What is Clinical Research?

You have probably heard of clinical studies and clinical trials and may be wondering – whether they differ (quick answer–yes, they do!), why they matter, and how to interpret their results. 

We just completed our first observational cross-sectional clinical study, and we’re here to give you a beginner’s breakdown of clinical research, so that you are armed with the knowledge to understand the design and findings of our studies and others! The language of clinical research allows scientists to communicate their own study approaches and results, as well as evaluate the work of other scientists. However, you don’t need to be a “clinical research scientist” to think like one or appreciate the importance of research findings.  

To Understand Better What Clinical Research is, We Should First Take a Few Steps Back and Ask – What is Research?

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. With this, clinical research exists at the core of enhancing population health. An important aspect of understanding clinical research is the distinction between the types of studies. Let’s dig deeper with a breakdown of terminology.

Broadly, there are two main types of clinical research studies– observational studies (type of clinical study) and interventional studies (type of clinical study called a clinical trial). So, while all clinical trials are considered clinical research studies – not all clinical studies are clinical trials.

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!

Back to Our Discussion On Clinical Research Studies.

• An observational study is one that observes (without changing a participant’s care or lifestyle) participants 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. (This is the type of study we conducted! We were interested in comparing nutritional characteristics of pregnant women based on the type of prenatal they were already taking during their pregnancy – either a standard prenatal or a Needed Multi Prenatal)

• 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 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).

• 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.

• 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.

• 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.

• 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.

Putting it all together, research is a systematic investigation developed to inform generalizable knowledge. Clinical research is a type of research, which involves human participants. Observational studies are a key aspect of clinical research which observe groups of interest and collect or analyze important health-related data, without assigning participants to an intervention. Clinical trials are interventional studies which test promising interventions on human health outcomes to understand if they are safe and effective. It's that simple, and that complicated. Clinical research is the cornerstone of health progress, offering a pathway from understanding and discovery to improving public health while maintaining participant safety and trust. However, as with all complex topics relating to public health, you deserve to be armed with this understanding to interpret the importance of clinical research findings and the value of study participation.

Happy researching!