Medical breakthroughs — and even cures — for some of the most pressing health concerns depend on patients’ participation in clinical research. Clinical research helps doctors and researchers learn more about disease and improve health care for people today and in the future.

A clinical research study engages human volunteers (also called study participants or subjects) in research that is intended to contribute to medical knowledge and/or collect information toward the commercialization of a new treatment. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. 

Clinical trials evaluate the effects of a new or investigational intervention (e.g., a drug, device, or health behavior) on health outcomes, and may examine new ways to prevent, detect, or treat disease. Clinical trials may study:

• New drugs or combinations of drugs
• New surgical procedures
• New medical devices
• New ways to use existing treatments
• New ways to change behaviors to improve health
• New ways to improve the quality of life for people with acute or chronic illnesses.

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures (which can include approved medical products such as drugs or devices) as part of their routine medical care, but participants are not typically assigned to specific interventions by the physician investigator (as in a clinical trial).

Why participate in a clinical trial or observational study?

You may decide to take part in a clinical trial for one or more reasons. Some healthy volunteers say they take part to help others and to participate in advancing new scientific and medical knowledge. People with an illness or disease may take part to receive access to new, investigational treatments and to have added care and attention from the clinical trial staff.^1,2 Clinical trials offer participants a chance to help researchers explore new treatment options, which may benefit future patients.

Do I qualify for participation?

Clinical studies (trials and observational) have standards called “eligibility criteria”—the requirements that must be met before a person can enroll in a trial, and that help ensure the trial may be suitable for a participant based on their age, gender, prior treatments, and the location(s) and stage of their cancer, for example. Eligibility criteria help ensure that the scientific goals of the study are met and ensure that your medical history is aligned with the requirements of the study.

Some research studies seek participants who have the illnesses or conditions that will be studied; other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll.

Patients interested in enrolling in clinical trials at Sutter should discuss their potential suitability with the lead investigator of the study and the relevant clinical trial coordinator.

The investigator will explain the risks and benefits of the study in a process called informed consent, and the patient will have an opportunity to ask questions about the study.  If the patient and investigator agree that the study is a good fit after this discussion, the patient will be asked to sign a consent form.

They will also undergo screening tests or procedures to determine if they are eligible for a specific study. Some of these tests and procedures may be part of a study participant’s regular care; others may be performed for the sole purpose of the study. The screening process could last up to 30 days if some of the tests or procedures are performed on different days.