Understanding the differences between a clinical trial and a clinical study is essential in medical research. While all clinical trials fall under the category of clinical studies, the reverse is not always true.

Clinical trials specifically test new treatments or interventions through controlled experiments with human volunteers. In contrast, clinical studies encompass a broader range of research procedures. These distinctions are important because they influence how treatments are evaluated, and healthcare decisions are made.

In this blog, we will explore the four primary differences between clinical trials and clinical studies to provide clarity on their respective roles and processes.

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Understand clinical trials & clinical study

Before identifying their differences, it is vital to understand what each term means.

What is a clinical study?

A clinical study means any investigation in relation to humans intended to examine how a medicine works, its side effects, and how the body processes it to determine its safety and effectiveness. A clinical study aims to determine the safety and effectiveness of the medicine.

Researchers may look at how the medicine is absorbed, distributed, metabolised, and excreted by the body, as well as any potential adverse reactions. This helps ensure the medicine is safe and effective for patients.

What is a clinical trial?

A clinical trial is a specific type of clinical study. A clinical trial is an essential phase in introducing new medical treatments, drugs, or procedures to the market. These trials involve human volunteers who participate in carefully controlled studies to evaluate the safety and effectiveness of the interventions being tested.

What are the differences between a clinical trial and a clinical study?

While a clinical trial is a type of clinical study, not all clinical studies are clinical trials. It is essential to distinguish between the two to understand their unique purposes and procedures.

Observational versus interventional

There are two types of clinical study, observational and interventional. Clinical trials are interventional studies, meaning they involve testing a specific intervention in a controlled setting to evaluate its effects. For example, a clinical trial could be testing a potential drug, procedure or device.

Observational studies, on the other hand, involve monitoring participants and recording the effects of their current treatment without making any changes.

Participants will typically be people undergoing treatment for a medical condition, and the researchers will collect information about the results of that treatment without changing it or comparing the results to a control group. This category includes epidemiological studies and other investigations that do not involve testing an intervention.

Objectives

Clinical trials and clinical studies have distinct objectives. The primary goal of a clinical trial is to determine whether a new intervention is more effective than existing treatments and to assess its safety for a specific population.

Clinical studies’ objectives can vary. Clinical studies aim to identify patterns, risk factors, or associations between variables and health outcomes. For example, epidemiological studies focus on determining the incidence and prevalence of diseases, as well as identifying potential risk factors and trends.

Phases and types

The process of conducting clinical trials involves distinct phases, each with specific goals. These phases of clinical trials play an important part in determining the efficacy and safety of the intervention that they have created.

Clinical studies, however, can vary widely. Observational studies come in several types, including case studies, ecological studies, cross-sectional studies, case-control studies, and cohort studies, each used in different research contexts.

Participants

The participants in clinical trials and clinical studies differ as well. Clinical trials typically require a large number of participants, segmented by eligibility criteria such as age, health status, and medical history.

Clinical studies, however, often involve fewer participants based on the characteristics of studies. Like case studies, clinical studies may focus on detailed descriptions of just one or a few patients, compared to larger groups.

What are examples of a clinical study and clinical trial?

Clinical studies and trials come in various forms. For instance, clinical studies include epidemiological studies, which track disease prevalence, and case-control studies, which compare patients with a condition to those without it.

On the other hand, clinical trials involve testing new treatments in controlled settings. Examples of clinical trials conducted by FluCamp include:

  • Flu clinical trials: Evaluating new treatments and vaccines for influenza.
  • Asthma clinical trials: Studying medications and therapies for managing asthma symptoms.
  • RSV vaccine trials: Investigating vaccines against the respiratory syncytial virus.
  • COVID-19 vaccine trials: Assessing vaccines for prevention of COVID-19.

These trials aim to advance medical knowledge and improve treatments for these conditions.

What next?

If you are interested in participating in a clinical trial or have any questions about safety, we invite you to contact us to learn more about FluCamp studies.