Patient Registry Study Essay

653 Words2 Pages

Designing and conducting a registry study is not much different than executing a clinical study. All the basic elements of design, planning, and project management are available in both patient registry and clinical study. There is a lack of agreement standards for registry studies so it is difficult to find guidance on how to do them. Registry studies are observational and clinical studies are investigational. The foreseeable features of registries are effectiveness and efficacy. Effectiveness refers to how well a device performs as projected in the general population of patients and the general confusion of clinical practice. Efficacy refers to how well a device performs in a setting of carefully selected patients and a carefully controlled protocol. Effectiveness is measured in patient registry studies and efficacy is measured in clinical studies. In order to plan …show more content…

Increase of accessibility in RWE: Research are often designed by researchers, but used by non-skilled people either by patient, providers or payers so we need to make sure the terms that are used to describe the researchers are reliable and be simple clear by everyone.
2. Design the study with questions to answer: To design the study by keeping in mind of end-user of the product/ research. This can be done by including the end user in study design & what types of evidence group is to answer the questions they have.
3. Transparency of Data: With the availability of electronic data software’s we can increase the reliability, transparency of the research & show all that what it means.
The following methods3 can be used as good practices while designing RWE:
Operational features:
Selection of Sponsors
Each sponsor has different ideas about the project and it's importance. Each sponsor will have different interests on selecting a project, will have different expectations on the results of the project and will have different definitions on project success. Each sponsor will have different requirements

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