What is Clinical Research?
Clinical research is about finding the best way for patients to receive medical care. The NIH defines clinical research in three parts: a) patient-oriented (research involving interaction with human subjects), b) epidemiologic and behavioral, and c) outcomes and health services research. In each of these cases, researchers are looking to study how to improve health.
Clinical research includes clinical trials, which are studies that evaluate the effectiveness and safety of medical devices or drugs. These studies are conducted according to a formal protocol, which defines what kind of patient can participate, when and how much treatment is given, what is being measured, and the overall duration of the study.
Clinical Trial Phases
Clinical trials progress in phases, moving toward use for patient care after the drug or device has been thoroughly studied for effectiveness and safety. The phases of clinical trials, which each new treatment must pass to be introduced into the market include:
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The 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: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Research Designs Used in Clinical Research
There are numerous research designs used for clinical research, including descriptive, exploratory, and experimental studies.
Descriptive Research-Descriptive research makes observations about patients or health-related conditions. Usually, this research includes a small sample of patients and intensively studies them to gain insight into the subject of interest. Examples include case-studies, qualitative research, or surveys.
Exploratory Research-Exploratory research examines patients or conditions that have not been extensively studied. Exploratory research looks to clarify or define a problem. Often, relationships or associations are looked for in order to better understand a disease or disorder. For instance, a study may discover a relationship between lifestyle factors and a particular disease. Examples include case-control studies, pilot studies, cohort studies, and historical research.
Experimental Research-Experimental research involves comparing two groups of people. Generally, one of the groups receives an intervention or treatment and the other does not. The purpose of this research is to examine the effect of the intervention. These designs, when randomization is used, are viewed as the "gold standard" in clinical research because the design allows researchers to rule out most, if not all, alternative explanations regarding their results. For example, a researcher may compare a group of patients receiving a placebo drug versus a group receiving an experimental drug. If the two groups are similar at the outset of the study, any differences at the conclusion of the study (e.g., improvement in the disease or disorder in the experimental group) can be attributed to the experimental drug.