Participation Process & FAQ

Clinical research is the study of potential medical treatment options for diseases impacting people all over the world. Such studies are carried out with volunteers who participate in research. People like you can volunteer to be part of these studies. By doing this, you help us learn and make medicine better for everyone.

A clinical study is a special kind of medical research study. It helps us find answers to important questions about new treatments or new ways of using treatments we already know about. We might also study how to prevent diseases that have caused a lot of sickness and death in the past, like viruses. By doing this, we hope to improve people's health.

Clinical studies help us find out if a new medicine or treatment is safe and works well. We want to know if it can prevent a certain disease or make the treatment of a disease better. This process can take a long time. It might take many years to finish some clinical studies.

Clinical studies aim to answer important questions about new treatments. These questions might include:

• Can we find a better treatment for a certain disease?
• Can we prevent a disease more effectively?
• Can we create a treatment with fewer side effects?
• Can we make people live longer with a new treatment?
• Can we prevent disabilities caused by diseases?

To answer these questions, scientists start by developing a new treatment in a laboratory. They might test it on animals humanely to see if it works and is safe. If the treatment looks promising, they move on to a clinical study with human volunteers. At first, the study will be very small and only involve healthy people who are closely monitored. If the treatment proves to be safe, the study will move on to include more people, maybe around 100-500. Finally, if the treatment continues to look good, it will be tested on even more people, sometimes thousands of them.

When you join a clinical research study, you and the Paradigm Clinical Research team will follow a specific plan called the "Study Protocol." It's important to know that a clinical study is designed to answer a question, so you may or may not experience direct benefits from participating. However, your participation can make a significant impact on the study's results and potentially improve the lives of many people around the world. Make sure to talk about this with your doctor or the Paradigm Clinical Research team.

Clinical studies are supported by various organizations or individuals, including doctors, medical institutions, foundations, non-profit groups, pharmaceutical companies, and government agencies like the National Institutes of Health (NIH), Department of Defense (DOD), and Department of Veteran's Affairs (VA). These studies can be held in different settings, such as specialized research facilities like Paradigm Clinical Research Center, hospitals, and universities.

In treatment studies, new medications, drug combinations, or treatment methods are tested for different types of diseases.

Prevention studies aim to find better ways to prevent diseases in people who have never had the disease before, or to prevent it from coming back. This may include the use of vaccines or other medications.

Diagnostic studies focus on developing better tests or procedures for diagnosing a specific disease or condition.

Screening studies investigate the most effective way to detect certain health conditions or diseases.

Quality of life studies (also called supportive care studies) explore ways to enhance comfort and the overall quality of life for individuals living with a chronic illness.

It's important to test new medications on the people they're meant to help. Research also needs to be done on different kinds of people because everyone's body can react differently to treatments. Some people take part in clinical studies when other treatments haven't worked for them, or the side effects were too much to handle. Studies offer another option when other treatments have failed.

Others participate in studies to help medical research and make new medications available for future generations. They understand that every medication available has gone through a careful research process. However, not everyone who applies for a clinical study will be accepted. Volunteers may not meet the eligibility criteria, or the study may already have enough participants.

Informed consent is a crucial process in which potential participants in a clinical study are provided with key information about the study before deciding to participate. The process continues throughout the study to keep participants informed. Doctors and nurses involved in the study explain the details of the study to help the participant make an informed decision. If the participant does not speak English, translation services can be provided. The research team provides an informed consent document that includes information about the study's purpose, duration, procedures required, and important contacts. Risks and potential benefits of the study are also explained in the document. The participant has the option to sign the document after considering all the information provided. It is important to note that informed consent is not a contract, and the participant has the right to withdraw from the study at any time.

The clinical study team is typically composed of doctors and research coordinators who are responsible for various tasks. At the beginning of the study, they assess the participant's health and provide specific instructions for participating in the study. During the study, they closely monitor the participant's condition and response to the treatment or intervention being tested. After the study is completed, they may continue to stay in touch with the participant according to the protocol for the study.

It is important to note that some clinical studies may require more tests and doctor visits than what is typical for an illness or condition. To ensure the success of the study, it is crucial to follow the protocol carefully and maintain frequent contact with the research staff according to the schedule of contacts.

Well-designed and executed clinical studies offer eligible participants various benefits, such as:

• Playing an active role in their health care.
• Possibly being among the first to benefit if the new treatment works.
• Contributing to medical knowledge and helping others.
• Access to expert medical care from specialists in the disease area being studied.
• Possible financial benefits, such as the study sponsor paying for medical care or tests.

However, it is important to keep in mind that participating in a clinical study also involves risks, such as potential side effects from the treatment being tested and the possibility of receiving a placebo instead of the active treatment. Participants should thoroughly discuss the potential benefits and risks with their doctor and the clinical study team before deciding to participate.

The ethical and legal standards that apply to medical practice also govern clinical studies. Furthermore, most clinical research is federally regulated with built-in safeguards to protect participants. The study adheres to a carefully controlled protocol or study plan, which outlines what researchers will do in the study. As the study progresses, researchers report the results to scientific meetings, medical journals, and various government agencies. The names of individual participants are never disclosed.