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What is a clinical trial?

A clinical research study, also called a clinical trial, is a carefully controlled test of an investigational medicine or vaccine to see if it works safely in a group of volunteers. A clinical research study may also involve researching new uses for an already approved medicine.

There are different kinds of clinical trials, including those to study:

• prevention options
• new treatments or new ways to use existing treatments
• new screening and diagnostic techniques
• options for improving the quality of life for people who have serious medical conditions

Before any medicine or vaccine can be prescribed by a doctor and sold at a pharmacy, it must go through careful testing to see if it works and works safely It is the only way a medicine can become approved for use. The testing is done in phases.

What is it called?	Why do they do it?
Phase 1	To test the investigational medicine for safety and how much medicine should be given
Phase 2	To test if the investigational medicine works and if there are any side effects
Phase 3	To test that the investigational medicine works and is safe in a bigger group of people
Review and Approval	To make sure the information collected about the investigational medicine is correct and that it is safe to be prescribed by a doctor and sold at a pharmacy
Phase 4	To collect more information on the medicine if necessary, once it has been approved by a government agency to be prescribed by a doctor and sold at a pharmacy

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Who runs a clinical research study?

Sponsor
A “sponsor” pays for a clinical research study. A sponsor may be a drug company, a private organization or a government agency. These different groups often work together to discover new and better medicines.

Study Doctor and Study Coordinator
To conduct clinical research, sponsors work with health care professionals like CNS Healthcare. The doctor in charge of the study is called the Principal Investigator. The Study Coordinator is a health care professional who coordinates study-related activities. For a list of Principal Investigators or Study Coordinators by location, click here.
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Are trials safe?

Clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. They are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

CNS Healthcare administers their clinical trials according to ethical and legal codes that govern medical practice and strict rules set by the Food and Drug Administration (FDA).

Before accepting patients into their trials, CNS Healthcare conducts a complete health assessment and gives detailed information about what will happen during the trial. This is called an informed consent. Participants sign the “consent" document before joining the study, indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown, risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.
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How do doctors and researchers test whether a medicine works?

Researchers compare an investigational medicine to an already approved medicine or a placebo. Placebo is often referred to as a “sugar pill.” A placebo has no active ingredients, is not made of sugar and its ingredients have no nutritional value.

The comparator (approved medicine or placebo) is made to look exactly like the medicine being tested in the clinical research study. There is no way to tell the difference between the investigational medicine and the comparator. It is very important that the results of the clinical research study are correct. As a volunteer, you will not know what medicine you are receiving (investigational, approved, or placebo) until the study ends.
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Why do researchers use an approved medicine as a comparator?

It is the best way to know how the investigational medicine will work compared to an already approved medicine.
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Will I know which medicine I will get in a clinical research study?

A computer program will randomly place you in a treatment group. “Randomly” means that you will be put in a group by chance. Neither you nor your doctor can choose the group in which you will be placed.
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What are the benefits of participating in a trial?

There are a number of reasons people of all ages, including children, adolescents, adults and the elderly, participate in research studies. Qualified participants in CNS Healthcare’s clinical trials benefit from:

• Treatment with experimental or study medications not widely available elsewhere.
• Care from a research team that includes doctors and other health care professionals who are familiar with the most advanced treatments available.
• Treatment that has been reviewed by many people, including other doctors and researchers.
• A full health assessment and diagnosis with all lab tests and physicals completed in our clinic.
• Research-related care or medicine at no cost. No insurance is needed to participate.
• Complete privacy and confidentiality. Your health insurance plan is never contacted nor used.
• The opportunity to learn more about an illness and how to take care of it.
• The satisfaction of helping others by contributing to medical knowledge, or helping to identify possible new treatments.
• Compensation for their time and travel.
• No overnight stays.
• Free parking.

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What should I expect?

If there is a study that is right for you, the research team at CNS Healthcare will tell you key facts and update you about the clinical research study including:

• Study vistis, tests and procedures
• The risks and benefits
• Your privacy and your rights
• Compensation for qualified study participants

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What will be expected of me?

As a clinical research study volunteer, you will be asked to:

• Go to study visits at one of our health clinics
• Take your study medication as scheduled
• Fill out study-related forms
• Talk with your research team about how you’re feeling

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Your safety is important.

CNS Healthcare takes extra measures in monitoring your well-being. You will have regularly scheduled weekly visits with a doctor and/or nurse practitioner. However, should we deem that you are experiencing an adverse reaction we will immediately stop the current treatment.

If you join a clinical research study, you have the right to:

• Leave the study at any time. Participation is strictly voluntary and you can choose not to participate in any part of the research. However, you should not enroll if you do not plan to complete the study.
• Receive any new information that might affect your decision to be in the study.
• Continue to ask questions and get answers.
• Maintain your privacy. Neither your name nor any other identifying information will appear in any reports based on the study.
• Ask about your treatment assignment once the study is completed, if you participated in a study that randomly assigned you to a treatment group.

There are many rules for conducting a clinical research study to make sure your safety and privacy are protected.

IRB
The Institutional Review Board (IRB), or ethics committee, is a diverse group of healthcare professionals and members of the public that approve clinical research studies for the study doctor. This group makes sure the study is run in a way that protects volunteers. Government rules say this group must approve all clinical research studies before getting volunteers.

Research Team
The research team at CNS Healthcare is here to answer your study questions, to keep an eye on your progress while in the study and to help guide you through the clinical research study. For more information about our research team by location, click here.

Government Agencies
These agencies make sure the medicines, vaccines, and some medical devices are effective and safe. Examples of some government agencies are: The U.S. Food and Drug Administration (FDA), Health Canada and European Medicines Agency.

Privacy
Health information that identifies you and is used in any part of a clinical research study is protected- a study consent form will explain how.

The Sponsor
The clinical research study sponsor carefully watches the progress of the clinical research study.
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Am I reimbursed for travel and my time spent?

Qualified participants receive a nominal monetary compensation for their time and travel. In exchange for the voluntary participation in our research, we provide professional care, investigational medication and close monitoring for each of our patients at no cost and there is no need for health insurance.
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How can I volunteer for a clinical research study?

The goal of clinical research is to find treatments that help people live healthier lives. The success of research depends on volunteers like you. By taking part in a clinical research study, you can help researchers discover new medicines that may benefit you, a family member or a friend. Help us to achieve this goal. Volunteer today!
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