Our clinical study was double-blind, university-backed, randomized, and placebo-controlled.

Confused? We know—without definitions, understanding what any of this means can be… tricky, to say the least. But these words are also pretty powerful, so allow us to explain.

Clinical research terminology provides a universal language for scientists across the world to communicate their findings and describe their study design. And that means the details really matter—there’s a difference between a “clinical study” and a “clinical trial,” for example.

That said, we don’t think a PhD should be a baseline requirement to understand the significance of clinical research. So consider this a crash course on key clinical research terms to know.

Class is in session!

Clinical Glossary

• Clinical study: A clinical study refers to a research study that 1) involves human volunteers, also known as participants and 2) is conducted for the purpose of enhancing medical knowledge. There are two types of clinical studies—the first type is an observational study, and the second type is a clinical trial (also called an interventional study). (1)

• Clinical trial: Clinical trials are a type of clinical study where participants are assigned to groups that receive one or more intervention (or no intervention), allowing researchers to evaluate the effects of said intervention(s). Also referred to as an interventional study, this is the type we conducted for our clinical study of Essential for Women Multivitamin 18+. (1)

• Observational study: A type of clinical study, observational studies identify participants as belonging to specific study groups (rather than assigning them to a specific treatment group), then assess them for outcomes. A patient registry is a good example: It collects info about individuals’ conditions and/or interventions in order to gain a better picture of how people in the real world react. (1)

• Intervention: Interventions refer to a process or action that is the focus of a clinical study—these can range from medical devices and drugs to procedures and products (in our case, our multivitamin Essential for Women 18+). They can also include lifestyle modifications, like education, or changes to diet and exercise. (1)

• Double-blind study: This refers to a type of clinical trial where neither the researcher nor the participant(s) knows which intervention the participants are receiving until the trial is over. Typically, this is the preferable option when it comes to scientific research—since the researchers are “in the dark” so to speak, the results of the study are less likely to be biased. (2)

• Placebo: A placebo is an inactive substance (or intervention) that looks the same as—and is administered the same way as—the intervention being tested. The effects of the intervention are compared to the effects of the placebo. (A placebo-controlled trial refers to a study in which the control patients receive a placebo.) (1)

• Control group: This refers to the group that does not receive the intervention being studied in a clinical trial. The results from this group are compared with the results of the group that does receive the intervention, which allows researchers to measure the difference. (2)

• Randomized: In contrast to non-randomized studies, randomized studies mean participants are assigned to an intervention by chance. Similar to a double-blind study, randomization helps reduce bias and is seen as the preferred method in terms of credibility and rigor. Another plus? It enhances internal validity—another way of saying it’s able to demonstrate a cause-and-effect relationship. (1)

• Gold standard study design: “There’s a hierarchy in terms of the quality of evidence behind a product,” explains Dr. Nima Alamdari, Ritual’s Chief Scientific Officer. “Randomized, double-blind, placebo-controlled studies are considered to be the gold standard study design.”* (3)

• University-led: This means that a clinical study was conducted by a research university (in our case, Auburn University), but that funding for the trial may come from a different organization, known as the funder. ClinicalTrials.gov outlines four funder types: U.S. National Institutes of Health, other U.S. Federal Agencies (like the FDA), industry funders (like pharmaceutical companies), and all others (like universities and community-based organizations). (1)

• Significant: Also referred to as statistical significance, this term describes the mathematical difference between groups—the results are said to be significant only if the difference is greater than what is expected to happen by chance alone (which ours were). (2)

• Peer review: Peer review refers to the process by which original articles written by researchers undergo evaluation of technical and scientific quality and accuracy by other experts in the same field. Our clinical study was published in a peer-reviewed scientific journal—which is one of the highest awards scientific research can achieve.† (2)

References:

1. National Institutes of Health. (2020, December). Glossary of Common Site Terms. ClinicalTrials.gov.
2. National Institutes of Health. (n.d.). NCI Dictionary of …. Terms. National Cancer Institute.
3. Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology, 125(13), 1716.

†This content was created for informational use, and should not be read to recommend, endorse, or associate any specific products. We recommend speaking with a healthcare provider to determine the right route for you.