CLINICAL STUDIES

Clinical research evaluates the effects of new treatments, tests, or devices on human health. Clinical research is done by conducting clinical studies. Two main types of clinical studies are interventional studies and observational studies.  We do clinical studies because they are needed to assess safety and benefits of new treatments, tests, or devices.

In interventional clinical studies, participants receive a specific intervention according to the research plan (or protocol) developed by the medical scientists (clinical researchers) running the study. An intervention could be a different type or dose of medication, a new treatment schedule, or a medical procedure. This type of clinical study is often designed to determine whether the new intervention is helpful, harmful or no different than the intervention(s) that are currently available for that condition.

In observational studies, clinical researchers collect information about the participants to assess health outcomes without assigning the participants to a specific intervention.  Participants may receive medical care (e.g., drugs, tests, procedures) while participating in the study, but they will not receive an experimental intervention. However, participants in an observational study may be asked to answer questions, report on specific issues, or contribute additional biological samples, such as blood, saliva, or tissue.

Exact Sciences conducts both observational and interventional clinical studies, depending on the scientific or research question that needs to be answered. Study staff at the research site will inform participants which type of trial they are conducting when they first discuss the study. 

Anyone can participate in a clinical study as long as they meet the qualifications (“eligibility criteria”) for that study.  For example, some studies require that participants have a specific disease or health condition to participate.  Other factors that are often considered for eligibility are age, other medical conditions and whether or not a participant has previously been treated for the disease or condition being studied.

If you are interested in participating in a clinical study, your doctor or study staff can help you determine if you meet the qualifications.

Before participating in a clinical study, interested individuals must be informed about the potential risks, benefits and alternatives to the proposed study and, when required, provide written consent to participate.  This process is called informed consent.

There is a formal process for guiding individuals through the informed consent process. Study staff will review the study information with the interested individual, including an informed consent form, which must be read by the individual and signed by them or their legally authorized representative in order to participate in the study.  In addition, the informed consent process often includes written materials about the study, verbal instructions, question-and-answer sessions and/or activities to ensure that the potential participant understands the information. The goal is to make sure that every person participating in a study understands the commitment they are making. 

An Institutional Review Board (IRB) is a group of doctors, scientists, patient advocates, and community members, tasked with reviewing and approving clinical study protocols and related materials (e.g., requirements for informed consent, informed consent documents and other study related materials). Studies involving human participants must be reviewed by an IRB before they can begin and are monitored throughout the duration of the study. The IRB process ensures protection of the rights and welfare of clinical study participants. The IRB makes sure that studies are well designed, ethical, legal and safe. 

Yes. Participating in a clinical study is voluntary and you can end your participation in the study at any time for any reason.

Diversity is important to a study because biological, social, and economic factors can affect how people respond to a drug, device, or other intervention.  To make sure that a scientific finding applies to everyone, studies should represent the broad community, including a wide range of ages, genders, races, ethnicities, insurance statuses, and other considerations.

At Exact Sciences, we are dedicated to increasing diversity in our clinical studies by addressing barriers to equity in healthcare, educating research providers and the public about the importance of diversity in clinical research, and including patient feedback into study design and planning.   

ClinicalTrials.gov: A database of publicly and privately funded clinical studies conducted around the world.

https://www.fda.gov/patients/clinical-trials-what-patients-need-know