Research and Clinical Trials

It’s important to understand the difference between your usual care and clinical research. When you visit your doctor, your doctor diagnoses and treats your current illness or condition. During clinical research, however, researchers are trying to gather new knowledge that will help them improve medical care for people like you in the future.  You will continue to receive medical care that meets the standards of care (the normally accepted treatment) for your condition. Your doctor can talk with you more specifically. SCL Health invites you to visit with your medical care team to explore your participation in clinical research. 

Clinical research involves people who volunteer to participate in the research. Through clinical research, researchers try to better understand how to diagnose, treat and prevent diseases or conditions, and gather new knowledge that will help them improve medical care for people in the future.

There are three types of clinical research: 

1. Clinical trial (interventional study) - During clinical trials, researchers learn if a new test or intervention works and is safe. Interventional studies in clinical trials might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
2. Observational study - In this type of study, people are observed or certain effects are measured. No research procedures or interventions are  given by the researcher.
3. Medical records research - Medical records research involves the use of information collected from medical records only. By studying the medical records of large groups of people over long periods of time, researchers can see how diseases progress and which treatments and surgeries work best.

Resources: NIH What are Clinical Trials and Research Studies?  

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials offer hope for many people and an opportunity to help researchers find better care for others in the future.

Resources: NIH Why Should I Participate in a Research Study? 

Clinical trials may involve risks, as can routine medical care and the activities of daily living.  The specific risks associated with a clinical trial are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research. 

Resources: NIH Clinical Trials: Benefits, Risks, and Safety and NIH Clinical Research Trials and You 

A placebo is an inactive drug or treatment in a clinical trial. Not all trials involve the use of a placebo. However, in place-controlled clinical trials, some study participants will be assigned to a “control arm” or “control group” in the study. Those who are in the control arm will not receive the new medication, device or treatment that is under study, to provide a comparison to see how the innovation compares against no treatment, or how it compares to an existing treatment. Members of the control group may receive a placebo, an inactive treatment such as a pill that makes the group think they are receiving the new treatment. If the trial you are considering does involve placebos, a research team member will discuss this information and related details with you prior to, or as part of your initial screening.

Resources: Cancer.net Placebos in Cancer Clinical Trials and  Clara Health Placebos in Clinical Trials

Before deciding to participate in a clinical trial, you will meet with our clinical trial's research team to learn about the study. You can ask our team any questions you have. They should answer your questions in a way that helps you easily understand. This will help you make an informed decision about joining the clinical trial.

Resources:  Cancer.gov What to Ask Your Doctor About Clinical Trials

The key difference is that for clinical care/medical treatment, currently accepted medical procedures and products (i.e., standard care) are used to treat you, whereas in clinical research, new medical procedures and/or products are used to treat you, often along with standard medical treatments, to determine if they are an improvement to or in combination with current therapies.  Participating in a clinical research study is completely voluntary.  Regardless of whether or not you participate in a clinical research study, you will receive the best possible clinical care/medical treatment currently available.  

Resources: FDA - Clinical Research Versus Medical Treatment and OHRP - About Reseach Participation 

Who can participate in clinical trials and clinical trial eligibility requirements are determined by inclusion and exclusion criteria. The reasons that allow you to volunteer for a clinical trial are inclusion criteria, and the reasons that may disqualify you are exclusion criteria. Inclusion and exclusion criteria are based on what a clinical trial intends to learn about and safety of research participants, and detailed in the study protocol.  They are generally listed in clinical trial databases and briefly in study advertisements you may see or hear. The objectives of a clinical trial, also described in the clinical trial protocol, will also dictate participants’ eligibility, i.e., healthy or categorized by specific illnesses or conditions.

Inclusion and exclusion criteria may include:

• Age
• Gender
• Stage or severity of a disease
• Previous treatments a patient did or did not take
• Medications a patient is currently taking
• Medical conditions other than the one being studied.

To meet clinical trial eligibility, you must satisfy both the inclusion and exclusion criteria. Once you've contacted the medical facility in your area that is running the clinical trial, the medical research team will go through the informed consent process with you. After you signed your consent form, you may be asked to undergo an additional screening process as outlined in the specific clinical trial protocol.

Reference: ClinicalTrialsAndMe.com Eligibility for Clinical Trials

No, from the time you consider participating and throughout the time you are enrolled in a clinical trial, your participation is voluntary. You have the right to discontinue your participation for any reason at any time during your participation. You do not give up any rights by deciding to participate in a clinical decision.  By the same token, you do not lose any care you are entitled to by deciding to stop your participation.  People stop participating for various reasons.   Your decision is voluntary and respected. 

Resources: American Cancer Society Being in a Clinical Trial

• Phase 0 trials are the first clinical trials done among people using a very small dose of a new drug in a few people to make sure it isn’t harmful to humans before they start using it in higher doses for later phases. 
• Phase I trials aim to find the best dose of a new drug with the fewest side effects.
• Phase II trials further assess safety as well as if a drug works. 
• Phase III trials compare a new drug to the standard-of-care drug. 
• Phase IV trials test new drugs approved by the FDA.

Resources: NCCN Clinical Trial Phases and FDA Drug Development Process Step 3 Clinical Research