Clinical trials help researchers evaluate potential new medications, treatments, and medical devices before they become widely available. Every study follows strict safety guidelines and is led by experienced healthcare professionals.

Each study has specific requirements, including:

• Who can participate
• What visits or procedures are involved
• How long participation lasts
• What information researchers will collect

By participating in clinical research, you can help advance healthcare and contribute to future medical discoveries.

Investigational products such as medications, devices or procedures are conducted in various clinical trial phases to find different kinds of information.

Phase 1 Studies

Phase 1 studies include a small number (20-80) participants, usually healthy volunteers, in some cases patients with advanced disease (e.g. cancer, mental health disorders) and is often the first time tested in humans. The purpose of Phase 1 studies is to:

• evaluate safety
• identify side effects
• determine a safe dose range
• learn how the investigational product is absorbed and handled by the body (pharmacokentics/dynamics)

Phase 1 studies generally take several months to complete. Approximately 70% of Phase 1 studies continue to Phase 2.

Phase 2 Studies

Phase 2 studies enroll more people than Phase 1 studies (100-300 participants) with the condition under study. In Phase 2 studies researchers further evaluate safety and determine if the investigational product has the intended effect in humans. These studies are sometimes randomized controlled trials where one group of patients receives the investigational product, while another group (the “control group”) receives a standard treatment or placebo. In order to provide unbiased comparative information, these study are often “blinded” which means neither the patients nor the researchers know who is receiving the investigational product.

Phase 2 studies usually take up to two (2) years to complete. About 33% of Phase 2 conducted successfully move on to Phase 3.

Phase 3 Studies

In Phase 3 larger numbers (thousands) of patients with the disease are included to:

• confirm or further evaluate an agent’s effectiveness
• monitor side effects
• compare it to commonly used treatments
• collect other information that will be used to determine whether the agent should be approved and marketed

These trials are usually randomized and blinded trials that generally takes up to several years (1-4 years) to complete. 25 to 30% of Phase 3 studies are successfully completed and are submitted to the FDA by the pharmaceutical company for approval to market the investigational product in the United States.

Participating in a clinical trial gives you the opportunity to contribute to the future of healthcare while learning more about your own health. Depending on the study, you may have access to investigational treatments and study-related care at no cost.

Benefits of participating may include:

• Access to investigational treatments
• Study-related care at no cost
• Compensation for study-related time and travel (in some studies)
• Helping advance medical research for future generations
• The freedom to stop participating at any time

Each study has specific eligibility requirements, so not everyone who applies will qualify. Our team will guide you through the screening process and answer any questions along the way.

There are many different types of clinical research studies, including:

• Prevention studies that look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Studies that test new treatments, new combinations of drugs, or new approaches for therapy.
• Diagnostic studies are conducted to find better tests or procedures for diagnosing a particular disease or condition. Screening studies test the best way to detect certain diseases or health conditions.
• Quality of Life studies (or Supportive Care studies) explore and measure ways to improve comfort and the quality of life for individuals with a chronic illness.

Usually, clinical trials compare a new product or therapy to something else to see if it works as well or better to treat or prevent a disease or condition. In a blinded study, a participant may be randomly assigned to receive the test product, or an existing, approved therapy.

In some studies, participants may be assigned to receive a placebo (a product with no therapeutic action that looks or acts like the test product). Comparison with a placebo can be the fastest and surest way to demonstrate therapeutic effectiveness of new products.

Potential participants are told before they enter a trial whether placebos are going to be used in the study and the risks and benefits of the study medication(s).

A clinical research study is conducted according to a research plan known as a study protocol which is designed to answer specific research questions and to assure the safety of the participants. The protocol includes the following information:

• The reason for conducting the study
• Who may participate in the study (inclusion/exclusion criteria)
• The number participants needed
• The schedule of tests, procedures, investigational product and their dosages
• The length of the study
• What information will be collected about the participants.

The following process generally occurs during the conduct of a clinical research study:

Pre-Screening

The clinical research group will review their existing patient databases or medical charts to identify potential patients who may be eligible to participate in the clinical research study. They may also place advertisements on the internet, newspaper, radio, or television to recruit interested participants. They may also conduct seminars, free health screenings, or forums.

Potential participants from these pre-screening efforts are contacted and briefly interviewed to confirm if they are potentially eligible to participate in the clinical research study.

Informed Consent

If you are potentially eligible to participate in a clinical research study, an appointment will be scheduled for you to come to the clinical research site and meet with one of the research staff members. Before any study related procedures are performed you will be required to sign an informed consent form which details the study design, risks and benefits, your rights as a study participant and who to contact in case of an emergency. During the informed consent process, you will have an opportunity to ask questions you may have regarding the study and your participation. You should receive a copy of the signed informed consent form for your records and future reference.

Screening Visit

Once you agree to participate in the clinical research study and have signed the informed consent form, the study screening procedures will be administered. The purpose of the screening visit is to determine if you meet the specific inclusion and exclusion criteria for the specific clinical research study you agreed to participate in. Generally, during the screening visit you may be asked to answer questions regarding your medical history, medications and other treatments you are taking, and complete questionnaires. A member of the research team may also assess your general health by performing a physical examination, EKG and collect blood/urine samples.

Generally, the investigational product is not dispensed during the screening visit.

Study Visits (Treatment Visits)

If you meet the specific inclusion and exclusion criteria (which includes a study acceptable laboratory and medical results) for the study you will be asked to return to the clinic for a series of study visits sometimes referred to as Treatment Visits. It is generally during these study visits that a study participant will be receive the investigational product or the comparator product (which sometimes can be a placebo). The number of study visits and the interval in which the visits occur varies from study to study.

End of Study Visit

Once you have reached the end of the treatment visit, an End of Study Visit is conducted. Generally, the same or similar assessments conducted prior to you receiving the investigational product is repeated. The research team will also discuss you follow-up treatment options (which may include receive standard of care treatments for your illness) and if required by the study you may be asked to return to the research site for a follow-up safety visit.

Follow-up Safety Visit

The number of follow-up safety visits and the interval in which the visits occur varies from study to study. The purpose of this visit is to assure you are not experiencing any lingering side-effects from the investigational product or from the overall participation in the study.

Before you decide to join a clinical research study, you’ll receive detailed information about what participation involves. This process, called informed consent, is designed to help you make an informed decision and ask questions along the way.

• The consent form explains:
• The purpose of the study
• What visits, tests, or procedures are involved
• Possible risks and benefits
• How long the study will last
• Your rights as a participant

You’ll have time to review the information, discuss it with family, friends, or your healthcare provider, and ask as many questions as you’d like.

Participation is always voluntary. You may choose not to join or leave a study at any time, for any reason.

Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:

• What is the study trying to find out?
• What kinds of test and exams will I have to take while I’m in the study? How much time do these take? What is involved in each test?
• How often does the study require me to go to the doctor or clinic?
• Will I be hospitalized? If so, how often and for how long?
• What are the costs to me? Will my health insurance pay for it?
• What follow-up will there be?
• What will happen at the end of the study?
• What are my other treatment choices? How do they compare with the treatment being studied?
• What side effects can I expect from the treatment being tested? How do they compare with side effects of standard treatment?
• How long will the study last?

All clinical research studies involve some level of risk, just as medical treatments and everyday activities do. The possible risks and side effects of a study are explained to you before you decide whether to participate.

Our research team will review the study details, answer your questions, and help you understand the potential risks and benefits so you can make an informed decision.

While participation may or may not provide a direct benefit to you, every volunteer helps advance medical knowledge and contributes to the development of future treatments

Each clinical research study has specific eligibility requirements based on factors such as age, medical history, current health, and other study-related criteria.

Some studies are designed for people with certain medical conditions, while others are open to healthy volunteers. Our team will guide you through a screening process to determine whether a study may be a good fit for you.

Because every study is different, not everyone who applies will qualify for participation.

Every clinical research study is led by a Principal Investigator who is often a licensed medical doctor, and a clinical research team that may include doctors, nurses, social workers, and other health care professionals. In general, the clinical research team roles and responsibilities will include:

Principal Investigator (PI): 

A person responsible for the ethical conduct of the research study. This includes protecting human subjects’ rights, safety and welfare, protocol (study) compliance, and adherence to institutional, state and federal regulations and guidance. The PI is responsible for ensuring informed consent is appropriately obtained from each participant and for appropriately maintaining study records. The PI is also responsible for complying with the financial and administrative policies and regulations associated with the award, overall fiscal management of the project, and conflict of interest disclosure.The PI oversees all aspects of a clinical trial from protocol design, recruitment, data collection, analysis and interpretation of results, but some tasks can be delegated to other research team members (Co-Investigators and Key Personnel). The PI is responsible for ensuring that all research team members have appropriate education, training and qualifications to assume delegated study tests. All study team members are responsible for ensuring that the conduct of the study is compliant with institutional, state, federal and industry guidance and regulations.

Sub-Investigator:

The Sub-Investigator may perform all or some of the PI functions, but they do not accept primary responsibility for the research study. The sub-investigator is under the supervision of the PI and is responsible for performing study–related procedures and /or to make important study-related decisions in compliance with the ethical conduct of the study.

Research Coordinator: 

The Research Coordinator oversees and coordinates the daily activities of clinical research studies. They work closely with the clinical teams and investigators to ensure that all protocol required procedures and visits occur according to protocol specified guidelines. Research Coordinators generally manage participant enrollment and ensure compliance with the protocol and other applicable regulations. This includes but is not limited to: participant recruitment, obtaining informed consent, educating participants on the details of the research study, assessing participant eligibility, facilitating participant care and follow-up per protocol, creating source documentation, assisting in the assessment of toxicities/adverse events and reporting serious adverse events per IRB and sponsor requirements. They are generally the primary contact person for the research subject.

Protecting your personal information is a priority. Any information you share with our research team is handled with care and kept confidential in accordance with applicable privacy laws and regulations.

If you choose to contact us or submit your information, with your permission we may use it to determine your eligibility for current and future research opportunities. Participation is always voluntary, and you may request to update or remove your information from our database at any time.

Our team is committed to safeguarding your information while connecting you with research opportunities that may be right for you.

In most clinical research studies all visits, tests, and procedures related to the study are free of charge. If you qualify for one of our research studies, you may be compensated for your time and travel. The amount of compensation (as well as any expenses not covered by the study) will be reviewed during the informed consent process.

Every clinical research study is different, so the number of visits and length of participation can vary. Most study visits last about 30 minutes to a few hours, depending on the study requirements.

Your first visit, called a screening visit, is typically the longest. During this visit, you’ll review the study details, ask questions, complete required assessments, and learn what to expect if you choose to participate.

Before joining a study, our team will clearly explain the visit schedule, study timeline, and any study-related procedures.