We recently shared highlights from our first clinical study—the Needed Prenatal Nutrient Status Study. It raised great questions from our community: What exactly is clinical research? How should I interpret results from studies like this one?
In this post, we break it down in simple terms—so you can better understand our work, make informed choices, and feel confident engaging with scientific information, whether it’s ours or someone else’s.
Under the US federal regulations, research is defined as “A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Let’s break this down. A systematic investigation follows a replicable and methodological plan, focuses on a specific question or problem, uses reliable methods to collect and analyze data, and importantly is theoretically centered. It builds on what others have discovered and aims to produce generalizable knowledge—findings that can apply to broader groups or situations and/or help develop or test theories, guide decision-making, or shape policies.
So, research is rigorously designed towards enhancing general knowledge. Under this umbrella, clinical research is most simply research that involves people, with the mission of improving human health.
An important aspect of understanding clinical research is the distinction between the types of studies. Let’s start with a breakdown of terminology.
Broadly, there are two main types of clinical research studies: (1) observational studies (type of clinical study) and (2) interventional studies (type of clinical study called a clinical trial). And, they both play key roles in advancing public health! Now, let’s dig deeper.
But first, a note on research involving human participants: Clinical research studies, which involve human participants, also undergo review and approval before they begin to ensure the protection of participants. This review is completed by an independent group called an Institutional Review Board (IRB) which consists of appropriately qualified individuals designated to review the study protocol and ensure the protection of human participants. An IRB has the responsibility in their review to approve, deny, or request modifications to the study, making this a crucial step to building public trust in research!
Okay–back to our breakdown of clinical research studies!
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An observational study is one that observes participants (without changing a participant’s care or lifestyle) who belong to specific groups based on characteristics of interest for human health, and measures or analyzes certain important health-related characteristics in said groups.
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A cross-sectional approach is a type of observational study that collects data at a single time point or over a short period of time (Our Prenatal Nutrient Status Study was an observational, cross sectional study!--more on this below).
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Our study was also decentralized, this means that participants were able to complete all the research activities at their home or convenient locations (rather than a traditional clinical research site, such as a university).
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A clinical trial is a type of clinical study in which human participants are assigned to receive an intervention, which enables researchers to examine the effects of this intervention over a specified amount of time. An intervention describes the applied action in the study, which could include a drug, educational tool, behavioral modification, or even a dietary supplement - to evaluate effects on parameters of human health. In clinical trials, participants are often assigned randomly (or by chance) to an intervention.
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Clinical trials often include intervention group(s) as well control groups(s). A control group is one that does not receive the intervention being researched in the study and serves as a comparison group. This allows scientists to compare the difference in the specified health outcome between the intervention and control groups, to better understand the effect of the intervention applied.
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Often control groups in clinical trials receive a “placebo” (i.e., placebo-controlled trials) – a substance which looks like the active intervention, but is ‘inactive’ or without the treatment value of the intervention. Applying a placebo in the same way as an intervention allows for comparison between the groups.
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You may have heard the term “blinding” in relation to clinical trials, which relates to participants not knowing which treatment is being used (e.g., intervention or placebo). A single-blind study means that the participants do know which treatment they receive, and a double-blind study means both participants and certain members of the research team are not told which treatment is being received. Double-blinded studies help reduce bias from both participants and researchers in intervention studies.
You will also hear researchers discussing the “significance” of their results. While results can be clinically meaningful, these statements refer to statistical significance – or a systematic mathematical assessment of whether the results, such as differences between groups, are greater than would be expected by chance.
Common Misconceptions About Observational Studies (compared to ‘gold standard’ randomized controlled clinical trials):
While randomized controlled trials (RCTs) are often called the “gold standard” in research because they prospectively test interventions by randomly assigning people to groups, they aren't always possible (e.g., ethical, feasible) or the best fit for every research question. Common misconceptions regarding observational studies include that they have ‘less value’ compared to RCTs.
Rather than viewing RCTs and observational research as competing approaches, it’s important to recognize that they each serve different, yet complementary roles in advancing health knowledge. This is particularly true in the scope of women’s health, considering the historical exclusion of women from biomedical research and the critical knowledge gaps that remain to be filled through clinical research. Both types of studies are subject to distinct strengths and limitations, calling for a shift in focus from solely ‘type of study design’ to the rigor of the approach with respect to the research question. RCTs also often require participants to meet strict eligibility criteria, which can lead to exclusion of individuals from underrepresented groups. When thoughtfully designed, observational studies can provide valuable real-world evidence—offering insights that help fill the gaps that arise between preclinical research (e.g., animal studies) and interventional RCTs. Cross-sectional, observational studies allow researchers to gather data on health status, determinants of health, and describe features of populations—without requiring an intervention.
For example, our Prenatal Nutrient Status Study set out to help address the knowledge gap which exists regarding objective nutritional status data in pregnant US women. Our primary objective was to assess the nutritional status among pregnant women taking a ‘standard’ folic-acid containing prenatal vitamin. These commonly used prenatal supplements are typically formulated to meet basic recommendations for certain nutrients, but may fall short in key nutrients evidenced to support optimal health in pregnancy. Therefore, we selected an appropriate clinical study design to match this objective—an observational, cross-sectional, clinical research study which analyzed fasting blood levels of nutrients among adult pregnant US women taking a Standard Prenatal vitamin. As part of this study, we also enrolled a sample of pregnant women taking the Needed Multi Prenatals, to explore whether micronutrient status differs by the type of prenatal supplement used in the current pregnancy.
We thoughtfully and rigorously designed this study to provide real-world evidence regarding prenatal nutritional status among US women taking prenatal supplements and to inform the design of our future clinical research studies.
In short: Clinical research is how we learn what truly supports health—by studying people, their biology, and their behaviors. Some studies test interventions directly (clinical trials), while others observe what’s happening in real life (observational studies, like our first one). Both types are essential to advancing care and filling gaps in knowledge, especially in areas like women’s health that have historically been under-researched.
We’re proud to invest in this work, and we hope this post gives you the tools to better understand—and trust—the science behind our products and our mission.
Happy researching!
