Clinical research involves human participants and is commonly conducted in fields like medicine, biology, psychology, and pharmacology.
This research enables scientists to assess the safety, efficiency, and functionality of medical products, including new medications and therapeutic techniques.
Understanding clinical research design can enhance your knowledge of how scientists conduct this research and improve your own research design skills.
In this article, we define clinical research design, compare observational and experimental design methods, explain the purpose of clinical research, outline its key elements, and discuss its importance.
Types of Clinical Research Designs
In general, there are two types of clinical research designs: observational and experimental. Here are the differences between these design types:
Observational Research Design
Observational research is a methodology where the researcher observes an individual or population without directly influencing the subject of study. In this type of research, scientists perform continuous or regular observations and note any changes that occur over time.
For example, a case study is a common type of observational research. In a case study, the researcher conducts a detailed examination of a single subject, such as a doctor conducting an in-depth analysis of a patient with a rare condition.
Experimental Research Design
Scientists use experimental research designs to answer cause-and-effect questions. Unlike observational designs, experimental research involves scientists imposing a controlled influence on participants to measure its effect.
For instance, a pharmacist studying a new antidepressant medication might design an experiment where they distribute the medication to a test population and assess its effectiveness.
To determine if the medication has a genuine effect, the researcher includes a control group in the experiment.
The control group does not receive the medication, allowing the researcher to compare the results between the control and test groups. If the medicated group shows more improvement than the control group, the researcher can conclude that the medication is likely effective.
Purpose of Clinical Research Design
The purpose of clinical research design is to answer crucial questions that advance scientific knowledge about clinical practices.
By assessing the efficacy and safety of clinical interventions, scientists can enhance treatment options for people seeking medical help. Good research design enables scientists to draw reasonable conclusions from well-supported data.
Additionally, carefully designed clinical studies help avoid biases that could compromise the accuracy of findings. A well-designed study minimizes bias, ensuring that the results accurately and objectively represent the subject of the study.
Clinical Research Design Elements
Although the elements of a research project can vary depending on the type, most clinical studies share common components. Here are some standard elements researchers include in their clinical study designs:
Study Protocol
The study protocol outlines the study’s goals and procedures. It is a detailed document explaining each aspect of the study, including how the researcher plans to recruit participants, gain their informed consent, and compensate them for their contributions.
Researchers also document the protective measures they will implement to ensure the safety of their participants.
Upholding participants’ rights is essential in conducting clinical research, and the study protocol emphasizes the researcher’s plan to protect them. The protocol also addresses concerns such as minimizing biases and securely storing recorded data.
Inclusion Criteria
The inclusion criteria provide guidelines for determining what qualifies a participant for the study. Some participants may not be suitable for certain types of studies, so researchers need clear guidelines to help them select individuals who meet their research needs.
For example, researchers might work only with participants within a particular age range or those already taking a specific medication.
Specifying the inclusion requirements simplifies the selection process for researchers and allows prospective participants to determine whether they are a good fit for the study before applying.
Participant Consent
Having an informed consent form is another crucial document to include in your clinical research design. This form outlines participants’ rights, including their ability to exit the project at any time, and details what participants agree to when they join the project.
Researchers allow participants to review this consent form with their healthcare providers to determine if the clinical project is suitable for them.
Additionally, researchers provide the form in the language in which the participant is most fluent to ensure they fully understand their rights and the risks of participation.
The form’s purpose is to ensure the participant comprehensively understands their rights and any potential risks. Given that a consent form can have legal implications, it’s essential that researchers carefully draft and review it.
Compensation
Some clinical studies compensate participants for their engagement. Offering financial or non-monetary forms of compensation can effectively attract participants to a research study, but researchers must disclose any compensation offered as part of their study plan.
Researchers state the guidelines for receiving compensation so participants understand the conditions under which they receive payment.
For example, researchers may choose to compensate only those participants who complete the project, while others may compensate all participants, even if they drop out of the study.
Other factors to account for with compensation include the form of compensation and the amount offered.
Some trials may reimburse any expenses a participant incurs as a direct result of the study, which means the researcher likely needs a system for tracking participant spending. When offering compensation, researchers may also need to implement a system to verify candidate backgrounds to prevent participant fraud.
Additionally, researchers may need to report the source of any financial compensation offered.
For example, it could indicate a potential bias if a private company sponsors a study and offers participant compensation.
Benefits of Clinical Research Design
Clinical research design is crucial for ensuring research validity, protecting participant rights, and advancing knowledge of clinical practices.
Here are some benefits of a well-structured clinical research design:
Minimizing Biases
Good research design inherently minimizes the potential for biases. Researchers take precautions, such as randomly assigning participants to test or control groups, to prevent selection biases or biases in participant self-reported data.
For example, knowing they received a placebo can affect a participant’s behavior and perceptions, potentially skewing the study’s results. A well-designed study minimizes such risks, ensuring more reliable and accurate outcomes.
Advancing Clinical Knowledge
Clinical research forms the foundation of scientific advancement in healthcare. This research helps scientists assess the viability of new treatments, contributing to healthier, more fulfilling lives for people.
Through well-informed research methodologies, scientists gain insights into human health needs and the clinical interventions that can support wellness goals.
Upholding Participant Rights
A well-designed clinical study supports and upholds the rights of its participants. Legal standards protect research participants, and researchers must account for these laws in their study designs. By meeting all ethical standards, researchers ensure participant safety and reinforce their own professional credibility.