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Maureen G. Phipps Daniel W. Cramer
Clinical research includes a range of research disciplines and approaches, including patient-oriented research, clinical trials, epidemiology, and outcomes research.
Patient-oriented research centers on understanding mechanisms of human disease, studies of therapies, or interventions for disease.
Clinical trials use a controlled experimental design to assess the effectiveness of an intervention on an outcome.
Epidemiology is the study of the distribution and determinants of health and disease in specific populations.
Outcomes research and health services research include studies that seek to identify the most effective and efficient intervention, treatments, and services for patient care.
Study designs include experimental studies (clinical trials), observational studies (cohort studies, case-control studies, and cross-sectional studies), and descriptive studies (case reports and case series).
Scientific validity of a research study is evaluated by understanding the study question, how the study was designed, and whether chance, bias, or confounding could have accounted for the findings.
Medical practice is evolving to include complex options for patient treatment and preventive care, in part because clinical research methods and techniques to guide patient care have advanced. To evaluate whether new treatments and diagnostic approaches should be integrated into clinical practice or decide whether observational data reported in the literature is relevant, clinicians should understand the fundamental strengths and limitations of clinical research methods and the level of evidence different types of studies provide.
As outlined by the National Institute of Child Health and Human Development, clinical research includes patient-oriented research involving understanding mechanisms of human disease, studies of therapies or interventions for disease, clinical trials, and technology development.
Epidemiologic methods and behavioral research are used in clinical research to examine the distribution of disease and the factors that affect health and how people make health-related decisions. Outcomes research and health services research include studies that seek to identify the most effective and efficient intervention, treatments, and services for patient care (1).
The purpose of a research study is to test a hypothesis about and to measure an association between exposure (or treatment) and disease occurrence (or prevention). The type of study design inﬂuences the way the study results should be interpreted.
Analytic studies are often subdivided into experimental studies (clinical trials) and observational studies (cohort studies, case-control studies, and cross-sectional studies).
Descriptive studies (case reports and case series) often provide useful information for informing future analytic studies.
The common types of clinical research study methods, considerations for the strength of evidence for the specific study design, and interpretation of the results are presented. Although there is debate about which system should be used for evaluating the strength of evidence from an individual study, a well-designed and executed clinical trial presents the highest level of evidence (2). Other types of studies should be designed to best approach the strengths of a clinical trial.