Beginning a Clinical Research Study
Dr. Bruce L. Pihlstrom, DDS, MS
Learn about beginning a clinical research study by identifying a mentor and biostatistician, understanding the basic principles of defining and answering a research question, establishing a testable research hypothesis and choosing an appropriate research design.
1. Learn how to identify and work with a research mentor and a biostatistician
- Characteristics of a good research learner
- Characteristics of a good research mentor
- Establishing an ongoing relationship with a research mentor and statistician
2. Learn the importance and characteristics of a focused research question that forms the basis of a clinical research study.
3. Learn how the research question can be refined using specific steps:
- P for Problem/person/patient/population
- I for Intervention or exposure under consideration
- C for Comparison/Control intervention or exposure
- O for Outcomes
4. Learn how to state the research question as a hypothesis in terms of the independent and dependent variables that can be can be tested in a clinical research study.
- Null hypothesis
- Alternative hypothesis
5. Learn about choosing a research design that is appropriate for the question being asked.
- Observational study (retrospective/prospective)
- Clinical trial
Addtional PDF Resources
Glossary – Definitions of Key Terms
- Alternative Hypothesis
- The alternative hypothesis, H1, is a statement of what a statistical hypothesis test is set up to establish. For example, in a clinical trial of a new drug, the alternative hypothesis might be that the new drug has a different effect, on average, compared to that of the current drug.
- Dependent Variable
- In a statistical analysis, the outcome variable(s) or the variable(s) whose values are a function of other variable(s) (called independent variable(s) in the relationship under study).
- A supposition, arrived at from observation or reflection, that leads to refutable predictions. Any conjecture cast in a form that will allow it to be tested and refuted.
- Independent Variable
- An exposure, risk factor, or other characteristic being observed or measured that is hypothesized to influence an event or manifestation (the dependent variable).
- Null Hypothesis
- The null hypothesis, H0, represents a theory that has been put forward, either because it is believed to be true or because it is to be used as a basis for argument, but has not been proved. For example, in a clinical trial of a new drug, the null hypothesis might be that the new drug is no better, on average, than the current drug.