surgical, or behavioral intervention. All medicines and medical devices must be tested by the U.S. Food and Drug Administration (FDA) before being made available to the public.
Clinical trials are conducted according to a plan called a protocol. Volunteers who participate in the study must agree to the rules and terms outlined in the protocol. Similarly, researchers, doctors, and other health professionals who manage clinical trials must follow strict regulations set by the FDA. These rules ensure those who agree to participate are treated as safely as possible. Clinical trials are conducted for many reasons:
- To determine whether a new drug or device is safe and effective for people to use.
- To study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease specific side effects.
- To learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a study, you will be given an informed consent document describing your rights as a participant and details about the study, including potential risks. Signing it indicates that you understand that the trial is research. All clinical trials follow by rules of the FDA [U.S. Food & Drug Administration] to provide maximum safety and protect the participants. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.
The research is valuable for gaining new information about new methods and medications. So first, by participating, you can help to find and develop this scientific matter. Second, you will receive financial compensation (if applicable). Third, the participant will evaluate their health condition by physician and medical staff, having the lab tests, diagnostic tests, and treatment at no cost.
Yes, all steps of clinical trials are based on FDA and in compliance with ICH E6.
As the informed consent form (ICF) mentions, participants can leave anytime.