Secondary Use of Data: Non-Interventional Study Best Practices in Planning and Protocol Development
Well established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the impleme...
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| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Columbia Data Analytics, LLC
2017-04-01
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| Series: | Journal of Health Economics and Outcomes Research |
| Online Access: | https://doi.org/10.36469/9796 |
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| Summary: | Well established guidelines already exist that address best practices for Non-Interventional Study (NIS) design and methods. These guidelines provide advice on things to consider while designing a study and developing a protocol, but do not necessarily capture specific details related to the implementation of NIS. The intent of this paper is to propose a best practice for conducting secondary use of data NIS. We propose that the ideal implementation of a NIS should include the development of a strong Study Concept, followed by a detailed Protocol, Analysis Plan, Report, and considerations for Dissemination.
We review and discuss common mistakes/pitfalls and key considerations at each step from concept to publication. In many cases in this review, we have also provided suggestions or accessible resources that researchers can apply as a “best practices” guide when planning, conducting, or reviewing this investigative method. |
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| ISSN: | 2327-2236 |