Clinical Research: Information for Patients and Study Volunteers

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.

ClinicalTrials.gov provides comprehensive information on the standards and protocols followed to ensure that study participants receive adequate information before, during, and after enrolling in a clinical trial.

At Sutter Health, our Institutional Review Board (IRB) reviews, approves, and monitors research involving patients. The IRB is comprised of doctors, researchers, subject matter experts, and members of the community. The IRB ensures that studies are ethical and that the rights and welfare of participants/patients are protected.
Informed consent is the process of learning the key facts about a clinical trial before deciding to participate.

The study investigator will explain the risks and benefits of the study during this process, and the study participant will have an opportunity to ask questions about the study. If the study participant and the investigator agree that the study is a good fit after this discussion, the study participant will be asked to sign a consent form provided by the research team.

The consent form includes details about the study such as its purpose, duration, required procedures, and who to contact for support or questions. The informed consent document also explains risks and potential benefits. If you decide to enroll in the trial, you will need to sign the informed consent document.
Clinical research may involve additional risks to the health of participants. Clinical trials provide participants with an opportunity to help researchers contribute to knowledge about the safety, efficacy or viability of new treatments or procedures. They may also offer access to new, investigational treatments before they are widely available. Learn more about the potential risks and benefits of research participation as described by the National Institutes of Health.
Researchers carefully assess information collected during the study before determining the meaning of the findings and the potential need for further testing. After a phase I or II trial, the U.S. Food and Drug Administration (FDA) decides whether the research should progress to the next phase of investigations, or if the study should be halted or stopped altogether. When a phase III trial is completed, the FDA examines the information and decides whether there is enough data to demonstrate that the new treatment is safe and effective for its intended purpose and can be used outside of a research study. Even when the FDA does not approve a new treatment for clinical use, the results of research studies may still have medical importance and inform future research.

Results from clinical trials are often published in peer-reviewed scientific journals. During the peer review process, experts review the report before it is published to ensure that the analysis and conclusions are sound. Once a new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice. Published study results are also available by searching for the study's official name or Protocol ID number in the National Library of Medicine's PubMed® database.

Ready to explore the clinical trials offered by Sutter Health?

Browse our database of clinical trials relevant to your health concern. Each study provides general contact information to receive more details specific to the research being conducted.

If you find a clinical trial that interests you, please contact ClinicalResearch@sutterhealth.org for more information.

A Sutter Health clinical research team member will contact you using the contact information you provide to further discuss participation. During this call, the research team member may ask you additional questions to determine if you meet the scientific criteria of the study.

References:

¹National Institutes of Health.
²American Cancer Society.

Clinical Research: Information for Patients and Study Volunteers

Why participate in a clinical trial or observational study?

Do I qualify for participation?

Other Frequently Asked Questions

Ready to explore the clinical trials offered by Sutter Health?