CLINICAL STUDIES

The two main types that Exact Sciences conducts are interventional studies and observational studies.

Interventional Clinical Studies
In an interventional clinical study, participants receive a specific intervention, which could be:

• a unique medication,
• a new treatment schedule,
• a test, or
• a medical procedure.

The intervention is then compared to the current standard of care for that condition.

This type of clinical study is often designed to determine whether the new intervention is more effective or no different than the standard of care.

Observational Studies
In observational studies, clinical researchers observe and collect information about the participants to measure health outcomes.

Participants are not assigned to a specific intervention or compared to a different group of patients. Instead, researchers identify and enroll people who have already received a treatment or test in the past for a specific condition and analyze those results.

During the study, participants may be asked to answer questions, and report side effects or other challenges. They may also be asked to contribute biological samples, such as blood, saliva, or tissue that the researcher can test and use for their observations.

Before participating in a clinical study, the potential benefits, risks and alternatives to the study are shared with interested individuals. This is called informed consent.

During the informed consent process, a study staff member will:

✔ Review the study information and what to expect as a study participant.

✔ Provide a form to be read and signed by the individual or their legal caregiver or guardian for permission to participate in the study.

✔ Share written materials and verbal instructions, and answer questions about the study.

The goal of this process is to make sure that every study participant understands the commitment they are making.

Diversity is important to a study because biological, social, and economic factors can affect how people respond to a drug, test, or other intervention.  To make sure that a scientific finding applies to everyone, studies should represent the broad community. This includes 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 community about the importance of diversity in clinical research

✔ Including patient feedback into study design and planning.

An Institutional Review Board (IRB) is a group of clinicians, scientists, patient advocates, and community members. They are tasked with reviewing and approving clinical study protocols (plans), informed consent (written permissions to participate in a study) requirements and other study related materials. Studies involving human participants must be reviewed by an IRB before they can begin and are monitored throughout the study period. The IRB process safeguards the rights and welfare of clinical study participants. The IRB ensures that studies are well designed, ethical, legal and safe.

Anyone can participate in a clinical study if they meet the qualifications for that study. Some common factors that may be considered for study enrollment include:

✔ requiring participants to have a certain health conditions

✔ age at the time of enrollment

✔ whether a participant has previously been treated for the condition being studied.

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

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

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