Clinical research is a branch of healthcare science that determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice accepted treatments are used, while in clinical research evidence is collected to produce a treatment.
The term “clinical research” means the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article including its safety, toxicity if applicable and efficacy, if possible at this early stage are studied.
Different types of clinical research are used depending on what the researchers are studying.
Treatment Research generally includes an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic Research means the practice of looking for better ways to identify a particular disorder or condition.
Screening Research aims to find the best ways to detect certain disorders or health conditions.
Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses may be related. Research in this area may explore ways in which a person’s genes make him or her more or less likely to develop a disorder. This may lead to development of tailor-made treatments based on a patient’s genetic make-up.
Epidemiological studies seek to identify the patterns, causes, and control of disorders in groups of people.
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years.
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications.
Phase I trials
Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
Phase II trials
The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III trials
The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase IV trials
Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.
- have the goal of increasing medical knowledge
- be carried out by competent persons
- take all necessary measures to protect those who lend themselves to research
- obtain regulatory approvals and take all the necessary legal and ethical steps
- collect the consent of those involved in research