A clinical study is a research study on human volunteers or participants to determine how well a new drug or medical approach can function in people. Some common reasons to design a clinical study are to evaluate one or more interventions for curing a disease or devise ways that can help prevent the occurrence of a disease. Additionally, you may want to examine methods for determining a disorder or the risk factors for that disorder.
Initially, designing clinical studies was complex and time-consuming. However, with the advent of technology, you can now standardize and automate your clinical study processes. You could try this in your studies and place all your data in one location. This approach enables you to manage, find, share and reuse data. With that said, here’s a simple beginner’s guide to designing clinical studies.
Types Of Clinical Studies
There are two major types of clinical studies:
Observational Study Design
In this study, you observe the impacts of medicine, diagnostic tests, risk factors, or other interventions without altering who is or isn’t exposed to it. Some study designs that fall under this category include:
- Ecological study: Compares large groups of people representing a shared characteristic.
- Cross-sectional study: This study design assesses a connection between exposure and outcome at the exact moment.
- Cohort study: This study compares two groups, such as those with and without exposure over a period of time, for the difference in the occurrence of a disease or an outcome.
- Case-control study: This compares two groups, like those with diseases or cases, to those without disease or controls and examines their difference in risk factors.
- Nested case-control study: This involves establishing a cohort with suspicious risk factors and allocating a control within the cohort to the subject who becomes sick.
Experimental Study Design
This design’s fundamental concept is to examine an intervention’s impact. Here, you control the exposure of interest, risk factor, or treatment. Since it consists of hypothesis studies that provide convincing evidence, it requires careful planning and resources for you to achieve accurate results. It can be classified into two groups. The first group is controlled or with comparison, and the second is uncontrolled or without contrast.
This design can be divided into three broad categories as outlined below:
- Community trial: Also referred to as cluster-randomized trials, community trials involve groups of persons with and lacking a disease located in various experimental groups. The results obtained are on a large scale; hence you won’t be able to account for intra- or inter-individual variability.
- Field trial: In this type of trial, you place healthy people in diverse preventive intervention groups and monitor them over time for the appearance of a particular disease process.
- Clinical trial: This involves placing subjects with the disease in different treatments and monitoring their reactions to certain medications and treatment options.
Methodologies You Can Use To Design Your Clinical Studies
There are various methodologies you can use when designing your clinical study. They include:
- Using a placebo: A placebo is a drug that resembles the actual medication you’d use in your study but without the active substance. It’s usually used in clinical studies to determine the safety and efficacy of an intervention or drug.
- Blinding: This is a methodology you can adopt to intentionally not give information linking to assigning participants to the various groups. It aims to lower the effects of the knowledge of being in a particular group on the study outcomes.
- Randomization: Participants are assigned by chance to separate groups that are given different treatments or interventions. It aims to prevent bias during subject selection, which can affect the results of your intervention.
- Bias: This refers to any systematic error in your design that may lead to a mistaken estimate of an exposure’s assessment of the risk of disease. The three significant biases in designing a clinical study are selection, observer, and information biases. In observer bias, systematic errors occur when particular features of the group influence you. For instance, you may pay close attention to a group receiving treatment and abandon the one not receiving it. Information bias is when an error occurs while you obtain data from the study subjects.
Finally, selection bias is when a systematic error occurs when you’re selecting the subject for your study. Therefore, when designing your analysis, it’s essential to take careful measures that limit bias to obtain valid results.
How To Design A Clinical Study
To design a successful clinical study:
- Create a verifiable hypothesis. A successful clinical study requires you to form a testable hypothesis that can help you connect your underlying theory and specific research question. It also enables you to identify the necessary components for your study and the gears that can help you protect yourself at work.
- Select your participants and associated experts.As a beginner, you’d need help from professionals to design your clinical studies. Additionally, participants or subjects play a crucial role here.
- Design the study. After the above steps, you need to devise the study. Execute an easy way of communicating with the participants to acquire feedback.
- Test the design. Before the actual study, consider checking for factors or events that can influence the outcomes.
Designing a clinical study shouldn’t be nerve-racking if you know what it entails. You need to choose the type of study you’ll adopt and the methodologies you can use.
Additionally, knowing the steps you’ll take to design your clinical study goes a long way to simplifying your process. With the above information, you can build your clinical study within a fraction of the time and augment your quality and consistency.