Protocol
A study protocol is a detailed description of your plan for the study.
Often, much of the protocol will be an expansion of, or be informed by,
the funding proposal materials prepared in the last step.
Common elements in a (clinical research) protocol include:- Reason for the study
- Number of participants to be enrolled
- Eligibility and exclusion criteria
- Detailed account of the intervention
- Data gathering and analysis plan
- Study endpoints
- Observational Study: A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcle, no treatment is given).
- Case Study:
- Case-control Study: A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called retrospective study
- Cohort Study: A research study that compares a particular outcome (such as lung cancer) in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke compared with those who do not smoke).
- Randomized Control (or Clinical) Trial (RCT): including blinded and double-blinded ( A clinical trial in which the medical staff, the patient, and the people who analyze the results do not know the specific type of treatment the patient receives until after the clinical trial is over) studies: A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
- Meta-analysis: A process that analyzes data from different studies done about the same subject. The results of a meta-analysis are usually stronger than the results of any study by itself.
Clinical researchers are encouraged to contact the Study Design and Biostatistics Center early in the research process for an initial, no-cost consultation on their study design.
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