What is the Difference Between A Clinical Trial and A Clinical Study

People often use the terms "clinical trial" and "clinical study" interchangeably. Both fall under the umbrella term "clinical research," which is the study of health and illness in humans. This research involves people voluntarily participating under conditions set by the clinical researchers. If considering participating in clinical research, it's important to understand the differences between these terms.

What is a Clinical Study?

A clinical study is research using human participants to help experts learn about different medical conditions and treatments. There are two primary types of clinical studies: clinical trials and observational studies. Both are designed to help health care professionals expand their knowledge of viable treatment—or preventative—options for patients, including medications, medical devices, surgery techniques, and therapies (e.g. radiation). Clinical studies may also focus on the development of diagnostic tools to help detect or prevent diseases and other medical conditions.

Who Creates a Clinical Study?

Clinical studies are often sponsored by entities that pay for the research. Typical sponsors are academic medical centers, pharmaceutical companies, voluntary groups, and federal agencies, such as the National Institutes of Health (NIH), Department of Veterans Affairs (VA), and Department of Defense (DoD). Sponsors initiating clinical research want to learn more about medical conditions or identify viable treatments.

Who is in Charge of the Clinical Study?

Every study is led by a principal investigator, usually a medical doctor. It's common for studies to have research teams that include experts of varying degrees of expertise and experience. A clinical study team is often composed of doctors, nurses, social workers, and other types of healthcare professionals. Studies often take place in different facilities, including hospitals, community clinics, universities, or doctors' offices.

Can Anyone Join a Study?

When study parameters are built, the research team sets stringent protocols to help the study succeed. This determines eligibility criteria. Who can join will depend on if they meet established inclusion and exclusion criteria. Common criteria include:

• Age
• Gender
• Ethnicity
• Having specific illnesses or health conditions
• Stage of a disease
• Previous treatment history for a medical condition

Sometimes research teams choose individuals and ask them to participate if they meet predetermined eligibility factors.

What is a Clinical Trial?

A clinical trial is a component of a clinical study. People who participate in clinical trials are directed to follow the specific interventions set by the initial research protocols for the purpose of the study. Interventions may include drugs, devices, or modifications to a participants' behavior (e.g. diet and exercise). Sometimes it'll be a combination of one or more protocols.

What are Research Teams Looking for in Trials?

Trials are designed to help professionals gain insight and knowledge that will help identify effective new treatments or preventative strategies for medical conditions. The research team carefully tracks participants and how they react to the protocols within the study's parameters. To meet these goals, a clinical trial may:

• Compare new with traditional, already-established medical treatments or interventions.
• Compare two established medical treatments or interventions.
• Compare a new drug treatment's effectiveness to a placebo (inert compound).

These are only a handful of techniques used. What the research teams establish depends upon the type of study and the outcome they're seeking (e.g. treatment for specific cancer types or medications to combat diseases) to determine safety and effectiveness.

How are Trials Conducted?

Trials are broken into four phases which are defined by the U.S. Food and Drug Administration (FDA) and established to help researchers find the right dosages, identify potential side effects, and, if all goes as hoped, gain FDA approval for clinical use. Each phase emphasizes a focus on safety and effectiveness.

• Phase I clinical trials are experimental treatments, usually performed on a small group of (often) healthy people of a wide age range. This phase focuses on safety and side effects to determine correct uses or dosages.
• Phase II clinical trials increase the number of participants (100 to 300), putting an emphasis on effectiveness and obtaining preliminary data to see if a drug (or device) works in people with certain diseases or conditions. Phase II can last years.
• Phase III clinical trials increase participants further, frequently to thousands of participants. Researchers look at different populations and dosage amounts, along with using the treatment with other parameters (e.g. drug combinations). If Phase III succeeds, the FDA may approve the experimental drug or device for widespread use.
• Phase IV clinical trials are the final stage where researchers monitor the drug or device's effectiveness and safety in large, diverse populations. Sometimes, side effects or other adverse reactions don't occur immediately, so safety is carefully monitored throughout Phase IV trials in patients that are receiving the new treatments in real-world settings.

People participate in clinical trials for many reasons. Some suffer from diseases where current treatment options don't work for them or there are no treatments at all. Healthy people participate to aid the development of new treatments or preventative measures.

How Can People Join Clinical Trials?

People who want to participate in clinical trials should first speak with their doctor. If their doctor agrees, they may be enrolled in a clinical trial through their medical office or be referred to another center. Other ways to join are to search for clinical trials or join clinicalconnection.com to receive notifications when new trials are available.

ClinicalConnection, founded by pharmaceutical research professionals, has been helping connect people with clinical trials since 2000.