What Are the Different Types of Clinical Research?

The term clinical research is commonly used, but many are confused by the different goals and research types due to the wide variety of clinical studies available. Clinical research determines the safety and effectiveness of medications, devices, treatments and more. Without clinical research, there would be no medical advancements and ailments such as polio, smallpox, and leprosy would still affect Americans and others all over the world. Because of clinical research and trials, we may see cures for diseases such as cancer, HIV/AIDS, and even Alzheimer's within our lifetime.

The classifications of clinical research differ based on the goal of the study. Not all individuals will be eligible for the desired research study in which they wish to enroll. The factors that determine a patient’s eligibility for a clinical trial are known as ‘inclusion and exclusion criteria’. Inclusion and exclusion criteria can be strict for studies based on the treatment or drug being used.

Different Types of Clinical Research

• Treatment research: Involves the research of a new therapy for treating an illness or disease. These can be new approaches to surgery, chemotherapy, radiation therapy, psychotherapy, etc.
• Prevention research: Studies different ways to prevent disorders from developing or returning using lifestyle changes, vitamins/minerals, vaccines and more.
• Diagnostic research: Improves the current methods of detection and diagnosing disorders or diseases including cancer.
• Screening research: Improves the technology or method of detecting disorders or conditions.
• Quality of life research: Looks to improve the lives of those with chronic illnesses by relieving their symptoms and improving their quality of life.
• Genetic studies: Study specific genes to understand how they relate to the development and progression of specific illnesses. This will give insight on the prognosis for certain diseases and the response to tailored treatments.
• Epidemiological studies: Try to understand the incidence of disorders in different demographics identifying patterns and causes.

For many clinical studies, healthy volunteers are required so the researchers have a control group to compare results to the patients with the illness in the research study.

Phases of Clinical Trials

For clinical research to be approved and used for commercial use, a clinical trial will need to be completed. According to ClinicalTrials.gov, a clinical trial is defined as “A research study to answer specific questions about vaccines, new therapies or new ways of using known treatments”. There are 3 main phases of clinical trials – phases 1 to 3. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed. Without clinical trials, there would be no new treatments in development for cancer.

In some studies, subjects will be given a small dose of the drug being tested. Researchers monitor how the drug is affecting you, and how your body copes with the drug. Long-term data about the efficacy and safety of a drug or device are gathered.

The clinical trial process is long, so that by the time drugs reach the public, they have been thoroughly evaluated. FDA experts analyze the results from clinical trials to determine whether new therapies are safe and more effective than established treatments. But the length of the process is one reason why it's so important for volunteers to take part. Without enough volunteers, up to 80% of clinical trials are delayed, which means a delay in potentially life saving treatments.

Sources:

FDA
Clinicaltrials.gov