Clinical trials aim to improve the medical community’s understanding of various new medical devices and medications, whether those are as complex as cutting-edge drug therapies or as simple as improved blood sugar monitors. But for a trial to be effective, the actual design of the study needs to reflect its unique aims and objectives. Before you enroll in a clinical trial, you might ask yourself: How are these studies designed, and how does that impact study outcomes? Read on to find out more about the basics of clinical trial study design.
Exploring the Basics of Clinical Trial Study Design
Types of Clinical Trials
To understand clinical trial study design, we must first explore the different types of clinical trials:
When you think of clinical trials, you probably picture experimental studies. In these studies, patients are assigned to either an experimental group or control group. The control group receives a placebo treatment (a substance that has no therapeutic effect), while the experimental group receives the treatment being tested. Double-blind randomized trials are considered the “gold standard” of experimental trials, as they offer the highest level of protection against unintentional researcher bias. In double-blind randomized experimental trials, neither the patients nor the researchers know which patients are receiving the placebo treatment.
Unlike experimental studies, observational studies do not involve randomization. Instead, the researcher commits to observing the results of the trial – hence the term “observational study” – without intervening by assigning specific test groups. There are two types of observational studies: analytical and descriptive. Analytical studies explore the relationship between an outcome and a variable – for example, lower blood pressure in patients who may have received a new treatment. Descriptive studies, however, focus on information like patient demographics, disease history, and treatment history to develop a clearer picture of a treatment’s potential impact.
Clinical Trial Study Design Considerations
So, how do researchers choose a certain clinical trial study design? The study design process involves a variety of different factors. First, researchers must work to reduce bias as much as possible, especially in studies that involve patient reflection. For example, if patients are asked to recall the last time they experienced a certain symptom, that can impact the efficacy of a trial. In these cases, researchers may opt for a more quantitatively controlled trial to ensure accurate data. Researchers also have to take several more practical considerations into account. For example, some studies might explore seasonal issues like allergies, cold and flu, or Seasonal Affective Disorder. In these cases, researchers would obviously need to design a study that takes place during a specific time of year – winter, in the case of cold and flu or Seasonal Affective Disorder.
An effective clinical trial can have groundbreaking effects on human health, improving healthcare outcomes in meaningful ways. However, flaws in study design can negatively affect trial data. For this reason, researchers must carefully design each study to best serve the patients involved, as well as the proposed research outcomes.
Have you ever thought about participating in a clinical trial? You could be a part of history! QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. After that, within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.