Participation
Process & FAQ
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Participation
Process
GETTING STARTED
Once you fill out a form to be considered for one of Paradigm Clinical Research’s current studies, the following steps will occur:
01
Phone Screen
We will call you to briefly discuss your medical history, medications, and the clinical study details. If you meet the initial study requirements, we will schedule a convenient time for you to visit our office and meet with our clinical study team
02
Office Visit
During your first visit, you will need to fill out a basic registration packet. You will also need to review and sign the study’s Informed Consent document. From there, our team will conduct a series of study-specific exams, procedures, and lab tests.
03
Begin Study
If your results meet the criteria, you will receive an invitation to participate in the study. Each study has different requirements for the number of visits, timeline, and potential compensation. We provide all the information and support throughout the study.
Frequently Asked Questions
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.
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.
Yes, as a volunteer, you have the right to withdraw from a clinical study at any time. However, it is recommended that you speak to your Paradigm Clinical Research team first. Your doctor can inform you of the potential consequences of leaving the study on your health and provide information on alternative treatment options that may be available.
A protocol serves as a study plan for all clinical studies and is carefully designed to protect the health of the participants and answer specific research questions. It outlines the inclusion and exclusion criteria that determine who can participate in the study, as well as the schedule of tests, procedures, medications, dosages, and the duration of the study. Participants in a clinical study are regularly monitored by the Paradigm Clinical Research team according to the protocol to assess their health and evaluate the safety and effectiveness of the study treatment
A placebo is an inactive pill, liquid, or powder that has no therapeutic value. In clinical studies, experimental treatments are often compared to placebos to evaluate the treatment’s effectiveness. In some studies, the control group participants receive a placebo instead of an active drug or treatment.
Clinical studies are conducted in different phases, each serving a unique purpose and helping researchers answer specific questions:
- Phase I studies involve testing a new drug or treatment on a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify any side effects.
- Phase II studies involve giving the study drug or treatment to a larger group of people (100-300) to assess its effectiveness and further evaluate its safety.
- Phase III studies involve administering the study drug or treatment to large groups of people (1,000-20,000) to confirm its effectiveness, monitor any side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV studies, also known as post-marketing studies, provide additional information regarding the drug’s risks, benefits, and optimal use.
When participating in a clinical study, you will typically only be involved in one phase of the study. Treatments progress through the phases, but study participants do not.
An Institutional Review Board (IRB) is a committee composed of both medical and non-medical members who review and consider all clinical protocols involving human study participants. People cannot be involved in research until an appropriate IRB has reviewed and approved the research protocol and informed consent. The IRB assesses various aspects of a proposed clinical research study, such as the risks to the study participants, anticipated benefits to the participants and others, and the importance of the knowledge that may be obtained from the study.
It’s important to be well-informed about the clinical study before deciding to participate. Here are some questions to ask before participating in a study:
- What is the purpose of the study?
- Has the treatment being tested been tried before? Why do researchers think it might be effective?
- Will the study involve a placebo or a medication already on the market?
- How long will the study last, and what will be required of me as a participant?
- Will I receive any compensation, and can I still see my own doctor for general health care issues?
- Will there be any follow-up care after the study?
As a research participant, you have the right to:
- Know that you are participating in a clinical study.
- Understand the purpose and duration of the study.
- Be informed about the risks and potential side effects.
- Have your personal information kept confidential.
- Withdraw from the study at any time
Clinical studies are necessary to determine the safety and effectiveness of new treatments and procedures. By participating in a clinical study, you contribute to the advancement of medical knowledge and the development of new treatment options that can improve health outcomes and save lives. Without the participation of volunteers in clinical research, there would be no new medications or groundbreaking advances in health care. Clinical research involves rigorous testing, but it offers the potential for new ways to diagnose, prevent, and treat diseases and disabilities. By taking part in a clinical study, you can play a vital role in helping researchers find the answers that will lead to improved health care options for everyone.
As a participant in a clinical study, you have the following rights:
- To be informed that you are participating in a clinical study.
- To be informed about the purpose of the clinical study.
- To be informed about what will happen during the study, including what you will be asked to do and how long it will last.
- To be informed about possible risks, side effects, and discomforts, including those that are not yet known.
- To understand how your personal information will be kept confidential.
- To withdraw from the study at any time.
- To participate in an informed consent discussion, where the research team will explain the study and give you time to make an informed decision.
- To receive a copy of your consent form.
Yes, in a clinical study, the participant continues to work with their primary healthcare provider. However, most clinical studies only provide short-term treatments for a designated illness or condition, and they do not offer extended or complete primary health care. Also, by involving the participant’s health care provider in collaboration with Paradigm Clinical Research, any potential conflicts with other medications or treatments can be avoided.
